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ICT10110.1177/1534735410387418Kov ačič and KovačičIntegrative Cancer Therapies © The Author(s) 2011 Reprints and permission: http://www.sagepub.com/journalsPermissions.nav Reprints and permission: http://www. sagepub.com/journalsPermissions.nav
Impact of Relaxation Training According to Yoga in Daily Life® System on Perceived Stress After Breast Cancer Surgery
Integrative Cancer Therapies 10(1) 16–26 © The Author(s) 2011 Reprints and permission: http://www. sagepub.com/journalsPermissions.nav DOI: 10.1177/1534735410387418 http://ict.sagepub.com
Tine Kovacˇicˇ, MSc1, and Miha Kovacˇicˇ, PhD2, 3
Abstract The purpose of this pilot study was to gather information on the immediate and short-term effects of relaxation training according to Yoga In Daily Life® (YIDL) system on the psychological distress of breast cancer patients. 32 patients at the Institute for Oncology of Ljubljana were randomized to the experimental (N = 16) and to the control group (N = 16). Both groups received the same standard physiotherapy for 1 week, while the experimental group additionally received a group relaxation training sessions according to YIDL® system. At discharge the experimental group was issued with audiocassette recordings containing the similar instructions for relaxation training to be practiced individually at home (for further 3 weeks). An experimental repeated measures design was used to investigate the differences over 1 month period in stress levels, changes in mental health and psychological parameters. Measures were obtained at three time points during the study period: baseline, at 1 week, and at 4 weeks, by blinded investigators using standardized questionnaires General Health Questionnaire-12 (GHQ-12), Rotterdam Symptom Checklist (RSCL) psychological subscale, Perceived Stress Scale (PSS). Patients who received relaxation training reported feeling significantly less distressed during hospitalization and after discharge-period than did the controls that did not receive relaxation training. The results indicate that relaxation training according to Yoga in Daily Life® system could be useful clinical physiotherapy intervention for breast cancer patients experiencing psychological distress. Although this kind of relaxation training can be applied to clinical oncology in Slovenia, more studies need to be done. Keywords breast cancer, psychological distress, relaxation training,Yoga in Daily Life, experimental repeated measures design, standardized questionnaires
Introduction During the past 30 years, studies of psychological reactions have repeatedly drawn attention to persistent and serious levels of distress, which continue to disrupt the everyday lives of women long after breast cancer treatment has been successfully completed.1,2 This distress is in itself both disabling and indicative of poorer overall recovery.3,4 Estimates of the prevalence of significant psychological distress or disruption such as depression, anxiety, chronic sorrow, feelings of sadness, anger–hostility, confusion–bewilderment, fatigue specific to surgery, fatigue specific to chemotherapy, fatigue specific to radiation, and hopelessness have ranged from between 23% and 85% of breast cancer population studied.1-20 This variation is partly because of the fact that psychological distress varies with the type of cancer treatment and the stage of cancer. Despite the prevailing belief
that patients with early stages of breast cancer and good prognoses should have “nothing to worry about,” it is apparent that patients with newly diagnosed cancer, regardless of their prognosis, exhibit symptoms of psychological distress.12 Relaxation as a stress management technique is widely used as an adjunct to traditional medical cancer therapies. Relaxation training has been found to reduce psychological distress in oncology settings.21-25 Several studies have 1
Centre for Education, Work and Care Dobrna, Dobrna, Slovenia Štore Steel d.o.o., Štore, Slovenia 3 University of Nova Gorica, Lepi pot 11, 1000 Ljubljana, Slovenia 2
Corresponding Author: Miha Kovacˇicˇ, Štore Steel d.o.o., Železarska cesta 3, 3220 Štore, Slovenia Email:
[email protected]
17
Kovacˇicˇ and Kovacˇicˇ explored the effects of specific relaxation techniques on psychological distress, control, coping, and survival. Although a number of investigators have advocated the use of relaxation techniques for cancer patients, there are few wellcontrolled studies.12,25-31 The basic premise of this study is to include relaxation training according to the Yoga In Daily Life® (YIDL) system as an integral part of rehabilitation program in physiotherapy. The overall aim of this pilot study is to examine the effects on psychological distress in breast cancer patients. It was hypothesized that patients receiving relaxation training according to YIDL would evidence significantly less psychological distress/morbidity than patients assigned to the control group.
