Pinto 2013.
| Study characteristics | ||
| Methods | Study design: RCT Study location: USA Inclusion criteria: 1. sedentary adults 2. stage 1‐3 colorectal cancer 3. finished treatment surgery and/or adjuvant therapy 4. less than 5 years postdiagnosis 5. English speaking 6. access to a telephone 7. CVD or diabetes with consent Exclusion criteria: 1. prior history of cancer 2. medical or current psychiatric illness (e.g. orthopaedic problems) that could make compliance with the study protocol difficult or unsafe |
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| Participants | Number randomised: 46; 20 to physical activity group, 26 to control group Baseline imbalances: more people in employment in the control group Withdrawals and exclusions: 4 withdrew; 1 in physical activity group, 3 in control group Age: 57.3 years (SD 9.7); intervention 55.6 (8.24) control 59.5 (11.2) Gender: male and female (57%) Ethnicity: majority white Comorbidities: not reported SES: majority attended college and had a median household income of USD 60,000 Cancer type: colorectal cancer; 57% colon cancer, 43% rectal cancer Cancer stage: stage I‐III Type of treatment: 100% surgery or surgery with adjuvant therapy 20/46 radiotherapy; 38/46 chemotherapy Receiving or finished treatment: finished Time beyond treatment: < 5 years since completion of treatment Time since diagnosis: mean 2.99 years since diagnosis |
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| Interventions |
Physical activity description: Frequency: encouraged 10 minutes at least 2 days per week for three weeks, goals were increased over the 12 weeks to 30 minutes a day, 5 days per week Intensity: moderate 64% to 76% estimated heart rate max Type: e.g. brisk walking, biking, home‐based exercise equipment Length of intervention: 12 weeks Control group: contact control group (received weekly calls to match frequency of contact with physical activity group and survivorship tip sheets) Setting: home based Supervised or self‐directed: self‐directed Co‐interventions: none |
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| Outcomes | 1. Levels of physical activity (7‐day recall, Community Healthy Activities Model Program for Seniors, accelerometry),
2. Movement to action/maintenance stage of motivational
readiness,
3. Submaximal aerobic fitness (Treadwalk test)
4. Psychological outcomes (FACT‐C)
5. Fatigue (FACT‐F)
6. Anthropometric measurements (height, weight, BMI) Time points measured: baseline, 3, 6 and 12 months Time points reported: Adverse events: not reported |
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| Notes | Funding source: National Cancer Institute | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participants and personnel due to the nature of the intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessments conducted by a staff member who was blinded to the participants' group assignments |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for missing outcome data were described (9% attrition) |
| Selective reporting (reporting bias) | Low risk | Outcomes reported are consistent with study protocol |
| Other bias | High risk | Due to baseline imbalances alongside unclear allocation concealment |