PSYCHO-ONCOLOGY, VOL. 3: 109-120 (1994) A RANDOMIZED STUDY OF A REHABILITATION PROGRAM FOR CANCER PATIENTS: THE ‘STARTING AGAIN’ GROUP GUNILLA BERGLUND*t, CHRISTINA BOLUND$, ULLA-LENA GUSTAFSSON” AND PER-OLOW SJODENS } Psychologist, Psychosocial Unit, Department of Oncology, Karolinska Hospital, S-104 01 Stockholm, Sweden. Psychiatrist, Psychosocial Unit, Department of Oncology, Karolinska Hospital, Stockholm, Sweden. “ Research ‘Nurse, Psychosocial Unit, Department of Oncology, Karolinska Hospital, Stockholm, Sweden. § Psychologist and Professor, Centre for Caring Sciences, Uppsala University, Glunten, S-751 83 Uppsala, Sweden SUMMARY This study compares, in a prospective randomized design, a rehabilitation ‘Starting again’ program for cancer patients (n= 98) and a control condition (n = 101). Assessments were carried out pre- and post-intervention and ‘at a 3 months follow-up. The program consisted of 11 structured, two-hour sessions run for a period of seven ‘weeks by an oncology nurse specialist assisted by experts in various fields. The contents focused on physical training, information and coping skills training. Patients in the ‘Starting again’ condition improved significantly more than controls with respect to physical training, physical strength, body avoidance, appraisal of having received sufficient information, fighting spirit and frequency of sleeping problems. Results indicate improvement with respect to the three areas focused on in the ‘Starting again’ program: physical training, information and coping skills training. INTRODUCTION By improving cancer patients’ mental well-being, rehabilitation interventions should enable the patient to take on the duties and routines of ordinary life and to leave the identity of being a patient behind. However, little systematic research has been devoted to the process of reha~ bilitation or evaluation of the effects of rehabilita- tion interventions. In a review of studies concerning psychosocial interventions with cancer patients, Watson (1983) points out several problems plaguing the interpre- tation of results: many patients are not aware of their cancer diagnosis; there is an absence of control groups; therapy and measurements of therapy effects are performed by the same person; statistical analyses are reported in insufficient detail; and the intervention is often not clearly described. All these errors in design, assessment, etc, often bias conclusions about the effectiveness of a particular program in a favourable direction. In Watson’s review, five studies of therapy administered in a group format were included (Blake, 1983; Bloom ef al., 1978; Ferlic et al., * Author to whom correspondence should be addressed. CCC 1057-9249/94/020109-12 © 1994 by John Wiley & Sons, Lid. 1979; Golonka, 1977; Spiegel ef al., 1981). Four of them used controls (Bloom et al., 1978; Ferlic et al., 1979; Golonka, 1977; Spiegel et al., 1981). With respect to the work of Ferlic et al, (1979) it is not clear whether a randomization procedure was used. Sixty patients agreed to participate in a group counselling program. Thirty were assigned to a treatment group and the control group of 30 patients was balanced for age, sex and education. Spiegel et al. (1981) used a randomization pro- cedure, although Watson refers to their controls as matched, One important problem of that study is the great loss of patients between randomiza- tion and start of treatment. With respect to outcome, only one of the studies reports a significant decrease in mood dis- turbance-less anxiety, fatigue and confusion (Spiegel e¢ al., 1981). One did not measure anxiety or depression (Ferlic et a/., 1979) and the others showed no effect on mood state (Blake, 1983; Bloom ef al., 1978, Golonka, 1977). Single posi tive results were: higher health locus of control (Bloom ef al., 1978), greater comfort about being part of the hospital system and greater confidence in the medical staff (Ferlic e¢ a/., 1979). Watson Received 18 March 1993 Accepted 3 December 1993110 (1983) concluded that there is insufficient evidence for support being provided on a routine basis. ‘A number of studies have added to our knowl- edge since Watson’s review in 1983. In a ran- domized study, thematic counselling individually (n=21) ot in a group (n= 28), one session per week for cight weeks was shown to be superior to no counselling (n= 31) in diminishing anxiety and depression and in improving psychosocial adjust- ment to cancer (Cain ef al., 1986). Counselling included the following aspects: what is cancer; causes of cancer; impact of treatment on body image and sexuality; relaxation; diet and exercise; relating to care-givers; talking with friends and family; and goal setting. The results were analysed by separate one-way analyses of variance before, after counselling and six months later rather than utilizing the repeated-measures potential inherent in the design. Heinrich and Schag (1985) reported a non- randomized study of group treatment of stress and activity management for