Methods Participants The independent coordinator was asked to screen 32 women in care at the Institute for Oncology of Ljubljana with a primary diagnosis of breast cancer using the eligibility criteria (Table 1). For each patient identified by the coordinator, permission was gained to contact her and ask her willingness to participate in this study. They were told that the study was being carried out to evaluate relaxation training during hospitalization (after the surgery) and its impact on psychological parameters. The sample was made up of a consecutive series of patients who had been treated by either modified radical mastectomy or breast conserving surgery (lumpectomy, quadrantectomy, segmental mastectomy) for early breast cancer stages I and IIA, IIB, that is classified using the recognized TNM system (Table 2), which identifies the tumor size (T), lymph node involvement (N), and presence of secondary tumors or metastases (M) as defined by Box32 and Curling and Burnet.33 Initially, 40 women fulfilled the study criteria but 8 refused to participate. Reasons given were too fatigued (n = 2), too distressed (n = 5), and unknown reason (n = 1). Informed consent was given by remaining 32, who were then randomly assigned to either an experimental or control condition. A total of 32 patients were randomized (stratified randomization) either to the standard physiotherapy (control group, n = 16) or to a standard physiotherapy plus relaxation training according to the YIDL system (experimental group, n = 16) before the surgery. It was also decided not to include a placebo group for ethical reasons. The Latin Square randomization method was used in the study. Stratifying factors were type of surgery, severity and stage of breast cancer, and sociodemographic characteristics (age, marital status, employment status, education). Baseline values between experimental and control group regarding stratifying factors were successfully equalized (see Table 3).
Table 1. Inclusion and Exclusion Criteria for the Study Population Inclusion Criteria Initial diagnosis: breast cancer Stages I and II breast cancer Postoperative hospitalization: 1 week 40 years of age or older Surgical options: breast conserving surgery (BCS) or radical modified mastectomy (MRM)
Patients who were willing to accept the randomization to any group Multimodal therapy (surgery, radiotherapy, chemotherapy)
Exclusion Criteria Known and documented psychiatric disorders Active substance abuse (a history of dependence on alcohol or drugs, taking psychotropic drugs) Stages III and IV breast cancer Patients with seriously impaired hearing Patients with seriously reduced cognitive capacity (patients who did not understand the information given about the study and/or who could not be expected to have the ability to follow the instructions in a relaxation training) Patients who have received psychotherapy
From Table 3 we can see that regarding sociodemographic and clinical variables there were no statistically important differences between the experimental and control groups. The age differences between both groups were also not statistically significant, t(30) = −0.136; P = .893. Approval from the ethics committees of University of East London and the Republic of Slovenia was obtained before the initiation of the study. Written informed consent was obtained from all patients. A randomization list was prepared by the independent statistician using the random permuted blocks technique.34,35 This technique ensured that equal numbers of patients within each stratum were randomized to each intervention (restricted stratified randomization). Although patient blinding was impossible, the other physiotherapists and health professionals providing standard care had no knowledge of group assignment (single blinding).
Measures and Procedures Relaxation training according to the YIDL system was chosen as a complementary treatment option (mind–body intervention) to plan a program to promote coping and adjustment to breast cancer treatment and to improve quality of life. Although a number of investigators have
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Integrative Cancer Therapies 10(1)
Table 2. The TNM Classification System TNM Classification
Clinical Stage
T1, N0, M0
Tumor ≤2 cm, confined to the breast, no lymph node or metastatic involvement No primary tumor to tumor ≤5 cm, no or only ipsilateral moveable axillary lymph node involvement, no metastases Tumor >2 cm, no or only ipsilateral moveable axillary lymph node involvement, no metastases
I
T0-2, N0-1, M0
IIA
T2-3, N0-1, M0
IIB
Description
Table 3. Descriptive Statistics for Sociodemographic and Clinical Variables by Experimental and Control Group Group Frequency Percentage df Marital status
Married or cohabiting Separated or divorced Widowed
Single. never married Employment Employed status Retired Educational status Type of breast cancer surgery
Housewife High school College Breast conserving surgery Modified radical mastectomy
EG CG EG CG EG CG EG CG EG CG EG CG EG CG EG CG EG CG EG CG
11 13 1 1 3 2 1 0 13 11 1 4 2 1 8 8 8 8 6 6
68.8 81.3 6.3 6.3 18.8 12.5 6.3 0.0 81.3 68.8 6.3 25.0 12.5 6.3 50.0 50.0 50.0 50.0 37.5 37.5
EG CG
10 10
62.5 62.5
P
3 .713 2 .317 1 1.000 1 .642
Note: EG = experimental group; CG = control group.
