Kanera 2017.
Methods |
Design: randomised controlled trial Country: Netherlands Accrual dates: November 2013 to June 2014 Trial Reg: Dutch Trial Register NTR3375 |
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Participants |
Number randomised: 518 1303 eligible, 785 no participation (decline before consent 100, not meeting inclusion criteria 5, computer literacy 10, unknown 670), 231 allocation to control group (no consent 7, not meeting inclusion criteria 2, baseline incomplete 13), 221 follow‐up for 6 months (lost 10), 212 follow‐up for 12 months (lost 19), 231 allocation to intervention group (no consent 6, not meeting inclusion criteria 15, baseline incomplete 13), 188 follow‐up for 6 months (lost 43), 169 follow‐up for 12 months (lost 62) Inclusion: 18 years of age or older. Previously diagnosed with cancer. Successful completion of the main treatment period. Up to 1 year ago. Receive aftercare (e.g. preventive hormonal therapy) or medical check‐ups. No cancer during last medical check‐up. All types of cancer. No groups were excluded (on condition that the main treatment period was successfully completed). Ability to speak and read the Dutch language. Access to the web and minimal Internet experience (monthly access) Exclusion: serious medical, psychiatric, or cognitive disease that would interfere with participation Gender: female: intervention: n = 183 (79.2 %), control: n = 186 (80.5%) Age: Intervention: mean 55.6 (SD 11.5) years Control: mean 56.2 (SD 11.3) years Ethnicity: NR Type of cancer: various (breast cancer: intervention = 70%, control = 71%) Therapy previously received for cancer: Surgery, chemotherapy, radiation: intervention: n = 86 (37.2%), control: n = 108 (46.8%) Surgery, chemotherapy: intervention: n = 61 (26.4%), control = 48 (20.8%) Surgery, radiation: intervention: n = 46 (19.9%), control: n = 30 (13.0%) Other: intervention: n = 38 (16.5%), control: n = 45 (19.5%) Cancer stage: NR Baseline physical activity: Weekly days > 30 minutes PA; intervention 4.9 mean (SD 1.9); control 4.6 mean (SD 2.0) Light PA minutes p/w: intervention 1521.5 mean (SD 897.9); control 1430.2 mean (SD 897.7) Moderate PA minutes p/w: intervention 595.9 mean (SD 620.5); control 526.5 mean (SD 546.5) Vigorous PA minutes p/w: intervention 231.0 mean (SD 323.9); control 238.0 mean (SD 426.0) Education: Low: intervention n = 76 (32.9%); control n = 97 (42.0%) Medium: intervention n = 76 (32.9%); control n = 70 (30.3%) High: intervention n = 79 (34.2%); control n = 64 (27.7%) |
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Interventions |
Comparison: online intervention questionnaire vs wait‐list control Intervention: cancer survivors in the experimental group who enter the online portal receive general information on dealing with distress, obtaining social support, self‐managing disease, and optimising healthy lifestyles. They are free to fill out a questionnaire on personal needs, which will lead them to tailored advice about the mentioned topics. Also information about possible other helpful interventions and social workers is provided. Cancer survivors in the experimental group are free to enter the online portal as often as they want to Wait‐list control: provided with access to online intervention after the last measurement |
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Outcomes |
Physical activity: Self‐reported Questionnaire to Assess Health Enhancing Physical Activity – SQUASH Vegetable consumption: Dutch Standard questionnaire on Food Consumption Duration of follow‐up: 12 months |
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Notes | Funding: KWF Kankerbestrijding, Netherlands Laboratory for Lifelong Learning (NELLL) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised allocation (ratio of 1:1) was automatically performed by means of a digital randomiser after centralised registration of participants |
Allocation concealment (selection bias) | Low risk | Randomised allocation (ratio of 1:1) was automatically performed by means of a digital randomiser after centralized registration of participants |
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 | Outcome patient self‐reported |
Incomplete outcome data (attrition bias) Objective | Unclear risk | No objective outcome measures |
Incomplete outcome data (attrition bias) Subjective | High risk | High attrition rate from intervention group (62 compared to 19 in control group). ITT used |
Selective reporting (reporting bias) | Unclear risk | Primary outcomes: physical activity and fruit and vegetable consumption reported Primary outcome of well‐being not reported |
Other bias | Unclear risk | Insufficient information to permit judgement |