cancer patients and their spouses. Patients and spouses in the treat- ‘ment group learned more than those in the com- parison group, but patients in both groups improved their knowledge with time. With respect to psychosocial adjustment, only time had a sig- nificant influence (Heinrich and Schag, 1985). In a randomized pre-/post-treatment evaluation of the ‘I can cope’ program (Johnson, 1985), patients in the treatment condition improved with respect to all three dependent measures: anxiety; the meaning of life; and knowledge about cancer. The program comprised about sessions: learning about the disease; coping with daily health problems; communication; like yourself; live with limits; and usable resources (Johnson, 1985). In another study, indicating that support is not very effective with respect to psychological adjust- ment, 41 patients were randomized to one of three conditions: group support; coping skills instruc- tion; or no treatment control (Telch and Telch, 1986). The controls got worse over time, the members of support groups grew only slightly better and the coping skills group showed superiority over the other two conditions. Two methodological aspects detract from the value of this study: only two assessments were used and a small number of patients was included. Another randomized study by Edgar ef al. (1992) was designed to answer the question ‘for whom’ and ‘when’. An early intervention group was compared to a late intervention group, at G. BERGLUND E7 AL. baseline, at 4 months (after the early interven- tion), at 8 months (after the late intervention) and at 12 months. The intervention was short and structured, only five sessions emphasizing problem-solving techniques, goal-setting, cogi tive reappraisal, relaxation training and the effec- tive use of resources. After the early intervention, there was no significant difference between groups. After the late intervention, the differences were significant with respect to’ all dependent measures: anxiety; depression; control and intrusion (iliness worry); and all in favour of the late intervention. At 12 months, only intrusions iffered in the same direction as at 8 months. Sub- group analysis revealed that, for breast cancer patients, there was no difference between early and late intervention, which was the case for other diagnoses. In conclusion, the literature indicates that the- matic counselling, individually or in a group is more effective than no counselling (Cain et al., 1986), that knowledge improves with time, but can improve even more with an information program (Heinrich and Schag, 1985), and that after an intervention, patients show at least short- term improvement with respect to many variables Glohnson, 1985), With the exception of breast cancer, a late intervention, at the time when work and leisure activities should be resumed might be preferable (Edgar et al., 1992). The interventions mentioned above were directed to all patients partaking in a certain con- dition, With the exception of the Telch and Telch the level of distress was not an on. In an earlier non-randomized study (Berglund et al., 1993) comparing participants in the ‘Starting again’ (SA) group program to a group of patients declining participation, those in the SA condition seemed more satisfied with information than did the comparison group. This difference continued during the follow-up year. The SA group participants also increased their social and physical activities more than the comparison group, but these improvements did not lead to a decrease in anxiety or depressive symptoms. The non-randomized design sets serious limits to the possibility of drawing firm conclusions about the effects of the program, which was the reason for the present study. The present prospective randomized study con- cerns a structured rehabilitation group program running for seven weeks, with 11 two-hour ses-REHABILITATION OF CANCER PATIENTS. sions. Emphasis is put on physical training, infor- mation and coping skills training. The group is led by an oncology nurse specialist assisted by experts in various fields. The study was designed to measure short-term effects (post-intervention and 3 month follow-up) with respect to physical training, physical strength, patients’ appraisal of having received sufficient information, activities, anxiety and depressive symptoms. In addition, an attempt was made to study differences of mental adjustment to cancer (Greer ef al., 1991). METHOD Aims ‘The purpose was to evaluate the effects of a short, structured rehabilitation program for cancer patients compared with no intervention. We hypothesized that patients in the program compared to controls would: (a) feel better informed; (b) be more active (physical activity, everyday activities); (c) suffer less from depression and anxiety, and achieve a higher level of fighting spirit and lower levels of helplessness, anxious preoccupation, fatalism and avoidance. Design ‘A prospective randomized control group design was utilized. Data were collected