advocated the use of relaxation techniques for cancer patients there are few well-controlled studies.12,25-27,29-31 Data on age and demographic characteristics, diagnosis, type of breast cancer, breast cancer surgery, and cancer staging were compiled from the medical records. Outcome measures were obtained at the Institute for Oncology of Ljubljana at 3 time points:
a. at baseline (after the surgery) b. at 1 week (1 week postattendance; at discharge) c. at 4 weeks (4 weeks postattendance); prior the commencement of radiation Outcome measures were obtained by blinded investigators (physiotherapists) using standardized questionnaires. Single blinding was used to maintain the ignorance of assessors about which group the patients have been assigned to (blinding) and to eliminate assessors’ effects by excluding personal interaction with patients (they received standardized letters, scales, tape-recorded instructions and self-completion questionnaires). The oncologists, nurses, physiotherapists, and other health profess ionals were also blinded to the patients’ General Health Questionnaire-12 (GHQ-12),36 psychological subscale of the Rotterdam Symptom Checklist (RSCL),37 and the Perceived Stress Scale (PSS)38 scores, but they were aware that the assessment of psychological distress was being made. GHQ-12 is 12-item scale, which is a measure of generalized psychological distress. The GHQ-12 does contain questions that elicit “somatic” symptoms and does not make clinical diagnoses. It may, therefore, be expected to produce more false positives in patients with breast cancer. Scores on the GHQ-12 range from 0 to 36 (Likert-type scoring, where responses score 0, 1, 2, or 3) and measure nonspecific psychological morbidity/distress. Higher scores indicate level of psychological distress that is consistent with a need for psychological intervention. The psychological subscale of the RSCL was used to measure psychological distress of patients with breast cancer. The RSCL is a 43-item questionnaire that provides a total score that reflects psychological and physical functioning, and disease- and treatment-related items. The RSCL psychological subscale is an 8-item scale assessing psychological symptom distress on a 4-point Likert-type scale. Scores on the RSCL psychological subscale range from 0 to 24 (Likert-type scoring, where responses score 0, 1, 2, or 3) and measure psychological distress in breast cancer patients. The PSS-14 was designed to measure the degree to which situations in one’s life are appraised as stressful. The 14 items refer to subjective appraisals of events occurring within a 1-month time frame. The PSS-14 consists of 14 items. Higher scores indicate more perceived stress. The study length of 1 month was chosen to allow for time to show a clinical effect, to minimize the potential for compounding medical complications, and to reduce the likelihood that reactive and/or situational distress would have spontaneously resolved. The inclusion of a nontreatment arm was viewed as desirable to control for placebo effect and change over time, and was therefore included. It is recognizable that blinding is often not feasible, particularly in evaluating
Kovacˇicˇ and Kovacˇicˇ psychological treatments, but it is not advisable for the person (author-researcher) who delivers the relaxation to administer the assessment as well.26 Baseline measurements were made after the randomization to serve as a check on the effectiveness of randomization in equalizing both groups. Control group received surgery and attended 1-week standard physiotherapy program during which they have remained hospitalized. After hospitalization, they received adjuvant systemic chemotherapy (based on the tumor size, spread to lymph nodes, and/or prognostic features) and external radiation therapy to the lymph nodes near the breast and to the chest wall after a modified radical mastectomy (MRM; given in fifth week after the surgery). None of the patients in the control group was given neoadjuvant chemotherapy prior to surgery. Experimental relaxation group received surgery and attended 1-week standard physiotherapy program plus 1 hour group relaxation session per day. The participants were naive with respect to experience with relaxation training according to YIDL system though most had heard of this approach. After hospitalization, they received adjuvant systemic chemotherapy (based on the tumor size, spread to lymph nodes, and/or prognostic features) and external radiation therapy to the lymph nodes near the breast and to the chest wall after an MRM. None of the patients in the experimental group was given neoadjuvant chemotherapy prior to surgery. The physiotherapists provided standard physiotherapy program for breast cancer patients with appropriate exercise prescription and assisted in the education of the control and experimental group to • facilitate their recovery of shoulder range of movement and physical function of the operated arm; • increase their awareness of lymph edema, its prevention and early detection; and • minimize the effect of the development of secondary complications on their ultimate physical recovery. The aims of standard physiotherapy program in patients with breast cancer undergoing treatment for breast cancer are that women should regain their preoperative shoulder range of motion and function after the surgery; obtain knowledge of lymph edema, its prevention and awareness of its early signs; not have their wound drainage or length of hospital stay adversely affected by the commencement of shoulder movement; and minimize the effect of the development of secondary complications on their ultimate psychophysical recovery.
