Mosher 2016.
Study characteristics | ||
Methods |
Setting: Indiana, USA Recruitment: eligible participants were diagnosed with small cell or non‐small cell lung cancer; had at least 1 symptom of moderate severity, defined by validated cutoff points for depressive symptoms, anxiety, pain, vitality, or breathlessness; were fluent in English; and had a consenting carer Randomisation: RCT; randomisation by a person not involved with study delivery using an SAS procedure |
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Participants | 106 dyads comprising a man/woman with symptomatic lung cancer and his/her carer | |
Interventions |
Intervention: based on Social‐Cognitive Theory. Participants took part in four 45‐minute telephone symptom management (TSM) sessions. Both dyad members participated simultaneously through speaker phone. Received instruction in symptom management strategies. Mailed handouts detailing major points discussed during sessions, along with home practice assignments and digital media with instructions for relaxation exercises. Primary goal of intervention was to teach participants and carers evidence‐based cognitive‐behavioural and emotion‐focused strategies for managing symptoms. All sessions had dual focus on participant and carer concerns Control group: four 45‐minute telephone sessions delivered to dyads by speaker phone aimed at directing participants to resources for practical health information and psychosocial services Interventionist: clinical social workers trained by a PhD psychologist |
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Outcomes |
Methods for assessing outcomes:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Generated by an individual independent from the study. Stratified by participant gender and performance status |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding (performance bias and detection bias) All outcomes | Low risk | Research assistants blind to study condition conducted all assignments by telephone |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss to follow‐up over 20%; reasons similar between groups |
Selective reporting (reporting bias) | Low risk | Balanced reporting for all measures |
Other bias | Low risk | The trial appears to be free of other problems that could put it at high risk of bias |