before (baseline) and after the group program. Follow-up data were collected at 3, 6 and 12 months post- ‘treatment. The 6 month and 1 year follow-ups will be reported elsewhere. The baseline data consist of patients’ questionnaire responses recorded the nurse’s office. Patients were told about the study and the necessity of the randomization pro- cedure. They were then asked to fill out the base- line questionnaire. They were told that we had an interest in following the rehabilitation process of all patients. After filling out the questionnaire, the participants were randomized between the SA group and the control group. Efron’s method of biased coin designs for randomization of small samples was employed (Hjelm-Karlsson, 1991). Thus, at the randomization of each individual patient, group sizes were forced towards equality by increasing proportionately the probability of assignment to the smaller group. The majority of patients in the control group it (64%, n= 65) did not receive any intervention. However, in order to study separately the effect of providing information in a concentrated form, the first 36 patients (36%) in the control group were offered one information session whereas the remaining 65 were not. The single information session contained the information given by the oncologist and the dietitian as part of the SA group program, although the possibilities for patients to discuss problems were limited. Inclusion criteria were curative treatment for a primary tumour, age below 75 years and start of group intervention within two months after finishing post-operative treatment (radio- and/or chemotherapy). Patients A total of 292 patients were approached from November 1987 until April 1990, 199 of which were included in the study, 98 in the SA group and 101 in the control group. Another 73 patients who declined group participation and randomiza- tion were monitored during the same period (data not presented). An additional 20 patients who were approached declined monitoring completely as they found the questionnaire to be a burden. ‘The mean age was similar in the groups, there ‘were few men and the majority were breast cancer patients. All patients had received adjuvant therapy. The most frequent additional treatment was the antihormone Tamoxifen. Most patients were married. The most frequent profession was secretarial or office work. Of the SA group 17% were retired as were 12% of the control group. There were no significant differences between the SA group and the control group with respect to any of the variables in Table 1. ‘The response rate at post-measure was 92% (n= 90) in the SA group and 97% (m= 98) in the control group and at three months 91% (n= 89) and 92% (n= 93). Patients were reminded up to three times to answer the questionnaires. In the SA group at post-measure, seven patients failed to answer the questionnaire for unknown reasons, while one patient did not answer because she was blind. In the control group, one patient dropped out for an unknown reason and two because of recurrence. The ‘Starting again’ program ‘The program included 11 two-hour sessions run for a period of seven weeks. An oncology nurseG. BERGLUND ET AL Table 1. Age, gender, diagnoses, type of curative and additional adjuvant treatment, marital status and occupation for SA and Control groups at randomization OO Mean values ——— 98% confidence SA Control p interval Age S25 539 NS. (test) $2.32-54.56 No. of patient SA Control at Gender Male 4 3 Female 4 98 NSO) 1 Diagnosis Mammae Ovarian Testicular Prostate Others Mo NS.G?) 4 Curative treatment Radiation, 1 0 Chemotherapy 7 2 Radiation+ Chemotherapy 16 19 NS.G°) 2 ‘Adjuvant treatment Tamoxifen 18 a Other 26 9 No additional medicine 6 S$ NS.O2) 2 Marital status Married 2 n Widowed 9 7 Single 20 ty Other relation 6 6 NS.) A Type of occupation Retired 2 7 Office work 2% 24 Health sector 3 9 Nursery school 3 4 Teacher 7 6 Others “4 37 NS.) 3 served as the group leader and was assisted by a co-leader responsible for the content of the session. The first four weeks consisted of two sessions per week, one devoted to physical training and one to information, and the last three weeks entailed one session per week of coping training. Physical training (four sessions). The sessions were lead by a physical trainer. The program was developed for patients who had recently received intense treatment. The aims were to increase mobility, muscle strength and general fitness. As the majority were breast cancer patients, someREHABILITATION OF CANCER PATIENTS 13 exercises were especially designed for them. Relaxation was part of every physical training ses- sion. Two relaxation methods were used: pro- gressive muscle relaxation (two sessions) and relaxation with positive images (two sessions). Home assignments were not used, but patients were provided with written instructions of the progressive muscle relaxation and had the oppor- tunity to buy a relaxation tape including sugges- tions of positive images. Information (four sessions). Every