Relaxation Training According to the YIDL System The YIDL system39 is a practical system of health and lifestyle management, integrating every aspect of a person’s
19 being. The YIDL system consists of dynamic and static postures (asanas), breathing techniques (breathing exercises and pranayama), relaxation techniques (relaxation exercises, progressive muscle relaxation, deep relaxation techniques—yoga nidra), and meditation techniques (progressive levels of self-inquiry and imaginary meditation). The 4 main principles of this system are physical, mental, social, and spiritual health. Relaxation training according to the YIDL system consists of many relaxation techniques and practical instructions for the body relaxation, concentration, deep breathing to relax the whole body and to achieve mental relaxation and positive thinking. It must be emphasized that this relaxation training in cases of breast cancer should only be used as an adjunct to competent and comprehensive medical care and is not to be constructed as an independent, complete, and exclusive alternative treatment for cancer. All the patients with breast cancer in the present study saw the relaxation training as a supplement to, not as a substitute for, orthodox primary care. Relaxation training according to the YIDL system was chosen for several reasons. First, relaxation training is inexpensive, relatively easy to learn, and produces no negative side effects. Second, relaxation is “the diminution of tension and restoration of equilibrium following disturbance,”39 and its aim was to increase the patient’s self-control and improve their quality of life by teaching them to increase self-esteem, decrease psychological distress, reduce the stress, level of physiological arousal, transient and general anxiety, and thus enable them to mobilize better coping resources. The relaxation training sessions are not directed psychotherapy sessions but are aimed at decreasing stress, minimizing the sense of isolation, enhancing self esteem, and promoting mental and physical well-being of patients with breast cancer. Care was exercised to make the relaxation group meetings cordial but to minimize traditional group therapeutic effects. It was felt that to do otherwise would unnecessarily complicate interpretation of the data. It was emphasized that the ability to relax is a learned skill, requiring active participation and frequent practice by the patient. The relaxation training according to the YIDL system was conducted by the researcher. Training material was presented through one-to-one interaction, audio relaxation tapes, and homework practice of the relaxation training according to the YIDL system. The researcher had approximately 7 years of prior experience using relaxation training according to the YIDL system and 3 years of experience working with oncology patients. Because both the subjects and the researcher had known the experimental status, the delivery of relaxation training according to the YIDL system could not have been blinded, confounding the researcher with the intervention. Therefore it was impossible to separate the effect of the interaction from a researcher. To minimize this potential source of bias, the environment
20 and training duration were standardized. The procedures for each relaxation training session have been described in the book Yoga in Daily Life: The System39 to ensure that the same intervention was given to all. In addition, to minimize the possibility of confounding patient perception with effect, only patients who were willing to accept the randomization to any group were included. The relaxation training according to the YIDL system was taught live on 7 occasions during the 1 week postsurgery. It was conducted in groups of 3 patients. The sessions were held for 45 minutes in a quiet physiotherapy room with comfortable tables. When leaving the oncology unit, the patients in the experimental group were issued audiocassette recordings containing similar instructions for relaxation training according to the YIDL system to be practiced individually at home (prior to chemotherapy/radiation therapy). They were asked to practice relaxation at least daily for a further 3 weeks at home. The description of the procedure for the interventions is given in Table 4. The diary recordings (postcards) were made each day to indicate compliance and to document their frequency of practice or any acute illness, medication usage, interpersonal or other changes in their lives. Patients and their physicians were also asked about taking any anxiolytics, antidepressant, and other medical treatments, or complications that might have occurred during the study period, and whether any personal events (eg, death of a relative or an accident) had occurred that could have substantially altered their psychological and mental states. According to analysis of diary recordings there were no such factors that could have substantially altered their psychological well-being. Inspection of the home record sheets also indicated that all patients in the relaxation training condition succeeded in keeping accurate records on their home practice. All patients found the audiotapes beneficial for practicing the relaxation at home and reported practicing it from 5 to 7 times weekly (for 3 weeks). Patients described fitting the relaxation into their daily routine and establishing a daily pattern of listening to the tape. Patients were asked about other medications and medical treatments, or complications that might have occurred during the study period, and whether any personal events (eg, death of a relative or an accident) had occurred that could have substantially altered their psychological and mental states.
Data Analysis The data were analyzed using the Statistical Package for Social Sciences (SPSS) program version 16.0 (α was set at.05). The χ2 test or Fisher’s exact test was used to compare differences in the distribution of sociodemographic and clinical details for categorical variables, and t test was used for continuous variables. One-sample Kolmogorov–Smirnov test was used to test for normality.
