Evidence map›Paper›PMID 36747246›Full record

Trial reportTrials2023

The COMFORT trial: a randomised control trial comparing group-based COMpassion-FOcussed therapy and breathing pattern ReTraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID.

Sinead Lynch, Damien Lowry, Clodagh Finnerty, Yvonne O'Meara, Donal Brennan

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05518591 (A Randomised Control Trial Comparing Compassion Focused Therapy and Breathing Pattern Retraining With Treatment as Usual in Patients Diagnosed With Cancer Recurrence During COVID.), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT05518591 naunknown statusnot on this map

A Randomised Control Trial Comparing Compassion Focused Therapy and Breathing Pattern Retraining With Treatment as Usual in Patients Diagnosed With Cancer Recurrence During COVID.

TypeinterventionalSponsorUniversity College DublinRan2022 to 2023Enrolled160ConditionsPsychological Distress, Cancer RecurrenceArmsCompassion Focused Therapy (CFT) combined with Breathing Pattern Retraining (BPR)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Sinead Lynch *Department of Psychology, Mater Misericordiae University Hospital, Dublin, Ireland. SineadLynch@mater.ie.
Damien Lowry *Department of Psychology, Mater Misericordiae University Hospital, Dublin, Ireland. dlowry@mater.ie.ORCID http://orcid.org/0000-0003-3533-2358
Clodagh FinnertyCOMFORT Trial, University College Dublin, Dublin, Ireland.
Yvonne O'MearaWomen's Cancer Survivorship Research Coordinator, School of Medicine, University College Dublin, Dublin, Ireland.
Donal BrennanMater Misericordiae University Hospital, Dublin, Ireland.

Funding

Irish Cancer Society COV21LYN
6 · The paper itself

Abstract

backgroundA cancer diagnosis is a known precipitant of psychological distress, with fear of recurrence being a well-documented distressing consequence of cancer. Cancer recurrence often results in an additional psychological burden, which may exacerbate as a result of the COVID-19 pandemic.

methodsThis is a single-centre, prospective, randomised controlled trial. Patients identified as having experienced cancer recurrence since March 2020 (the onset of the COVID-19 pandemic in Ireland) will be screened for participation. Eligible, consenting candidates who score 4 or higher on the Distress Thermometer will be enrolled in the study. Participants will be randomly allocated to receive either a 6-week, group-based, online, compassion-focussed therapy and breathing pattern retraining intervention or the control arm. Those in the control arm will all be offered the group intervention after the 18-week study period. The primary outcome is the Distress Thermometer score at 18 weeks post-baseline though secondary outcomes will include measures of mood, traumatic distress and mental adjustment to cancer. DISCUSSION: To our knowledge, this protocol describes the first RCT which directly examines the effect of a group-based psychological intervention on Irish patients experiencing cancer recurrence in the context of COVID-19. The outcome of this trial is likely to be twofold: It will determine if the psychological intervention achieves its primary objective of distress amelioration 3 months post-intervention and to establish the feasibility of delivering this intervention in a virtual format.

trial registrationClinicalTrials.gov NCT05518591. Registered on 25 August 2022. All items from the World Health Organization Trial Registration Data set have been included.

Indexed as

COVID-19NeoplasmsEmpathyHumansPandemicsProspective StudiesRespirationTreatment OutcomeCancerCompassion-focussed therapyOncologyPsychological distressRadical breathing retrainingRandomised control trialRecurrence

Identifiers

PMID36747246
PMCPMC9901386

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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 OpenQuestion graph.