session was conducted by an expert. An oncologist informed about cancer in general and the effects of radi- ation, chemotherapy and hormonal treatments. Patients were given ample opportunity to ask questions and to discuss matters of interest. A psychologist informed about the concept of crisis, and emotional reactions to different phases. The concept of development through crises (Cullberg, 1975) was also introduced. A dietitian informed about what is important in the diet, about the relation of health and diet and how to prepare healthy food. The oncology nurse group leader ran the last information session herself, She informed about alternative treatments and health centers. Patients were encouraged to share experiences. Coping (three sessions). A psychologist was responsible for all three sessions. The first was dedicated to role playing of returning to work: how to handle problem situations such as people asking too much; people asking too little; and peculiar attitudes towards cancer. The second was devoted to anxiety: what is anxiety; why do we feel anxiety; and how can we handle it, The third session dealt with problem situations at medical check-ups: how to handle situations and to claim patients’ rights. Outcome measures The post-treatment measure was applied 2-6 weeks after the termination of the program and patients were asked to evaluate the last week. We employed the same questionnaire as in our pre-~ vious study of the ‘Starting again’ program (Berglund et al., 1993). The following subscales] variables were included (1) Background variables: gender, age, diag- nosis, treatment, occupation, marital status, (2) Work, sick leaves and membership in patient organization. With respect to all continuous variables patients were asked to rate on a scale from 0 to 4 to what extent specific activities, physical sequelae and mood states applied to them during the previous week. Zero indicates absence of problems or activity performed every day, 1-4 indicate the degree of problem, intensity of symp- toms or frequency of activity. (3) Physical strength and activity: 21 items divided in five subscales and two single items: physical training (three items), physical strength (six items), tiredness (three items), activity without resting during the day (one item), body image (four items), pain (three items), global health (one item). (4) Patient appraisal of having received suffi cient information: six items and a single item about having changed life style and habits after the cancer diagnosis. (8) A modified. HAD scale (Zigmond and Snaith, 1983): 11 items in two subscales: ‘anxiety signs (five items) and depressive signs (six items). One item in the depressive symptom scale (‘I still enjoy the things I used to enjoy’) and two in the anxiety symptom scale (‘I get a sort of frightened feeling as if something awful is about to happen, I get a sort of frightened feeling like “butterflies” in the stomach’) were omitted due to low cor- relations between these items and the total score in another study (Aronson, personal communication). Snaith (1987) has stated that the number of items composing the scales could vary between four and 10 without changing their performance. In a recent HAD study of cancer patients at Radiumhemmet, alpha levels never decreases below 0.86 when each of the 14 items were deleted individually (Brandberg, personal communication). Five response categories were used: never, seldom, sometimes, often and always, coded from 0-4 depending on if the statement was a positive or negative one. The reason for using five categories in the HAD scale was to maintain the response format used in previous questions. Cutoffs for the modified scales were computed by linear scale transformation on the basis of values given in (Cohen and Cohen, 1983). This resulted in the following limit Anxiety: 0-7 (normal level), 8-20 (bor-14 derline/severe level) and Depression: 0-8 (normal level), 9-24 (bordertine/severe level). (© Quality of life: two global items. (7) Communication with staff: 11 items from the Cancer Inventory of Problem Situations (Heinrich er al. 1984). This part was added for the last patients entering the study, 50 in the SA group and 56 in the control group. (8) Activities (Sjddén, 1983): 16 items, activities at home (nine items) and in the community (Seven items). (9) Symptoms typical for breast cancer (Berglund ef a/., 1991): 20 items, for which both frequency and burden were measured. Throughout the questionnaire, a higher figure indicates a higher degree of problem. During the last part of the study, the following instrument was added: (10) The Mental Adjustment to Cancer Scale (Greer and Watson, 1987) was used for the last 1.52 years (149 patients: 73 in the SA group and 76 controls). The MAC-scale con- sists of five subscales representing different psychological responses; fighting spirit (16 items), helpless (six items), anxious preoccu- pation (nine items), fatalistic (eight items) and avoidance (one item). A higher value implies a higher