Integrative Cancer Therapies 10(1) Table 4. Procedure for the Intervention Intervention Level
Activities
Initial relaxation
Normal breathing, concentration on the whole body Abdominal Slightly deeper than breathing normal breathing for coordination of breath and abdomen movement, concentration on the abdomen Full yoga breathing Full use of lung capacity breathing, for coping with fears, concentration on one’s entire trunk Formulation Setting goals for the of intention future to cope with statement uncertainty and fears, (Sankalpa) mental concentration Body scan Focusing on sensory awareness of a series of individual muscle groups Reaffirming Mental concentration of intention statement (Sankalpa) End of relaxation Concentration on the whole body
Duration (min) 5
5
5
5
15
5
5
Repeated measures analysis of variance (ANOVA) was used to analyze the within-subject changes over time (changes of quantitative data from pretest to 1 week postoperation and 4 weeks postoperation) as well as between-subject differences related to other independent factors in the model. For post hoc testing, a Bonferroni correction was applied.
Results Psychological Distress as Measured With GHQ-12 Repeated measures ANOVA tests of between-subjects effects showed that in general the type of surgery itself did not have statistically important impact on values of GHQ-12, F(1, 28) = 3.727, P = .064; nor was the interaction between treatment (experimental/ control group) and type of surgery statistically important, F(1, 28) = 2.551, P = .121. On the other hand, the treatment itself in general had a statistically important impact on outcome measures of GHQ-12, F(1, 28) = 55.374, P < .0005.
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Kovacˇicˇ and Kovacˇicˇ When testing the within-subject effects, there was a statistically significant change over time in GHQ-12 scores in both the control and experimental groups, F(1, 28) = 84.313, P < .0005. Post hoc testing showed that there was no statistically significant difference in mean score of GHQ-12 (P = .745) between the experimental (21.00 ± 6.218) and control (20.37 ± 4.395) groups at baseline. Statistically significant differences (P = .0005) of means were noted at 1 week postattendance measurement for the experimental (9.81 ± 2.971) group. However, the control group had comparable mean score of GHQ-12 (19.63 ± 4.048) at 1 week postattendance (P > .05). There was a statistically significant (P = .0005) decrease in psychological distress demonstrated by improvements in the GHQ-12 for the experimental group at 4 weeks postattendance (3.56 ± 2.421). Analysis of the GHQ-12 indicated that the psychological distress in the control group increased significantly at 4 weeks postattendance (21.13 ± 4.617, P < .05; see Table 5). From the above information, it can be seen that psychological distress among participants in relaxation training group decreased significantly over the study period whereas it increased significantly in the control group. These results together with the tests of between-subjects effects indicate that relaxation training according to the YIDL system had a significant impact on decreasing the psychological distress as measured with GHQ-12 among participants in the experimental group over the study period.
Psychological Distress as Measured With Psychological Subscale of RSCL ANOVA tests of between-subjects effects showed that in general the type of surgery itself did not have a statistically significant impact on values of the psychological subscale of RSCL, F(1, 28) = 2.012, P = .167; nor was the interaction between treatment and type of surgery statistically important, F(1, 28) = 1.141, P = .295. On the other hand, the treatment itself in general had a statistically significant impact on outcome measures on psychological subscale of RSCL, F(1, 28) = 86.471, P < .0005. When testing the within-subject effects, there was a statistically significant change over time in the RSCL psychological subscale scores for the experimental but not for the control group (F = 147.856, P < .0005). Post hoc testing showed that there was no statistically significant difference in mean score of RSCL psychological subscale (P = .281) between the experimental (15.88 ± 2.895) and control (17.06 ± 3.214) groups at baseline. Statistically significant differences (P = .0005) of means were noted at 1 week postattendance measurement for the experimental (7.06 ± 2.351) group. However, the control group had comparable mean score of RSCL psychological subscale (16.69 ± 3.842) at
Table 5. Changes Within Groups Over Time on Outcome Measures Values on GHQ-12, Psychological Subscale of RSCL, and PSS Over the Study Period 1 GHQ-12 EG CG RSCL EG CG PSS EG CG
2
3
n
M
SD
M
SD
BCS MRM Together BCS MRM Together
6 10 16 6 10 16
21.17 20.90 21.00 23.33 18.60 20.37
7.76 5.57 6.22 5.75 2.12 4.40
9.50a 10.00a 9.81a 22.00 18.20 19.63
BCS MRM Together BCS MRM Together
6 10 16 6 10 16
15.17 16.30 15.88 15.67 17.90 17.06
2.79 7.17a 2.14 1.67a 3.02 7.00a 2.58 1.70a 2.90 7.06a 2.35 1.69a 2.73 15.50 3.89 16.33 3.31 17.40 3.84 19.30 3.21 16.69 3.84 18.19
BCS MRM Together BCS MRM Together
6 10 16 6 10 16
35.33 31.70 33.06 35.33 29.50 31.69
9.05 5.29 6.88 3.98 3.34 4.53
M
1.22 4.50a 3.71 3.00a 2.97 3.56a 5.18 24.17b 2.53 19.30 4.05 21.13b
16.17a 17.40a 16.94a 33.83 32.00 32.69
SD 2.59 2.26 2.42 5.27 3.20 4.62 1.51 1.57 1.49 2.80 3.53 3.51 5.42 3.78 4.33 4.07 4.76 4.47
Note: GHQ-12 = General Health Questionnaire-12; RSCL = Psychological Subscale of Rotterdam Symptom Checklist; PSS = Perceived Stress Scale; EG = experimental group; CG = control group; 1, at baseline; 2, at 1 week postattendance; 3, at 4 weeks postattendance; BCS = breast conserving surgery; MRM = modified radical mastectomy. a P < .01. b P < .05.
