Evidence map›Paper›PMID 26500019›Full record

Trial reportBMC cancer2015

A randomized controlled trial of web-based cognitive behavioral therapy for severely fatigued breast cancer survivors (CHANGE-study): study protocol.

H J G Abrahams, M F M Gielissen, M M Goedendorp, T Berends, M E W J Peters, H Poort, C A H H V M Verhagen, H Knoop

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 8% 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.

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

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

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  18. Cancer-related fatigue and its determinants in a cohort of women with breast cancer: the DAMA Cohort.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
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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 2 institutions in 1 country.

H J G AbrahamsExpert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, PO Box 9101, 916, 6500 HB, Nijmegen, The Netherlands. Harriet.Abrahams@radboudumc.nl.
M F M GielissenExpert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, PO Box 9101, 916, 6500 HB, Nijmegen, The Netherlands. marieke.gielissen@radboudumc.nl.
M M GoedendorpDepartment of Health Sciences, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. m.m.goedendorp@umcg.nl.
T BerendsExpert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, PO Box 9101, 916, 6500 HB, Nijmegen, The Netherlands. thea.berends@radboudumc.nl.
M E W J PetersDepartment of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. marlies.peters@radboudumc.nl.
H PoortExpert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, PO Box 9101, 916, 6500 HB, Nijmegen, The Netherlands. hanneke.poort@radboudumc.nl.
C A H H V M VerhagenDepartment of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands. stans.verhagen@radboudumc.nl.
H KnoopExpert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, PO Box 9101, 916, 6500 HB, Nijmegen, The Netherlands. hans.knoop@radboudumc.nl.
Radboud University Nijmegen · NLRadboud University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAbout one third of breast cancer survivors suffer from persistent severe fatigue after completion of curative cancer treatment. Face-to-face cognitive behavioral therapy (F2F CBT), especially designed for fatigue in cancer survivors, was found effective in reducing fatigue. However, this intervention is intensive and treatment capacity is limited. To extend treatment options, a web-based version of CBT requiring less therapist time was developed. This intervention is aimed at changing fatigue-perpetuating cognitions and behaviors. The efficacy of web-based CBT will be examined in a multicenter randomized controlled trial.

methodsIn total, 132 severely fatigued breast cancer survivors will be recruited and randomized to either an intervention condition or care as usual (ratio 1:1). Participants will be assessed at baseline and 6 months thereafter. The intervention group will receive web-based CBT, consisting of three F2F sessions and maximally eight web-based modules over a period of 6 months. The care as usual group will be on a waiting list for regular F2F CBT. The total duration of the waiting list is 6 months. The primary outcome of the study is fatigue severity. Secondary outcomes are functional impairments, psychological distress and quality of life. DISCUSSION: If web-based CBT is effective, it will provide an additional treatment option for fatigue in breast cancer survivors. Web-based CBT is expected to be less time-consuming for therapists than regular F2F CBT, which would result in an increased treatment capacity. Moreover, the intervention would become more easily accessible for a larger number of patients, and patients can save travel time and costs.

trial registrationDutch Trial Registry--NTR4309.

Indexed as

InternetAdultAgedBreast NeoplasmsCognitive Behavioral TherapyFatigueFemaleHumansMiddle AgedQuality of LifeSeverity of Illness IndexSurvivors

Identifiers

PMID26500019
PMCPMC4619089
OpenAlexW1900136306

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.