Fann 2017.
Study characteristics | ||
Methods | Randomised trial, USA | |
Participants | Adult patients starting cancer therapy | |
Interventions | Adult patients starting cancer therapy were randomised to receive usual education about symptoms and quality of life (SxQOL) topics (control) or usual education plus self‐care instruction for SxQOL issues, communication coaching, and the opportunity to track SxQOL between clinic visits (intervention). Clinicians received summaries of participant reports at each time point in both groups. Intervention features Multiple complex feedback (multiple PROMs at multiple times) PROM(s) used as intervention: PHQ‐9=Patient Health Questionnaire‐9, EF=QLQ‐C30 emotional functioning, HSCT=hematopoietic stem cell transplant, RF=QLQ‐C30 role functioning, SF=QLQ‐C30 social functioning Constructs measured: Health related Quality of Life, Symptoms, Functioning Instrument categories/domains: Domain/Disease specific (mental health) Administration features Where PROMs administered: Non‐clinical setting How administered: Self‐administered Format of PROMs questionnaire(s): Electronic Feedback features Format of PROMs feedback: Electronic How often information fed back: PROMs were administered before treatment (T1), 3–6 weeks after starting treatment (T2), 2 weeks later (T3), and 2–4 weeks after treatment ended or at the next restaging visit for participants who continued to receive treatment (T4). Who information fed back to: Clinicians, Patients Information fed back: Scores, Previous scores, Interpretation guidance, Management recommendations |
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Outcomes | Secondary analysis of psychosocial outcomes of the ESRA‐C‐II study by examining the effects of the intervention on depression and on social, emotional and role functioning. | |
Notes | The study was funded by the National Institute of Nursing Research R01 NR008726. The study recruited from October 2008 until December 2013. The authors reported no conflicts of interest. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated. |
Allocation concealment (selection bias) | Unclear risk | No information provided about who did allocations. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to nature of intervention not possible to blind patients and personnel. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Due to nature of the intervention blinding of outcomes not possible: PROM used for feedback also used to assess outcome, patients were aware they received the intervention. |
Baseline outcome measurements similar | Low risk | Mean scores were similar between groups. |
Baseline characteristics similar | Low risk | No significant differences in characteristics. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Original paper stated that incomplete data was removed. |
Was study protected against contamination | Low risk | Controls did not do intervention or had access to intervention system. |
Selective reporting (reporting bias) | Low risk | Main outcome reported in the results. |