1 week postattendance (P = .270). Statistically significant improvements in the psychological distress subscale (P = .0005) were found for the experimental group at 4 weeks postattendance (1.69 ± 1.493). Analysis of the RSCL psychological subscale indicated that the control group worsened, but not significantly at 4 weeks postattendance (18.19 ± 3.507, P = .058; see Table 5). From the above information, it can be seen that the psychological distress among the patients in the experimental group decreased significantly over the study period, whereas it increased in the controls. These results together with the tests of between-subjects effects indicate that relaxation training according to the YIDL system had a significant impact on decreasing the psychological distress as measured with psychological subscale of RSCL among participants in experimental group over the study period.
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Degree of Stress in Patients’ Lives Before and During Postoperative Period as Measured With PSS ANOVA tests of between-subjects effects showed that in general the type of surgery itself did not have statistically significant impact on values of PSS, F(1, 28) = 2.806, P = .105; nor was the interaction between treatment and type of surgery statistically significant, F(1, 28) = .768, P = .388. On the other hand, the treatment itself in general had a statistically significant impact on outcome measures on PSS, F(1, 28) = 25.035, P < .0005. When testing the within-subject effects, there was a statistically significant change over time in PSS scores for the experimental but not for the control group, F(1, 28) = 68.465, P < .0005. Statistical analysis showed that the mean PSS scores of both groups were considerably high at baseline (experimental, 33.06 ± 6.884; control, 31.69 ± 4.527) indicating high perceived stress for both groups (see Table 5). As can be seen from Table 4, by 1 month patients’ mean values for the experimental group of the PSS (16.94 ± 4.328) had decreased significantly (P = .0005). The mean scores of the perceived stress of the control group in contrast had increased after 1 month (32.69 ± 4.468) but not significantly (P = .253). From the above information, it can be seen that self-perceived stress levels among patients in the experimental group significantly decreased over the study period, whereas it remained unchanged in the controls. These results together with the tests of between-subjects effects indicate that relaxation training according to the YIDL system had a significant impact on decreasing the degree of stress in patients` life as measured with PSS among participants in experimental group over the study period.
Discussion Since this is the first study of yogic relaxation training according to the YIDL, system it is premature to form strong conclusions regarding the effects of relaxation according to the YIDL system. A need exists for additional, well-designed studies on this topic before a recommendation can be made regarding the efficacy of yogic relaxation as a nonpharmacological therapy for maintaining or increasing psychological well-being in patients with breast cancer. The elevated-risk profile for patients with breast cancer in both groups was evident by the significant distress at study entry, but it is noteworthy that all of them had been diagnosed 2 weeks prior to breast cancer surgery. It can be argued that the source of distress is continued involvement in treatment, as subjects from present study were going to receive radiotherapy and/or chemotherapy. Most of the psychological morbidity associated with breast cancer has been blamed on the radical nature of mastectomy.40 Little or no attention had been paid to the
Integrative Cancer Therapies 10(1) psychological burden of the disease itself or to the multiple problems that can be associated with additional systemic therapies.40 No statistically significant difference in baseline measurements between treatment groups was found in the present study. The incidence of psychological distress was high in both groups. These findings question the assumption that mutilating surgery per se is predominantly responsible for psychological morbidity. The degree of psychological distress among the patients treated by breast conserving surgery (BCS) was a disappointing finding, but one that cannot be ignored. These women clearly need just as much psychological support as patients who undergo modified radical mastectomy (MRM) as already argued by Fallofield et al41 and Munroe et al.42 There are, however, certain types of problems specifically related to type of treatment. In general, the differences between psychological adaptation following mastectomy and that following lumpectomy are qualitative, not quantitative.21 Unfortunately, breast conservation therapy does not categorically eliminate all the psychological distress associated with breast cancer. Present findings and findings of several previous studies of women’s adjustment to breast cancer over time indicated that many women experience substantial psychological distress and anxiety following diagnosis and surgery.43 However, it is possible to postulate a number of reasons for unexpectedly high psychological distress levels among the subjects. There would have been at least 2 potentially stressful postoperative events: distress perceived prior to initiation of chemotherapy/radiotherapy, confrontation of the nature of the disease, and the need for further treatment. Considering all acute and long-term effects, it is not surprising that a majority of radiation therapy patients suffer from significant distress, tension, feelings of helplessness and hopelessness, anxiety, depression especially before/prior to, at the beginning of, during, and following therapy.20,44,45 Radiation also involves significant