Schofield 2013.

Methods	RCT ‐ with intervention group (IG) and control group (CG)
Participants	Adult patients with inoperable lung cancer Country: Australia Age: IG: mean 62.3 years (9.2 SD); CG: mean 63.8 years (11.4 SD) Sex: IG: 43.6% female; CG: 35.8% female Inclusion criteria diagnosis of inoperable lung or pleural (including mesothelioma) cancer scheduled to receive palliative external beam radiotherapy, palliative chemotherapy, or radical radiotherapy and chemotherapy able to understand English Exclusion criteria psychiatric disorder or serious cognitive impairment ECOG performance status (18) score ≥ 3 or 2 months or less since a previous treatment regimen N randomised: N = 108; IG: n = 55; CG: n = 53 N in analysis: N = 108; IG: n = 55; CG: n = 53
Interventions	Content of screen:CARE NEEDS: The 38‐item Needs Assessment for Advanced Lung Cancer Patients with subscales: medical communication/information, psychological/emotional, daily living, financial, symptoms, and social Interventionist: Self‐completion of the needs assessment, but a trained cancer health professional needed for the results discussion Intervention procedure:SI with co‐intervention to use screening results: 2 sessions (treatment commencement and completion): self‐completed needs assessment + intervention with active listening, self‐care education and communication of unmet psychosocial and symptom needs to the multidisciplinary team for management and referral Conditions for implementation a system/person is needed to deliver and collect questionnaires and to control data management training of a cancer health professional in the intervention‐action; development of consultation materials: 6 standardised, manualised modules with a take‐home self‐care leaflet to address unmet needs reported by participants during consultations (‘Communicating With Your Health Professional’, ‘Communicating With Your Family and Friends’, ‘Dealing With Emotional Distress’, ‘Dealing With Sleeplessness’, ‘Dealing With Breathlessness’, and ‘Goals for the Future’) Comparative condition: Usual care group Length of follow‐up: From treatment commencement to 12 weeks' post‐treatment completion: length depends on length of treatment
Outcomes	Primary outcomes: unmet needs: Needs Assessment for Advanced Lung Cancer Patients psychological morbidity (HADS) distress (DT) HRQoL (EORTC QLQ‐C30) Secondary outcomes: / Outcome time points: baseline; 8‐week post‐treatment completion; 12‐week post‐treatment completion
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated, weighted‐biased coin method, including stratification according to scheduled treatment (palliative chemotherapy, radical radiotherapy, and palliative radiotherapy)
Allocation concealment (selection bias)	Unclear risk	Unclear which method was used to conceal the allocation of physicians to conditions
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding: very involved multidisciplinary team, IG and CG may not have been sufficiently different. Tape‐recorded consultations run by 2 individuals not involved in providing usual care to ensure that there was no contamination between conditions
Blinding of outcome assessment (detection bias) All outcomes	Low risk	All outcomes collected with self‐report questionnaires, no extra person for outcome assessment aware of condition allocation
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropout from baseline to 12 weeks' post‐treatment completion +/− 27%; missing intervention consultations and/or outcome assessment due to scheduling issues, withdrawal, worsened health, death
Selective reporting (reporting bias)	Low risk	Adequate
Other bias	Low risk	/