Hagopian 1990.

Methods	DETAILS OF STUDY AIM OF INTERVENTION: it was expected that patients who received a weekly telephone call would have less anxiety, less severe side effects, use more helpful self‐care strategies and cope better than patients who did not receive TFU. AIM OF STUDY: to investigate the effects that a weekly telephone call intervention had on patients' well‐being. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: potential subjects from the physician's practice and meeting the study criteria were identified by the physician nurse team. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: undergoing radiation therapy for cure /able to communicate by telephone. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: not specified. INFORMED CONSENT OBTAINED? unclear. ETHICAL APPROVAL? unclear. FUNDING: yes. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: unclear. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: not specified. METHOD OF CONCEALMENT OF ALLOCATION: not specified. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: no. INTENTION TO TREAT ANALYSIS: not stated. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: yes. STATISTICAL METHODS AND THEIR APPROPRIATENESS: t‐test/anova. CONSUMER INVOLVEMENT: not stated.
Participants	DESCRIPTION: oncology patients GEOGRAPHIC LOCATION: USA. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 55. RANDOMISED TO INTERVENTION: 27. RANDOMISED TO CONTROL: 28 ‐ ‐ . INCLUDED IN ANALYSIS INTERVENTION GROUP: 27. INCLUDED IN ANALYSIS CONTROL GROUP: 28 ‐ ‐ . AGE: RANGE OR MEAN (SD): 58. GENDER (% MALE): 40. ETHNICITY: PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: cancer patients receiving radiotherapy (34% breast cancer; plus 7 other types of cancer). OTHER HEALTH PROBLEM/S: unclear. TREATMENT RECEIVED/RECEIVING: radiotherapy. OTHER SOCIAL/DEMOGRAPHIC DETAILS:
Interventions	DETAILS OF INTERVENTION: Experimental patients received usual care ; in addition they received a weekly telephone call by NURSE to further assess problems and reinforce teaching. The weekly telephone calls continued until the first follow‐up visit, which usually occurred 1 month after treatment was completed/ DETAILS OF CONTROL: usual care consisting of weekly on‐treatment visits with both the physician and nurse during the course of the treatment, usually lasting 6 weeks. CO‐INTERVENTION? yes. DETAILS OF CO‐INTERVENTIONS: usual care consisting of weekly on‐treatment visits with both the physician and nurse during the course of the treatment, usually lasting 6 weeks. DELIVERY OF INTERVENTION Frequency: 4. First time at day 1 week after discharge. Period: 4 weeks. PROVIDERS: nurse. INTERVENTION QUALITY: coincides with weekly treatment and counseling by nurse and physician. FIDELITY/INTEGRITY: unclear.
Outcomes	NUMBER OF OUTCOMES: 4 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, ..): Anxiety / state‐anxiety inventory (Spielberger 1983) / yes / telephone interview / 1, 2, 3, 4 and 6 weeks after discharge. Coping / self‐developed / adapted from the chronicity Impact and Coping instrument (Hymovich, 1984) / telephone interview / 1, 2, 3, 4 and 6 weeks after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): Selfcare / self‐developed / unclear / telephone interview / 1, 2, 3, 4 and 6 weeks after discharge C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): Side‐effects / self‐developed: side‐effects profile / unclear / telephone interview / 1, 2, 3, 4 and 6 weeks after discharge. D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..):
Notes	·CHANGES IN TRIAL PROTOCOL ·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?	Unclear risk	B ‐ Unclear