disruption in daily activities for up to 3 months following treatment.20,44,45 Post hoc testing showed that on the GHQ-12 and RSCL self-rating scales, psychological morbidity/distress of experimental group decreased significantly over the 1-week period (at discharge) and also over the subsequent 3 weeks (prior to the commencement of chemotherapy and/or radiation). These results indicate that participation in the relaxation intervention according to YIDL was associated with a decreased change for the worse and an increased probability of change for better. There are several possible mechanisms through which relaxation training may have exerted its effects. First, the results might be explained by various “nonspecific” factors such as patient expectation of benefit and increased attention. The development of a supportive physiotherapist–patient relationship may have accounted for the stress-reducing
Kovacˇicˇ and Kovacˇicˇ effects of relaxation training. The classic weakness of present experimental design (treatment vs no treatment) is that it does not include a control group receiving placebo intervention to control for the effects of suggestion and attention.34 Although placebo controls may present ethical problems when one is working with patients with cancer, it is desirable to include such controls whenever possible to assess the impact of demand characteristics on the dependent variables. However, this possibility has been previously investigated and ruled out in a variety of cancer studies cited in the literature.46,47 A second and more likely mechanism contributing to the effectiveness of relaxation training is via an attentional diversion. That is, relaxation may exert its effect by diverting patient’s attention away from the psychological distress context and toward more pleasant and relaxing thoughts and feelings rather than on the worry, pain, and so forth, related to breast cancer. Several studies have documented the effectiveness of attentional diversion strategies for the reduction of psychological distress, anxiety,12,48 and it is likely that this aspect of present relaxation training according to the YIDL system contributed to its efficacy in patients with breast cancer. A third mechanism that may explain some of the effectiveness of relaxation training is the induction of a state of deep relaxation. Relaxation may reduce psychological distress through one or more mechanisms. First, by helping the patient to relax and reduce her muscle tension, relaxation training helps reduce directly the person’s anxiety and psychological distress, and thereby also reduces side effects such as physiological arousal that is due to or exacerbated by high levels of arousal and anxiety. Second, relaxation may reduce psychological distress indirectly by reducing anxiety. Anxiety, because of its association with the side effects of cancer diagnosis and treatment, may become a conditioned stimulus for psychological distress and may also contribute directly to the stressfulness of overall breast cancer experience. Therefore, by reducing the anxiety, relaxation training may reduce the cues for psychological distress and relieve some of the psychological distress that normally accompanies each treatment. A fourth mechanism that may explain some of the effectiveness of relaxation training is inspiring hope. Physiotherapist– researcher relationships could have played a significant role in influencing inspiring hope in patients with breast cancer. It is well known that hope functions as a foundation for dealing with life’s stressors and guides cancer patient’s actions.49 Strong hope gives cancer patients the strength and courage to move forward in handling stressful or difficult situations, whereas hopelessness can lead to passivity and resignation50,51 suggesting that inspiring hope begins as soon as cancer patients become active participants in their complementary care. Health care professionals influence hope by actions, words, and nonverbal messages.49 Therefore it can be hypothesized that physiotherapist-researcher in present study could have increased
23 hope by giving patients a sense of control through providing stress management technique. Finally, many of our patients reported that their ability to use the relaxation technique was followed by observed reductions in their anxiety or psychological distress, decreased feelings of helplessness, and discomfort from the scar, and finally allowed them to feel that they had some control over their disease and lives during the 3-week postoperative period. Previous research has also shown that breast cancer patients who have a sense of control over events and actively take part in rehabilitation and complementary therapy adjust better than those with a helpless outlook.52,53 Thus, the effects produced by the relaxation procedures extended well beyond those attained by standard medical care and standard physiotherapy alone. However, there is at least one potential problem with the interpretation of results of psychological distress that needs acknowledgement. Any screening instrument, by definition, will have imperfect sensitivity and specificity, although there have been at least 20 studies showing that both of these are very good for the GHQ-12 and the RSCL. GHQ-12 was developed to measure nonspecific psychological morbidity. It must be noted that distinct diagnostic categorization could be inappropriate in the palliative care patient group.54 A broad concept of general psychological distress may be more appropriate.54 This instrument has high internal reliability and validity and has been used in many breast cancer/cancer studies.54-61 The RSCL has been rated the best available combination for measuring psychological components of health-related quality of life of patients with breast cancer.37 The scale’s psychometric