degree of psychological response. Statistical methods All numerical scale values presented are derived by summing individual items. A. x? test was used on all dichotomous back- ground variables and ¢-tests on all continuous background variables. Results are presented in terms of the factor-analytically derived scales employed in a previous study (Berglund ef al., 1993) unless present factor analyses (varimax rotation) deviated from that pattern. This occurred only for the body image items and for physical symptoms, for which new scales were employed. For items to be included in a scale, inter-item correlations of >0.35 and factor load- ings >0.45 were required. Repeated measures analyses of variance (ANOVA) were applied to all dependent con- tinuous variables, provided there was no significant between-groups difference at baseline G. BERGLUND ET AL (test). When ANOVA showed a significant Groups by Time interaction, post-tests of between group differences and within-group differences over time were applied: Tukey (two mean values) or Scheffé (more than two mean values) (Kirk, 1968), When groups differed significantly at base- line, analysis of variance of gain scores was implemented. In this case, the main effect of group was the focus of interest. If significant, this effect was further examined by pairwise compari- ‘sons using the Tukey test. RESULTS At baseline, 72% in the SA. group and 63% in the control group did not work. At the end of treat- ‘ment, this number decreased to 29 and 25% and three months later to 23 and 25%, respectively (x’, df= 1, ns). Sick-leaves diminished from 72 to 20 and to 10% in the SA group and from 54 to 18 to 17% in the control group during the same period of time (x?, df =I, ns). The SA group had significantly more problems with physical training than the control group at baseline [#(195) = 2.66, p= <0.01]. The ANOVA of gain scores showed a significant group differ- ence [F(1, 171) = 11.23, p = 0.001] (Table 2) indi- cating a positive effect of treatment. Thus, problems with physical training, as compared to baseline, was significantly more improved in the SA group than in the control group both at post- measure and at the 3 month follow-up (Tukey) (Table 2), Physical strength differed __ significantly [c(197) = 2.82, p= <0.01] between groups at pre- measure. Analyses of variance of gain scores (Table 2) showed a significant difference between groups [F(1,177)= 12.13, p< 0.001]. Both at post measure and at 3 months, the SA group had improved significantly more than the control group compared with baseline (Tukey). In both groups, tiredness diminished _sig- nificantly with time __[F(1, 176) = 17.66, P< 0.0001] as did problems with activity [F(1, 176) = 34.31, » < 0.0001]. The change in activity occurred between pre- and post-measure. ‘There were no group differences on either of these variables (Table 2). Factor analysis of the body image items revealed one scale provisionally named ‘body avoidance’ (two items: ‘That others see my scar isREHABILITATION OF CANCER PATIENTS us Table 2. Physical strength and activity subscales: mean values for the SA (m= 89-91) and control group (n=95-98) ANOVA Mean values (SD) Bifects Scales(rnin~max) a Problems with: Pre Post Three months Group Time Group x Time Physical training (0-12) SA 8.601197) 7.772.223) 7.72.11) Control 7,802.20) 8120.12) 7912.14) Gain scores SA 0830.91) -0.832.27) Control 031.02) -0.012.19) 0.001 NS. NS. Physical strength (0-24) SA 11.17%6.76)— 9.08(5.48)———8.12(5.99) Controt 8.65(6.12) 8.88(5.39) —_8.03(5.26) Gain scores SA ~ 2.094.584) ~3.06¢5.71) Controt 0.2304.86) —-—0.62(5.52) 0.001 0.05 NS. ‘Tiredness (0-12) SA 5.29.20) 4.25.03) 3.68.19) Control 5.04.15) 4.35.20) 4,002.90) NS. 0.0001 NS. Activity (0-4) SA 2441.23) Laan 1.54.32) Control 2.29(1.32) 161.17) L67(L11) NS. 0.0001 NS Body avoidance (0-8) SA 2310.2) 1862.10) 1,922.25) Controt 1.68(2:38) 2002.59) 1,672.34) NS. NS 0.05 Used t0 body (0-4) SA 1.7641.16) 1e2.ts) 1.574112) Control 1970.34) 1.76123) 1.77.18) NS. NSS, NS. Body acceptance (0-4) SA 1741.31) 16x22) 1.590113) Control Lem(.48) 1si.26 155.23) NS. ONS. NS. Global health (0-4) SA 2.28.11) 1.98(1.09)——_1.60(1.26) Contrat 2.02(1.24) 2001.17) 1.7216) NS. 0.0001 NS. * Significant between-group difference independent rest, p< 0°05, uncomfortable for me’ and ‘I avoid situations where others can see my body like swimming halls and centers for physical exercise’) and two single items (‘I have got used to the changes of my body’ and ‘I accept the appearance of my body’). In the SA group, problems with avoiding others seeing their bodies or scars diminished compared with the control group, which developed more problems from pre- {0 post-measure. Thus, there was a significant groups by time interaction (F(1, 173) = 3.01, p= <0.05] (Table 2) due to the improvement in the SA group (confirmed by Scheffés test at p=0.05). None of the groups became significantly more used to their bodies nor did they accept their bodies more over time (Table 2). There was a significant group by