Trial reportCancer medicine2025
The COMFORT Trial: A Randomised Control Trial Comparing Group-Based COMpassion-FOcused Therapy Techniques and Breathing Pattern ReTraining With Treatment as Usual on the Psychological Functioning of Patients Diagnosed With Cancer Recurrence.
Trial report in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
objectiveAlthough cancer-related distress has been well researched, few studies explicitly address distress triggered by a recurrent diagnosis. We developed a patient-informed, innovative, online intervention and performed a Randomised Control Trial (RCT) investigating the efficacy of combining Compassion-Focused Therapy (CFT) techniques and Breathing Pattern Retraining (BPR) on the reduction of distress in patients with recurrence compared with Treatment as Usual (TAU). Our hypothesis was COMFORT would be more effective at reducing overall indices of distress than treatment as usual in patients with recurrent cancer.
methodsOne hundred sixty patients with recurrent disease and a Distress Thermometer (DT) score >/= 4 were enrolled and randomised to receive either 6 weeks of COMFORT or TAU. Data were collected via self-report questionnaires at baseline (T1), post 6-week intervention (T2) and at 12 weeks (T3). The primary outcome was change in DT score at 18 weeks. A linear mixed effects model was used to compare change from baseline between groups, accounting for repeated measures within individuals. A random intercepts model was used, with categorical time, group and time × arm interaction as fixed effects.
resultsOne hundred sixty patients enrolled and 123 completed the protocol at 18 weeks. Participants mean age was 57 (SD-14). Over 50% had breast or gynecological cancer. Patient demographics were well matched between groups. Linear mixed-effects model and intent-to-treat analyses demonstrated a mean difference in the improvement in distress from baseline to 18 weeks of 1.09 units (95% CI: 0.24, 1.95) (p = 0.013) on the DT in the intervention group, consistent with the pre-specified minimum clinically significant difference. Secondary endpoints demonstrated a significant reduction in patient-reported distress in response to cancer as a traumatic event, and not significant but clinically important improvements in anxiety, depression and adjustment to cancer.
conclusionsCOMFORT demonstrates that an online intervention met its primary outcome of distress reduction. Further multisite trials are required.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.