properties are reported to be good, with α reliability of .88 to .94 on the psychological symptom subscale.37 The RSCL62,63 has also been used in a number of cancer investigations.3,64-69 In our study, the relaxation training was time limited (approximately 30 hours for 16 patients during hospitalization). It can be implemented in research studies and/or clinical care areas to promote stress management technique such as relaxation techniques rather than passive acceptance of illness. Finally, whereas other studies cited in the literature have dealt mainly with patients with advanced disease and poor prognosis, our study, to our knowledge, is the first to report on patients with early-stage breast cancer and good prognoses. These patients are part of a rapidly growing group of individuals who must learn to live with having had cancer, and they are ideal subjects to benefit from early complementary interventions. The present study has focused only on time during and shortly after breast cancer surgery. One reason for this may be assumption that quality of life gradually returns to normal over time.70 However, growing evidence suggests that negative psychological changes related to treatment persist long after therapy completion.71,72 This time represents the most difficult period
24 for most patients with breast cancer.73 It is characterized by difficult and sometimes painful diagnostic procedures, uncertainties, fear of recurrence, and for most patients, psychological distress.73 Because Slovenian oncologists are most likely to recommend conventional treatments to women with breast cancer, their preference for drug studies may result in many potentially eligible women not being offered the opportunity to participate in studies of relaxation interventions. Unless this issue is addressed, recruitment of patients with breast cancer in studies of relaxation interventions may be jeopardized, and the role of these interventions in the management of women with breast cancer may remain poorly understood. This is particularly concerning given the important survival effects that have been reported in early randomized trials of psychosocial interventions in women with breast cancer.12,25,74 Research is needed to understand the process by which priorities are assigned to competing clinical trials, the extent to which different constituencies ascribe to different types of interventions (eg, relaxation techniques [behavioral] vs pharmacological) and different potential outcomes (eg, quality vs quantity of survival). Moreover, the present study suggests that many patients are able to successfully induce relaxation after several researcher-physiotherapist–directed sessions, thereby increasing the likelihood of relaxation’s continued protective effects and its overall cost effectiveness. Thus, once patients learn to relax, professionally prepared audio taped instructions may be useful in maintaining the beneficial effects. Taken together, these findings suggest that the early introduction of relaxation training may have several clinical advantages in reducing the distress of breast cancer treatment. One obstacle to mass adoption of this relaxation training is the patient’s initial resistance to any need for psychological treatment. Because quality of life is defined in terms of the individual needs and priorities and is not simply a function of the presence or absence of specific psychological symptoms, future interest should focus on individualized qualityof-life measures.
Conclusions This investigation will add to the accumulating body of research that empirically documents the effects of relaxation interventions as health-promotion strategies on mental health of hospitalized oncology patients. Although this pilot study using a clinical trial design is too small to address the scientific hypotheses of interest, it provides researchers both important data and the necessary experience to carry out a large-scale clinical trial capable of examining the potential role of this specific relaxation training on psychological well-being, mental and physical health, and quality of life.
Integrative Cancer Therapies 10(1) The article presents short-term effects of relaxation training according to the YIDL system on the psychological distress of patients with breast cancer. Although the present results are provocative, caution in their interpretation is warranted for several reasons. First, although statistically significant differences between the experimental and control groups were evident on a number of measures of psychosocial status, the clinical significance of these differences is difficult to gauge. Although, present results have clear theoretical, and methodological implications, this pilot study demonstrated only short-term effectiveness of relaxation training for Slovenian breast cancer patients in improving psychological distress, which was demonstrated by a rapid decrease in RSCL psychological subscale, GHQ-12, and PSS scores. Clearly, the long-term health implications of relaxation training according to the YIDL system on the clinical oncological status of patients and the effect of other sociodemographic variables on the psychological distress in the present study were not known and were not the object of the study. Therefore, with a larger sample, they remain a challenge for future research. Acknowledgment The authors would like to kindly thank Dr Ivan Verdenik and Mr Miha Zagoričnik for the statistical analysis and sharing their intellectual knowledge.
Declaration of Conflicting Interests The author(s) declared no potential conflicts of interests with respect to the authorship and/or publication of this article.
Funding The author(s) received no financial support for the research and/ or authorship of this article.
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