Evidence map›Paper›PMID 33961667›Full record

Trial reportPloS one2021

Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors.

Franziska Holtdirk, Anja Mehnert, Mario Weiss, Johannes Mayer, Björn Meyer, Peter Bröde, Maren Claus, Carsten Watzl

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03643640 (Evaluation of a Web-based Psychological Intervention as add-on to Care as Usual in Breast Cancer Survivors), which is not on this map. Cited by 37 papers, 17 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 17 pooled it
4.1field-weighted citation impact, top 4% of its field
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.

NCT03643640 nacompletednot on this map

Evaluation of a Web-based Psychological Intervention as add-on to Care as Usual in Breast Cancer Survivors: Effect on Lifestyle and Psychometric Outcome

TypeinterventionalSponsorTechnical University of DortmundRan2018 to 2020Enrolled360ConditionsBreast CancerArmsOptimune, Care-As-Usual
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 17 syntheses or guidelines pooled it, 62 citations in OpenAlex.

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  15. Effectiveness of telemedicine-based psychosocial intervention for breast cancer patients: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
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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

8 authors at 3 institutions in 1 country.

Franziska HoltdirkResearch Department, Gaia Group, Hamburg, Germany.
Anja MehnertDepartment of Medical Psychology and Medical Sociology University Hospital of Leipzig, Leipzig, Germany.
Mario WeissResearch Department, Gaia Group, Hamburg, Germany.
Johannes MayerResearch Department, Gaia Group, Hamburg, Germany.
Björn MeyerResearch Department, Gaia Group, Hamburg, Germany.ORCID 0000-0003-1100-0260
Peter BrödeLeibniz Research Centre (IfADo), Technical University of Dortmund, Dortmund, Germany.ORCID 0000-0001-8107-704X
Maren ClausLeibniz Research Centre (IfADo), Technical University of Dortmund, Dortmund, Germany.ORCID 0000-0001-8732-0645
Carsten WatzlLeibniz Research Centre (IfADo), Technical University of Dortmund, Dortmund, Germany.ORCID 0000-0001-5195-0995
GAIA (Germany) · DETU Dortmund University · DEUniversity Hospital Leipzig · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAfter the acute treatment phase, breast cancer patients often experience low quality of life and impaired mental health, which could potentially be improved by offering cognitive behavioural therapy (CBT) and addressing exercise and dietary habits. However, CBT and other behavioural interventions are rarely available beyond the acute treatment phase. Internet-based interventions could bridge such treatment gaps, given their flexibility and scalability. In this randomized controlled trial (RCT), we investigated the effects of such an intervention ("Optimune") over three months.

methodsThis RCT included 363 female breast cancer survivors (age range = 30-70), recruited from the community, who had completed the active treatment phase. Inclusion criteria were: breast cancer diagnosis less than 5 years ago and acute treatment completion at least 1 month ago. Participants were randomly assigned to (1) an intervention group (n = 181), in which they received care as usual (CAU) plus 12-month access to Optimune immediately after randomization, or (2) a control group (n = 182), in which they received CAU and Optimune after a delay of 3 months. Primary endpoints were quality of life (QoL), physical activity, and dietary habits at three months. We hypothesized that intervention group participants would report better QoL, more physical activity, and improved dietary habits after 3 months.

resultsIntention-to-treat (ITT) analyses revealed significant effects on QoL (d = 0.27, 95% CI: 0.07-0.48) and dietary habits (d = 0.36, 95% CI: 0.15-0.56), but the effect on physical exercise was not significant (d = 0.30; 95% CI: 0.10-0.51). DISCUSSION: These findings suggest the effectiveness of Optimune, a new CBT-based Internet intervention for breast cancer survivors, in facilitating improvements in quality of life and dietary habits. Efforts to disseminate this intervention more broadly may be warranted.

trial registrationClinicalTrials.gov, NCT03643640. Registered August 23rd 2018, https://clinicaltrials.gov/ct2/show/NCT03643640.

Indexed as

Breast NeoplasmsInternet-Based InterventionMental HealthAdultAgedCancer SurvivorsDietFemaleHumansMiddle AgedQuality of Life

Identifiers

PMID33961667
PMCPMC8104369
OpenAlexW3159954902

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.