time inter- action [F(2,174)=33.76, p=0.0001] for patients’ appraisal of having received sufficient information (Table 3). From the post-measure and onwards, patients in the SA group stated that they had received sufficient information to a much greater extent than those in the control group, as confirmed by the Tukey test at p=0.01. In addition, only the SA group improved sig- nificantly over time (Scheffé test). ‘An additional ANOVA of the information items was performed with three groups: the SA116 group, control patients with one information yn (n= 36) and the no intervention group (n= 65). The group by time interaction was sig- nificant (F(1, 173)= 16.90, p= 0.0001]. Mean values of the control/one-session groups were 3.18, post = 12.11 and 3 months = 12.68, G. BERGLUND ET AL and for the no intervention group 13.02, 12.55 and 12.84, respectively. Thus, the effect of one information session was equal to no information. The Scheffé test indicated that the SA group improved significantly while the other groups did not change. Table 3. Patients’ appraisal of information, HAD depressive and anxiety symptoms, global quality of life communication and activities at home and in the community: mean values for the SA (n groups (n = 96-98) 39-90) and control Mean values (SD) Scales(min-max) Problems with: Pre Post Effects (ANOVA) ‘Three months Group Time Group Time Information (0-12) SA 13.48(4.38) Controt 13.0744) HAD; Depressive symptoms (0-24) SA 6810.42) Control 6410.35) HAD: Anxiety symptoms (0-20) SA 7.22.29) Contrat 7.29(3.80) Quality of tite (0-8) SA 247(1.58) Control 2.58.97) Communication (0-44) SA(n= 44) Control(n Gain scores 9.27%(4.96) 11.45.13) SA 0.55(4.08) 0.26(3.02) Controt Activities at home (0-36) SA 11,2803.66) Control 11.6108.14) Activites in the ‘community (0-28) 8.65(4.50) 12.4114.79) 6.68(3.85) 7.24.37) 7.083.42) 7.17.60) 2.43(1.62) 2.48(1.85) 9.92(4.87), 11,7044.46) 12.2745) 12.07.45) 8,344.45) 12.79¢4.91) 6394.41) 6.89.63) 4.98(3.18) $.46(3.13) 2.21(1.83) 2.31(1.79) 9.61(4.90) 11.41(5.29) 0.34(3.67) = 0.08(6.45) 11.2803.66) 11.6104.14) SA 19.08(3.90) Controt 19.34(3.59) 18.29(3.90) 19343.36) 18.73(4.20) 19.16.60) * Significant between-group difference indpendent t-test, p < 0.05 ‘Table 4. Cases and non-cases of depression at baseline, post-intervention and at 3 months follow-up for the SA and control groups SA Controt Baseline Post. 3 months Baseline Post 3: months Normal level o n n n 0 80 Bordertine/severe level 29 2% % 4 3REHABILITATION OF CANCER PATIENTS The modified HAD scale: There was no signifi- cant group by time interaction with respect to depressive symptoms nor did depressive symp- toms decrease with time. However, absolute values indicate that the mean value for the control group increased during the intervention period, whereas it did not for the SA group. Computation of the proportion of patients above the cutting point shows that this is due to an increase of the proportion of patients scoring in the border- line/severe range in the control group during the intervention period (Table 4), With respect to anxiety symptoms, quality of life and communication with staff, there were no differences between groups nor were there any changes over time (Table 3). Problems with activities at home and in the community were similar in the two groups (Table 3). The former changed significantly with time [F(1, 179)=5.58, p< 0.01], but were equal at base line and at the three months follow-up. Frequency and burden of symptoms were measured. Out of a total of 40 variables (fre- quency and burden of 20 symptoms), 19 diminished with time (p < 0.05) and there were no simple between-groups differences. There was a significant groups by time interaction only with respect to frequency of sleeping problems (FC, 181) =4.24, p< 0.05]. Scheffées post hoc test revealed that sleeping problems diminished significantly by time only in the SA group (Table 5), Table 5. Mean values of symptoms grouped in six subscales, two single symptoms with a signficant Group by Time interaction and two symptoms not included in any subscale for the SA group (n = 87-97) and control groups (n= 96-101) yavalues (SD) Effects (ANOVA) Scales (min-max) Pre Post Three months Groups Time Group x Time Sleeping problems frequency (0-4) SA 117.20) 0.85(1.09) 0.76(0.97) Control 0.88(1.13)0.95(1.09) 0.86.06) NS, 0.05 os Worry (0-12) SA 3,772.86) 3,230.68) 2.85(2.69) Control 3.29.04) 3.23(2.75) 3.06(2.85) N.S. 0.008 NS Aversions (0-16) SA 1882.58) 0.64(1.38) 0.85(2.15) Control 1,692.47) 0.85(1.80) 0,700.32) NS. 0.0001 NS, Mixed symptoms A (0-20) SA 5.92.47) 5.52(4.03)4.58(3.45) Control 5540.62) 5510.88) $350.94 NS 0.005 os Mixed symptoms B (0-8) SA 1.21.89) 1,071.30) 0,921.41) Control LAGUS1)—O.8OU.11)0.76(1.08) N.S. 0.008 NS Surgery effects (0-8) SA Lald.48) 1.29064) 1,190.55) Control HOMI-S2) 0.82.21) 0,610.08) 0.01 0.05 NS. Cognitive functioning (0-8) SA 1310.47) 1.08.29) 1.120.48) NS. NS. 01 Control 0.98(1.43) 0.9711.38) 1,200.56) Sexual problems frequency (0-4) SA 0.6911.17) 