Samarel 2002.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: to reduce worry, mood disturbance and enhance well‐being and quality of relationship. AIM OF STUDY: the purpose of this study was to examine the effects of a 13‐month, 3 phase intervention, comparing an experimental group receiving combined individual telephone and in‐person group social support and education treatment with a control group receiving telephone only individual support and education treatment and a control group receiving one time mailed educational information treatment on cancer‐related worry, well‐being, mood disturbance, loneliness and the quality of relationship with a significant other among women newly diagnosed with early stage breast cancer. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: Women were recruited through letters distributed at physician's offices, hospitals and the American Cancer Society Reach to Recover program. Because letters were distributed by personnel at each site, the number of women reached is not known. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: English speaking/ had surgery for nonmetastatic breast cancer within 4 weeks prior to beginning their participation in the study, had no previous cancer diagnosis, no other major medical problems. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not specified. INFORMED CONSENT OBTAINED? yes. ETHICAL APPROVAL? unclear. FUNDING: yes. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: adequate. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: Using a permuted block design for randomization, when successive cohorts of 4‐8 women had been recruited, the entire cohort was randomly assigned to one of the three treatment groups using the sealed opaque envelope technique. When the next cohort was recruited, that cohort was assigned to one of the two remaining study treatment groups, using the two remaining sealed opaque envelopes. The next cohort was assigned to the remaining study treatment group, after which the process started again. Random assignment was repeated in this manner until the full sample was recruited and assigned. METHOD OF CONCEALMENT OF ALLOCATION: sealed opaque envelopes. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: no. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: no. STATISTICAL METHODS AND THEIR APPROPRIATENESS: manova/ anova/kruskall‐wallis/ mann‐whitney U. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION: oncology patients / surgery patients. GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 183. RANDOMISED TO INTERVENTION: 68. RANDOMISED TO CONTROL: 34 ‐ 60. INCLUDED IN ANALYSIS INTERVENTION GROUP: 48. INCLUDED IN ANALYSIS CONTROL GROUP: 34 ‐ 60. AGE: RANGE OR MEAN (SD): 54 (10.8). GENDER (% MALE): 0. ETHNICITY: 89% white. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: breast cancer. OTHER HEALTH PROBLEM/S: not specified. TREATMENT RECEIVED/RECEIVING: lumpectomy (42%), mastectomy (57), chemotherapy (44%), radiation therapy (26%). OTHER SOCIAL/DEMOGRAPHIC DETAILS: 61% married, 43% high school.
Interventions	DETAILS OF INTERVENTION: 3 groups: telephone only, telephone and in‐person group social support,and group 3 one time education by mailing. Women in (for this review experimental group) experienced a less intense form of the focal stimulus by receiving social support and education only by telephone in all 3 phases of the study (see control group 1). the intervention was based on Roy's adaptation model. The individual telephone social support and education were provided by either oncology nurse clinicians or social workers, who were trained by the investigators. Specially developed guides were used during the intervention. Logs of the phone contacts were made, that were periodically reviewed. DETAILS OF CONTROL: This group received the most intense intervention in the form of the focal stimulus of social support and education by receiving combined individual telephone and in‐person group social support and education, which was provided in 3 phases over 13 months. The treatment was designed to provide more intense support during the times of peak need. More specifically weekly phone contacts in first 3 months, weekly in‐person social support in next two months and twice‐monthly phone contacts in next 8 months. Control group 2 received usual care in first 3 months, and one‐time mailing in month 4. CO‐INTERVENTION? no. DETAILS OF CO‐INTERVENTIONS: DELIVERY OF INTERVENTION Frequency: 32. First time at day between week 2 and 4 after discharge. Period: 13 months. PROVIDERS: nurse/social worker. INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: good.
Outcomes	NUMBER OF OUTCOMES: 7 OUTCOME / TOOL / TOOL VALIDATED / METHOD OF ASSESSMENT / TIME OF ASSESSMENT A.Psycho‐social health of patients (uncertainty, anxiety, informational needs, mood, coping, quality of life, social activity, ..): Satisfaction / patient satisfaction questionnaire (Shortell 2000) / yes / telephone interview / 1 and 5 weeks after discharge. Mental status / SF‐36 (Ware, 1992) / yes / telephone interview / 1 and 5 weeks after discharge. Social functioning / SF‐36 (Ware, 1992) / yes / telephone interview / 1 and 5 weeks after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): Physical functioning / SF‐36 (Ware, 1992) / yes / telephone interview / 1 and 5 weeks after discharge. Symptom distress / Memorial symptom assessment scale (Portenoy 1994) / yes / telephone interview / 1 and 5 weeks after discharge. C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..): Readmission / self‐developed / no / telephone interview / 1 and 5 weeks after discharge. ED‐visits / self‐developed / no / telephone interview / 1 and 5 weeks after discharge.
Notes	·CHANGES IN TRIAL PROTOCOL NOTE: since intervention group and control group 1 receive the same intervention during first 3 months and they only start differing after this point, these groups can be combined for this review into 1 intervention group and compared to control group 2 (usual care). ·CONTACT WITH AUTHOR ·POWER CALCULATION? yes. ·RECORD IF THE STUDY WAS TRANSLATED FROM A LANGUAGE OTHER THAN ENGLISH. ·RECORD IF THE STUDY WAS A DUPLICATE PUBLICATION.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate