Helmes 2006.

Study characteristics
Methods	RCT
Participants	340 women from a healthcare network in Washington state, USA were randomised. Women were aged 18‐64, with no personal history of breast/ovarian cancer, who had not previously received genetic counselling or genetic testing. Other eligibility criteria included living within 60 miles of the research centre, ability to speak and write in English, having a telephone at home and being covered by health insurance. The sample was at population risk of cancer
Interventions	In‐person versus telephone breast cancer risk genetic counselling by a certified genetic counsellor compared with a delayed counselling control group
Outcomes	Cancer worry (measured by the cancer worry scale (Lerman 1991a)) Risk perception (single‐item measure on a scale of 1‐100) Breast health intention scale assessed by averaging responses to three measures: Intentions to obtain mammograms; clinical breast examination; breast self‐examination Interest in genetic testing (measured using 4 items, from which a single testing intention score was calculated) Acceptability of counselling assessed with intervention participants
Notes	Recruitment described further in Helmes 2000. The same counsellor was used for the entire study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomised using a computer‐generated list of numbers Comment: Information from personal communication with author
Allocation concealment (selection bias)	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	98.5% of randomised participants completed 3‐month follow‐up assessment. "We analyzed the data using the intention to treat principle, including all randomized women."
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes reported