McDermott 2017.
| Study characteristics | ||
| Methods | Study design: RCT Study location: Northern Ireland Inclusion criteria: 1. Dukes A‐C colorectal cancer patients at least 6 weeks post any type anticancer treatment, as identified by the colorectal oncologic and surgical teams. 2. males and females over 18 years of age 3. physically able to undertake the intervention 4. ambulatory and without use of a walking aid Exclusion criteria: 1. still undergoing and/or scheduled for further anti‐cancer treatment 2. any presence of cognitive impairment 3. pregnant or possibility of being pregnant 4. known comorbidities which would severely impact upon physical functioning or nutritional status 5. already meeting the current recommended physical activity guidelines 6. unable to understand and communicate in written and oral English |
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| Participants | Number randomised: 23; 11 control; 12 intervention Baseline imbalances: mean weight and hip circumference, FACT‐C and FACIT‐F results were significantly higher in the intervention group. Fatigue scores were significantly lower in the intervention group Withdrawals and exclusions: 3 dropouts before week 12 (2 control; 1 intervention), 1 further dropout in intervention group at week 24 Age, mean (SD): total 63 (9) years; control 62.6 (9.1) intervention 63.6 (9.5) Gender n (%): Male; 6 (54.5%) control; 10 (83.3%) intervention Female; 5 (45.5%) control; 2 (16.7%) intervention Ethnicity: not reported Comorbidities: not reported SES (employment): Professional: 5 (45.5%) control; 5 (41.6%) intervention Managerial: 0 control; 3 (25%) intervention Clerical; 1 (9%) control; 2 (16.7%) intervention Manual; 5 (45.5%) control; 2 (16.7%) intervention Cancer type: colorectal Colon; 9 (81.8%) control; 8 (66.7%) intervention Rectal; 2 (18.2%) control; 4 (33.3%) intervention Colorectal cancer stage: 1a: 0 control; 1 (8.3%) intervention 2a/2b: 6 (54.5%) control; 7 (58.3%) intervention 3a/3b/3c: 5 (45.5%) control; 4 (33.3%) intervention Type of treatment: Surgery only: 1 (18.2%) control; 4 (33.3%) intervention Surgery and chemotherapy; 8 (72.7%) control; 6 (50%) intervention Radio/chemo and surgery: 1 (9.1%) control; 2 (16.7%) intervention Receiving or finished treatment: finished (at least 6 weeks post‐treatment) Time beyond treatment: an average of 24 months post‐treatment (25 (17) months in control group; 23 (19) months in the intervention group) Time since diagnosis: not reported |
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| Interventions | Physical activity description: Frequency: not reported Intensity: moderate‐intensity Time: not reported Type: walking and strengthening intervention Volume: not reported Progression: aim to reach at least 150 minutes a week of moderate‐intensity aerobic activity and strengthening goal of 3 sets of 8‐15 repetitions, 2‐3 days a week Length of programme: 12 weeks Control group: usual care; participants will receive the intervention information on their last visit Setting: home based Supervised or self‐directed: self‐directed with weekly telephone calls Co‐interventions: none |
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| Outcomes | 1. Feasibility
2. Levels of physical activity (accelerometer)
3. Cardiovascular endurance (6‐minute walk test)
4. Lower limb strength (timed sit to stand)
5. Quality of life (FACT‐C, EQ5D‐3L, PANAS)
6. Demographics
7. Anthropometric tests (BMI, height, weight, hip and waist measurements)
8. Biological markers (venous and capillary blood samples)
9. Fatigue (MFSI‐SF) Time points measured: baseline 12, 24 weeks Time points reported: baseline 12, 24 weeks Adverse events: not reported |
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| Notes | Funding source: University of Ulster | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A random numbers table was used |
| Allocation concealment (selection bias) | Low risk | Numbered concealed envelopes were used |
| 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 | High risk | Researcher carrying out the outcome measures was aware of the participants group allocation |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition (17%) and exclusions were reported with reasons. ITT analysis conducted |
| Selective reporting (reporting bias) | Low risk | Outcomes reported are consistent with outcomes to be reported in clinical trial register |
| Other bias | Low risk | Baseline imbalances present, however described appropriate allocation concealment |