Evidence map›Paper›PMID 34738912›Full record

Trial reportJournal of medical Internet research2021

A Digital Self-management Program (Help to Overcome Problems Effectively) for People Living With Cancer: Feasibility Randomized Controlled Trial.

Hayley Wright, Faith Martin, Wendy Clyne, Cain C T Clark, Gabriela Matouskova, Michael McGillion, Andrew Turner

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of medical Internet research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Interactive digital tools to support empowerment of people with cancer: a systematic literature review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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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

7 authors.

Hayley Wright *Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Coventry, United Kingdom.ORCID 0000-0003-2199-8255
Faith Martin *Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Coventry, United Kingdom.ORCID 0000-0002-0141-1210
Wendy Clyne *National Institute for Health Research, Research Design Service South West, Peninsula Medical School, University of Plymouth, Devon, United Kingdom.ORCID 0000-0003-1523-7003
Cain C T Clark *Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Coventry, United Kingdom.ORCID 0000-0002-6610-4617
Gabriela Matouskova *Hope For The Community, Community Interest Company, The Enterprise Hub, Coventry, United Kingdom.ORCID 0000-0002-5743-5342
Michael McGillion *School of Nursing, McMaster University, Hamilton, ON, Canada.ORCID 0000-0002-1343-7012
Andrew Turner *Centre for Intelligent Healthcare, Research Institute for Health and Wellbeing, Coventry University, Coventry, United Kingdom.ORCID 0000-0001-6538-4242

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe present the results of a feasibility, randomized waitlist control group (CG) parallel design study with a 1:1 allocation ratio. Participants were randomized into an intervention group (IG) or a waitlist CG. The intervention was a 6-week digital self-management program, Help to Overcome Problems Effectively (HOPE), for people with cancer.

objectiveThis study aims to test the feasibility of a digitally delivered self-management program for people with cancer. This will inform the design of a definitive randomized controlled trial. In addition, a preliminary assessment of the impact of the HOPE program via secondary outcomes will be used to assess signals of efficacy in a trial context.

methodsParticipants were drawn from an opportunity sample, referred by Macmillan Cancer Support, and were invited via email to participate in the study (N=61). Primary outcomes were rates of recruitment, retention, follow-up, completion and adherence, sample size and effect size estimation, and assessment of progression criteria for a definitive trial. Secondary outcomes were self-report measures of participants' positive mental well-being, depression, anxiety, and patient activation (ie, confidence in managing their cancer). The intervention and data collection took place on the web.

resultsThe recruitment rate was 77% (47/61). A total of 41 participants completed the baseline questionnaires and were randomized to either the IG (n=21) or the waitlist CG (n=20). The retention rate (attending all program sessions) was greater than 50% (all: 21/41, 51%, IG: 10/21, 48%; and CG: 11/20, 55%). The follow-up rate (completing all questionnaires) was greater than 80% (all: 33/41, 80%; IG: 16/21, 76%; and CG: 17/20, 85%). The completion rate (attending ≥3 sessions and completing all questionnaires) was greater than 60% (all: 25/41, 61%; IG: 13/21, 62%; and CG: 12/20, 60%). Engagement data showed that participants viewed between half (5.1/10, 51%) and three-quarters (12.2/16, 76%) of the pages in each session.

conclusionsAll progression criteria for a definitive trial were met, as supported by the primary outcome data. The IG showed improved postprogram scores on measures of positive mental well-being, depression, anxiety, and patient activation. A full-scale trial of the digital HOPE program for people with cancer will allow us to fully evaluate the efficacy of the intervention relative to a CG.

trial registrationISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/24264.

Indexed as

NeoplasmsSelf-ManagementAnxietyAnxiety DisordersFeasibility StudiesHumanscancerdigitalpositive psychologyself-managementsurvivorship

Identifiers

PMID34738912
PMCPMC8726569

What OpenQuestion holds

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Registered trials

None linked

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.