Park 2016.

Methods	Design: randomised controlled trial Country: Berlin Accrual dates: September 2011 to October 2013 Trial Reg: NCT01819324
Participants	Number randomised: 173 Invitation letter 1397, ClinicalTrials.gov 16, main hospital 866, returned to sender 124, received 177 (excluded 4, not eligible 3, did not complete required materials 1), TTMI 57, follow‐up for 4 months 40 (lost 17), follow‐up for 7 months 43 (3 came back), SLM 58, follow‐up for 4 months 43 (lost 15), follow‐up for 7 months 41 (lost 2), control 58, follow‐up for 4 months 50 (lost 8), follow‐up for 7 months 47 (lost 3) Inclusion: first diagnosed with breast cancer in the past 1.5 years. Stage 0 to 2 breast cancer. No prior adjuvant treatment for another cancer. Can read and write English. Not participating in other health behaviour research right now Exclusion: apparently serious mental disturbance, male breast cancer survivors Gender: female Age: TTMI mean 55.73 (SD 10.91); SLM mean 57.74 (SD 10.7); UC mean 55.72 (SD 10.92) years Ethnicity: White: TTMI n = 54 (94.7%); SLM n = 56 (96.6%); UC n = 53 (93.0%) African American: TTMI n = 1 (1.8%); SLM n = 1 (1.7%); UC n = 2 (3.5%) Hispanics: TTMI n = 1 (1.8%); SLM n = 0; UC n = 1 (1.8%) Other: TTMI n = 1 (1.8%); SLM n = 1 (1.7%); UC n = 1 (1.8%) Type of cancer: breast Therapy previously received for cancer: Current cancer treatment No: TTMI n = 35 (64.8%); SLM n = 38 (70.4%); UC n = 33 (58.9%) Yes: TTMI n = 19 (35.2%); SLM n = 16 (29.6%); UC n = 23 (41.1%) Cancer stage: NR Baseline physical activity: exercise time (minutes): NR Education: Less than high school: TTMI n = 0; SLM n = 1 (1.7%); UC n = 0 High school/GED 6: TTMI n = 7 (10.5%); SLM (12.1%); UC n = 8 (14.0%) Some college: TTMI n = 11 (19.3%); SLM n = 9 (15.5%); UC n = 8 (14.0%) 2‐year college degree (Associate's): TTMI n = 7 (12.3%); SLM n = 4 (6.9%); UC n = 5 (8.8%) 4‐year college degree (BA/BS): TTMI n = 17 (29.8%); SLM n = 23 (39.7%); UC n = 20 (35.1%) Graduate degree (MA, PhD): TTMI n = 16 (28.1%); SLM n = 13 (22.4%); UC n = 12 (21.0%) Professional degree (MD, JD): TTMI n = 0; SLM n = 1 (1.7%); UC n = 4 (7.0%)
Interventions	Comparison: mail‐based teachable moment materials vs mail‐based standard lifestyle management vs usual care Experimental: targeting the teachable moment: receiving targeting the teachable moment intervention materials (focused on health behaviours and issues specific to breast cancer survivors) every other week for 4 months Active comparator: standardised lifestyle management: receiving standardised lifestyle management materials (focused mostly on health behaviours) every other week for 4 months No intervention: usual care: receiving SLM materials at the end of 7 months
Outcomes	Primary outcome measures: Changes in eating habits measured by the National Cancer Institute Quick Food Scan Diet habits (amount of fat and fruit/vegetable uptake) Changes in physical activity measured by the Paffenbarger physical activity questionnaire Frequency and amount of time for physical exercise Secondary outcome measures: Changes in coping strategies measured by the Brief COPE Coping strategies (e.g. problem‐focused coping, emotional approach coping) Changes in self‐efficacy measured by the general self‐efficacy questionnaire General sense of perceived self‐efficacy Changes in social support measured by the Interpersonal Support Evaluation List (ISEL) Social support Changes in life meaning measured by the Meaning in Life Questionnaire (MLQ) Presence of meaning and search for meaning Duration of follow‐up: 7 months
Notes	Funding: National Cancer Institute
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants completed baseline questionnaires (T1) and then were randomly assigned (using a blocked design to ensure equal numbers of participants in each group) to 1 of 3 groups
Allocation concealment (selection bias)	Unclear risk	Participants completed baseline questionnaires (T1) and then were randomly assigned (using a blocked design to ensure equal numbers of participants in each group) to 1 of 3 groups
Blinding of participants and personnel (performance bias) Objective outcomes	Unclear risk	No objective outcome measures
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Participants and personnel not blinded
Blinding of outcome assessment (detection bias) Objective outcomes	Unclear risk	No objective outcome measures
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Patient self‐report
Incomplete outcome data (attrition bias) Objective	Unclear risk	No objective outcome measures
Incomplete outcome data (attrition bias) Subjective	High risk	Dropout from intervention groups: targeting the teachable moment 25% and standard lifestyle management 30% vs 19% control
Selective reporting (reporting bias)	Unclear risk	Protocol could not be located; insufficient information to make a judgement
Other bias	Unclear risk	Insufficient information to make a judgement