Oncology · Medical Literature
Effects of a Psycho-Behavioural Intervention on Cancer-Related Fatigue Among Patients With Colorectal Cancer: A Pilot Randomised Controlled Trial.
Abstract
Post-treatment colorectal cancer patients commonly experience cancer-related fatigue (CRF), yet few interventions address this concern. To examine the feasibility, acceptability, and preliminary effects of a psycho-behavioural intervention on CRF and other health outcomes in this population. A single-blinded, parallel-group RCT was conducted with a pilot sample of 50 participants randomized to a 6-week psycho-behavioural intervention or usual care. Feasibility was assessed through recruitment, completion, attendance, attrition, and retention rates; acceptability via satisfaction surveys and semi-structured interviews. Outcomes included CRF, physical activity, dietary behaviours, sleep disturbance, anxiety and depressive symptoms, assessed at baseline and within 1-week post-intervention. Feasibility benchmarks were met: recruitment 52.6%, completion 72.0%, attendance 74.7%, attrition 6.0%, and retention 94.0%. High satisfaction and positive qualitative feedback indicated good acceptability. Repeated Measures ANOVA revealed significant group-by-time interaction effects favouring the intervention for reducing CRF (F = 6.49, p = 0.014; Hedges' g = -0.71), enhancing physical activity (F = 19.76, p < 0.001; Hedges' g = 1.24), improving dietary behaviours (F = 4.74, p = 0.034; Hedges' g = 0.61), and alleviating sleep disturbance (F = 9.64, p = 0.003; Hedges' g = -0.86), but not for anxiety (F = 3.01, p = 0.089; Hedges' g = -0.48) or depressive symptoms (F = 3.77, p = 0.058; Hedges' g = -0.54). The psycho-behavioural intervention demonstrated feasibility, acceptability, and preliminary efficacy in reducing CRF, enhancing physical activity, improving dietary behaviours, and alleviating sleep disturbance in this population. A definitive RCT is warranted to evaluate longer-term effects.
Clinical relevance
Is a 6-week psycho-behavioural intervention feasible, acceptable, and preliminarily efficacious in reducing cancer-related fatigue (CRF) and improving related health outcomes in post-treatment colorectal cancer patients compared with usual care? __SNAPSHOT__ {"studyDesign":"Single-blinded, parallel-group pilot randomised controlled trial (RCT)","setting":"Not reported (institution type and country not specified in abstract)","sampleSize":"n=50, randomised to intervention (n not individually reported per arm) or usual care (n not individually reported per arm)","population":"Post-treatment colorectal cancer patients experiencing cancer-related fatigue; additional inclusion/exclusion criteria not reported in abstract","intervention":"6-week psycho-behavioural intervention (specific components, modality, and dose not described in abstract)","comparator":"Usual care","primaryOutcome":"Feasibility (recruitment, completion, attendance, attrition, and retention rates) and acceptability (satisfaction surveys and semi-structured interviews); preliminary efficacy outcomes included CRF, physical activity, dietary behaviours, sleep disturbance, anxiety, and depressive symptoms","followUp":"Assessed at baseline and within 1 week post-intervention (approximately 6–7 weeks total); no longer-term follow-up reported","fundingSource":"Not reported"}
Key findings
Feasibility benchmarks were met: recruitment rate 52.6%, completion rate 72.0%, session attendance rate 74.7%, attrition rate 6.0%, and retention rate 94.0%. Acceptability was supported by high satisfaction scores and positive qualitative feedback. Repeated Measures ANOVA revealed statistically significant group-by-time interaction effects favouring the intervention for the following outcomes: CRF (F=6.49, p=0.014; Hedges' g=−0.71, a medium-to-large effect); physical activity (F=19.76, p<0.001; Hedges' g=1.24, a large effect); dietary behaviours (F=4.74, p=0.034; Hedges' g=0.61, a medium effect); and sleep disturbance (F=9.64, p=0.003; Hedges' g=−0.86, a large effect). No statistically significant group-by-time interaction was observed for anxiety (F=3.01, p=0.089; Hedges' g=−0.48) or depressive symptoms (F=3.77, p=0.058; Hedges' g=−0.54), though effect sizes for both were in the small-to-medium range. Absolute between-group differences (means, standard deviations, and raw score changes) are not reported in the abstract. NNT cannot be calculated from available data. Adverse events were not reported.
Practice implications
This pilot RCT demonstrates that a 6-week psycho-behavioural intervention is feasible and acceptable in post-treatment colorectal cancer patients and is associated with statistically significant and moderately-to-substantially sized preliminary improvements in CRF, physical activity, dietary behaviours, and sleep disturbance over a very short follow-up window (≤1 week post-intervention). The study did NOT establish efficacy for anxiety or depressive symptoms at this sample size. Critically, this is a pilot trial powered for feasibility, not efficacy; the sample size of 50 is insufficient to draw confirmatory conclusions about treatment effects, and the results are explicitly preliminary. The very short follow-up (1 week post-intervention) means durability of effect is entirely unknown. The intervention content, delivery modality, and provider qualifications are not described in the abstract, limiting replicability assessment. Patients NOT adequately represented include those receiving active treatment, those with advanced-stage disease, and populations beyond the unstated recruitment setting. While the Hedges' g values for CRF (−0.71) and sleep (−0.86) are clinically meaningful in magnitude, the absence of absolute score changes and minimal clinically important difference (MCID) benchmarks prevents definitive judgment on clinical significance. NOTE: This summary is based on the published abstract only; the full text may contain additional methodological detail. __LIMITATIONS__ Pilot sample of only n=50 is underpowered for confirmatory efficacy conclusions; all efficacy findings are explicitly preliminary.,Extremely short post-intervention follow-up (within 1 week) precludes any assessment of durability or longer-term benefit.,Single-blinded design: participant blinding to intervention assignment is not feasible in behavioural RCTs; assessor blinding status and robustness of blinding are not described in the abstract.,Intervention components, modality (individual vs. group, in-person vs. remote), session length, and facilitator qualifications are not described in the abstract, limiting replicability.,Recruitment rate of 52.6% raises questions about selection bias and generalisability to patients who declined participation.,Completion rate of 72.0% and the nature of missing data handling (intent-to-treat vs. per-protocol) are not detailed in the abstract, which may introduce attrition bias.,Absence of reported absolute mean score changes and MCID thresholds prevents translation of statistically significant group-by-time interactions into clinically meaningful effect estimates.,No longer-term follow-up arm; whether benefits persist beyond the immediate post-intervention period is unknown.,The usual care comparator is not characterised; its content may vary by site and confound comparative estimates.,Funding source is not reported, precluding assessment of potential conflicts of interest.,Generalisability is limited by unstated geographic setting, cancer stage, treatment history, and comorbidity profile of enrolled participants. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This well-conducted pilot RCT demonstrates that a 6-week psycho-behavioural intervention is feasible and acceptable in post-treatment colorectal cancer patients, with preliminary signals of medium-to-large effect sizes favouring the intervention for CRF reduction, physical activity, dietary behaviours, and sleep disturbance. However, the sample of 50, the 1-week post-intervention endpoint, and the absence of detailed intervention description mean these findings are hypothesis-generating only and should not alter practice. A definitive, adequately powered RCT with longer follow-up and standardised usual care is required before this intervention can be recommended.