0.60(0.99)0.49(1.02) NS. NS. NS. Control 0.6211.00) 0.52(0.90)_0.4040.74) Mucous membrane disturbances frequency 0-4) SA 1.09(1.27) 0.78(1.15) 0.600098) NS. 0.01 NS. Control 0.89.21) 0.704097) 0.61(1.03)118, G Table 6. Mental adjustment to canc BERGLUND ET AL anxious preoccupation, fighting spirit, fatalistic, helpless and avoidance mean values for the SA group (n= 67-69) and control groups (= 71-72) Mean values(SD) Mental adjustment Post Anxious preoccupation SA Controt Gain scores SA Controt Fighting spirit SA Controt Gain scores SA Controt Fatalistie SA Contrat Helpless SA Contrat Avoidance SA Control 20.72"(4.12) 19.15(4.10) 18.80(4.24) 17.94.71) 1.92(4.06) 1.16@2.88) 44.69°9.79) 49,346.80) s73101.s1) 43.28(10.26) 2.62(14.98) 6.06(9.15) 15,350.30) 15.4764.21) 14.09.61) 14,543.16) 8.673.058) 7.83.80) 7.84.86) 7.80(2.70) 1.40.75) 1.44(0.82) 1.1900.59), 1560.98 1 Three months ~7.04(8.82) Effects (ANOVA, ANCOVA) Groups Time 17.74.26) 17.16(4.64) 2.95(3.85) 1.99.63), 0.005 44.06(13.30) 42,30(10.87) 0.63(14.28) 6.0001 13.54.24) 14.63.71) 8.02.31) 7,512.82) 190.56) 50(0.82) “Significant between-group difference independent ‘test, p< 0.05. Factor analysis permitted a reduction of the 20 items of symptom frequency to six subscales: (1) worry (three items: anxiousness, health worry, sleeping problems); (2) aversions (four items: nausea, food aversions, smell aversions, vomit- ing); (3) mixed symptoms A (five items: fatigue, decreased stamina, joint problems, pain, infec- tions); (4) mixed symptoms B (two items: weight problems, hair loss); (5) surgery effects (two items: problems with operation scar, problems with appearance changes); and (6) cognitive effects (two items: memory problems, concen- tration problems). Because of differences in con- tent, two items were not included in the subscales, although their factor loadings were >0.45, These were sexual problems and mucous membrane dis- turbances. Both diminished significantly with time (Table 5). All symptoms except cognitive effects diminished significantly with time, There was a significant groups by time _ interaction [F(L, 171) = 3.05, p < 0.05) only with respect to mixed symptoms A. Scheffés test showed that this was due to the diminishing degree of symptoms in the SA group. However, surgery effects showed a significant group difference: the SA group had a higher degree of problems than the control group throughout (Table 5). In the MAC scale, three adjustment responses to cancer-anxious preoccupation, fighting spirit and fatalism—diminished significantly with time (Table 6). Fighting spirit showed a significant difference at baseline [¢(145) = 3.65, p < 0.001] the control group had more fighting spirit than the SA group. ANOVA of gain scores was applied and showed a significant group difference (F(1, 137) = 17.03, p = 0.0001). This was con- firmed by the Tukey test at post-measure and at three months, Fighting spirit decrease in the control group compared with the baseline, whereas the SA group improved after intervention and at 3 months had returned to the base line level (Table 6). DISCUSSION The results demonstrate several short-term effects of the group intervention on specific dependentREHABILITATION OF measures. Physical training and physical strength improved in the SA group from baseline to post- intervention compared with the control group. Thus, up to 3 months after the program, SA group participants maintained a level of physical training and strength significantly higher than before the group program. Patients’ appraisal of having received sufficient information was also strongly influenced by the program. The group program was more efficient than one information session, which did not differ from a condition with no information. The program appears to have prevented an increase of depressive symptoms seen among the controls at post-measure. This seems reasonable in view of the fact that depression is very sensitive to activity level (Beck er al. 1984) and the intervention implies, among other things, an increase. This increase was apparently ined during the weeks after group termin- ation. The correlation between problems with physical training and depression was 0.30 at base- line and 0.32 at post-intervention (p < 0.01). With respect to frequency and burden of sleeping problems, the problem level of the SA group diminished from baseline to post-intervention compared with the control group. Sleeping problems are often related to depressive symp- toms (Beck ef al, 1984). The correlation between sleep and depression at baseline was 0.34 and at post-measure 0.27, p< 0.01. Thus, the pattern is: depression, problems with activities (physical training and strength) and sleeping problems diminished in the SA group compared with the control group from pre- to post-measure. This improvement in the SA-group with respect to depression was no longer significant at 3 months, whereas the improvements of physical activity and strength and sleeping problems were maintained in the SA group. With respect to psychological