Munro 1994.
Methods | DETAILS OF STUDY AIM OF INTERVENTION: to enhance support. AIM OF STUDY: the hypothesis tested was that routine contact by telephone might significantly improve the adequacy of support for patients during the potentially stressful period between completing radiotherapy and the first follow‐up visit. STUDY DESIGN: CCT. METHODS OF RECRUITMENT OF PARTICIPANTS: consecutive unselected outpatients attending for radiotherapy. INCLUSION CRITERIA FOR PARTICIPATION IN STUDY: radiotherapy patients. EXCLUSION CRITERIA FOR PARTICIPATION IN STUDY: did not understand English/ not having a telephone/ HIV‐related malignancy/ less than 5 dose of radiotherapy/ inhospital patients. INFORMED CONSENT OBTAINED? unclear. ETHICAL APPROVAL? unclear. FUNDING: unclear. ASSESSMENT OF STUDY QUALITY ALLOCATION CONCEALMENT: unclear. EPOC‐ QUALITY CRITERIA 2002: C.high risk of bias. METHOD OF GENERATING RANDOMISATION SCHEDULE: unclear. METHOD OF CONCEALMENT OF ALLOCATION: unclear. BLINDING: ·PARTICIPANTS: no. ·PROVIDER/S: no. ·OUTCOME ASSESSOR/S: no. INTENTION TO TREAT ANALYSIS: yes. BASELINE COMPARABILITY OF INTERVENTION AND CONTROL GROUPS: not stated. STATISTICAL METHODS AND THEIR APPROPRIATENESS: chi‐square. CONSUMER INVOLVEMENT: not stated. |
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Participants | DESCRIPTION: oncology patients. GEOGRAPHIC LOCATION: UK. SETTING: discharged home from an acute care setting. NUMBER OF PARTICIPANTS: ELIGIBLE: 100. RANDOMISED TO INTERVENTION: 49. RANDOMISED TO CONTROL: 39. INCLUDED IN ANALYSIS INTERVENTION GROUP: 33. INCLUDED IN ANALYSIS CONTROL GROUP: 39. AGE: RANGE OR MEAN (SD): 30 to 88. GENDER (% MALE): 42. ETHNICITY: not stated. PRINCIPAL HEALTH PROBLEM OR DIAGNOSIS: radiotherapy for cancer (breast 43%, lung, 31%,..). OTHER HEALTH PROBLEM/S: unclear. TREATMENT RECEIVED/RECEIVING: OTHER SOCIAL/DEMOGRAPHIC DETAILS: |
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Interventions | DETAILS OF INTERVENTION: Telephone contact comprised telephone calls to the patient on day 4, 8, 14 and 18 after completing radiotherapy; the telephone calls were made by a member of staff (radiographer, nurse, or doctor who was known to the patient). The calls were semistructured, the questions to be asked being: 'how are you feeling?', 'are you having any problems?', 'have you any further side‐effects from treatment?', 'do you need to make an appointment ..?'. patients were asked if they had any additional worries or concerns. wherever possible action was taken. DETAILS OF CONTROL: all patients were seen once a week in the clinic by a doctor during the radiotherapy treatment. Additional advice and support was given, where necessary, by radiographers and nurses. In the usual care group no attempt was made to contact the patients between completing treatment and the first follow‐up visit. If patients telephoned the department for advice or support this was provided. CO‐INTERVENTION? yes. DETAILS OF CO‐INTERVENTIONS: see control intervention. DELIVERY OF INTERVENTION Frequency: 4. First time at day 4 after discharge. Period: 3 weeks. PROVIDERS: mixed (nurse, radiographer, doctor). INTERVENTION QUALITY: unclear. FIDELITY/INTEGRITY: unclear. |
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Outcomes | NUMBER OF OUTCOMES: 1 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 (adequacy of support) / self‐developed / no / questionnaire / 4 weeks after discharge. B.Physical health of patients (eg. functional status, self‐care, self‐efficacy, independence, ..): C.Other consumer oriented outcomes (eg. treatment adherence, knowledge, adverse events, ..): D. Health service delivery oriented outcomes (eg. hospital readmission, health services utilization, ..): |
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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. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |