Girgis 2009.

Study characteristics
Methods	Setting: New South Wales, Australia Recruitment: eligible participants were 18 years of age or older, had non‐localised breast or colorectal cancer, were diagnosed within the last 6 months, resided in New South Wales province at diagnosis, were able to complete study measures in English, and were physically and mentally capable of study participation. Potential participants were identified by the New South Wales Central Cancer Registry, and eligibility was confirmed by participants' treating physicians. Eligible individuals were sent a letter from the CCR seeking consent to receive study information from the research team. If a signed consent form was returned, the participant was contacted by telephone to complete baseline measures Randomisation: parallel factorial RCT
Participants	356 men and women aged 18 years or older with non‐localised breast or colorectal cancer
Interventions	Intervention: based on the notion of providing feedback for patient‐reported outcomes (PROs) to clinicians to improve supportive care for cancer patients. Participants completed 3 computer‐assisted telephone interviews at baseline and at 3 and 6 months. Patient‐reported outcomes collected during these interviews were summarised onto a feedback sheet by a specially developed computer programme, which identified issues of concern (e.g. severe symptoms). In the TCW arm, feedback sheets were forwarded to telephone care workers (TCWs), who then telephoned participants to discuss reported issues of concern and used a modified version of the Cancer Helpline database to refer participants to appropriate resources/services consistent with recommended feedback sheet strategies. TCWs also followed up with participants at 6‐week intervals to assess coping. In the oncologist/GP arm, 2 hard copies of feedback sheets were mailed to participants’ nominated oncologists and GPs for discussion at their next appointments. Clinicians were asked to keep 1 feedback sheet for their records and to return the second, which indicated which issues of concern were discussed and whether any actions were taken Control group: usual care (not described) Interventionist: oncology nurses with telephone counselling training
Outcomes	Psychological symptoms ‐ anxiety, depression Fatigue Physical symptoms ‐ nausea, vomiting Impact on quality of life/functioning ‐ quality of life, perceived needs, communication with health care professionals Methods for assessing outcomes: Hospital Anxiety and Depression Scale European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, version 3 Supportive Needs Survey ‐ Short Form Needs Assessment for Advanced Cancer Patient Questionnaire
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random assignment to one of the three study groups, by using a computer‐generated algorithm, occurred at completion of the baseline CATI and included stratification by sex and tumour type
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding (performance bias and detection bias) All outcomes	High risk	Owing to the nature of the intervention, participants and personnel were not blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow‐up < 20%; similar reasons between groups
Selective reporting (reporting bias)	Low risk	There appears to be no selective reporting on outcomes
Other bias	Low risk	The trial appears to be free of other problems that could put it at high risk of bias