responses to cancer, there was only one important difference between the groups: fighting spirit increased as an effect of the SA program in the intervention group from pre- to post-measure and then started to diminish, whereas the control group lost fighting spirit from baseline and on. This means that the intervention possibly postponed the decrease of fighting spirit in the SA group. In a study of adju- vant psychological therapy (APT) designed to improve quality of life by changing psychological responses (Greer ef al., 1991), fighting spirit increased significantly from pre- to post-measure, CANCER PATIENTS ng whereas helplessness, anxious preoccupation and fatalism decreased. In that study, a one group pre-post design was used. The MAC scale seems to be sensitive enough for discovering changes in psychological responses achieved by the “Starting again’ program. ‘Avoiding others seeing their body decreased sig- nificantly in the SA group from pre- to post- measure. Members of the SA program were given specific training in not avoiding others seeing their body and scars. At three months, this effect had started to fade An a priori hypothesis was that more and better information would lead to less anxiety and worry However, data failed to substantiate this notion A decrease of negative emotional responses may require other techniques than information (Heinrich and Schag, 1985). It may also be that anxiety and depression is maintained by other factors in spite of the fact that patients are well- informed and satisfied with the information received. The omission of some items in the HAD. scale might have influenced the outcome with respect to anxiety and depressive symptoms by decreasing the sensitivity of the scale. ‘An interesting observation is that some vari ables such as depression, body avoidance and fighting spirit improved in the SA group as a result of the program, but the difference between groups was smaller at 3-months follow-up. One reason for this could be that the program needed special maintenance training and as far as it does not, a decrease of the effect with time would be expected. Other variables such as physical strength, physical training and patient's appraisal of having received sufficient information did not show a decreasing trend at the 3-month follow-up. ‘The methodological advantages of the present study were: randomized design; a substantial number of participants; an acceptable drop-out rate; and the use of a repeated measures statistical analysis. This, in conjunction with the reported results supports the hypothesis that the SA program has influenced participants positively The randomization procedure did not achieve groups equal at baseline with respect to physical training, physical strength and anxious preoccu- pation. When a great number of dependent vari- ables is used, this can be expected to happen by chance. When it occurs, it is important to use a statistical method compensating for the initial differences as does gain score analysis. An alternative way to avoid initial differences would120 6. have been to match subjects on the dependent variables before randomization (Kazdin, 1980). ‘The number of dependent variables prohibited that strategy in the present study. Our results are in agreement with the outcome reported for the ‘I can cope’ program (Johnson, 1985). Both programs show a substantial short- term effect of a structured educative rehabilitation program, although the dependent measures differ between studies. The effect of information agrees with the results of a non-randomized study by Heinrich and Schag (1985), in which they found that patients’ knowledge improves with time and can improve even more with an information program. The long-term effects of general educative reha- bilitation programmes for cancer patients are completely unknown. Is it possible to achieve lasting improvement or even prevention of psychosocial problems through a limited struc- tured intervention? This issue will be addressed in future program evaluations. ACKNOWLEDGEMENTS This research was supported by a grant from the Swedish Cancer Foundation. REFERENCES Beck, A. T., Rush, A. J., Shaw, B. F. and Emery, G. (1984) Cognitive Therapy of Depression. Guilford Press, New York, |, G., Bolund, C., Fornander, L-E. and Sjodén, P-O. (1991) Late effects of adj vant chemotherapy and postoperative radiotherapy on quality of life among breast cancer patients. Eur. J. Cancer 27, 1075-1081 Berglund, G.,” Gustafsson, U-L., Bolund, C. and Sjodén’ P-O. (1993) Starting again~a comparison study of a group rehabilitation program for cancer patients. Acta Oncol., 32, 1521 Blake, S. M. (1983) Group psychotherapy with breast cancer patients: a controlled trial. Unpublished ‘master’s thesis: Department of Psychiatry, University of Manchester. Bloom, J. R., Ross, R. 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Scand., 67, 361-370.Copyright of Psycho-Oncology is the property of John Wiley & Sons Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.