Evidence map›Paper›PMID 27887581›Full record

Trial reportBMC cancer2016

Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors.

Vera Atema, Marieke van Leeuwen, Hester S A Oldenburg, Valesca Retèl, Marc van Beurden, Myra S Hunter, Neil K Aaronson

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02672189 (A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Breast Cancer Patients With Climacteric Symptoms), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.0field-weighted citation impact, top 13% 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.

NCT02672189 phase3completednot on this map

A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Breast Cancer Patients With Climacteric Symptoms

TypeinterventionalSponsorThe Netherlands Cancer InstituteRan2015 to 2019Enrolled254ConditionsClimacteric Symptoms, Breast Cancer SurvivorsArmsEVA-Online
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Supportive care in cancer-a MASCC perspective.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Review
  6. Article
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 at 3 institutions in 2 countries.

Vera AtemaDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Marieke van LeeuwenDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Hester S A OldenburgDepartment of Surgical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Valesca RetèlDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Marc van BeurdenDepartment of Gynecology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Myra S HunterDepartment of Psychology (at Guy's), Institute of Psychiatry, Kings College London, 5th floor Bermondsey Wing, Guy's Campus, SE1 9RT, London, UK.
Neil K AaronsonDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. n.aaronson@nki.nl.
The Netherlands Cancer Institute · NLOncode Institute · NLKing's College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMenopausal symptoms are common and may be particularly severe in younger women who undergo treatment-induced menopause. Medications to reduce menopausal symptoms are either contra-indicated or have bothersome side effects. Previous studies have demonstrated that face-to-face cognitive behavioral therapy (CBT) is effective in alleviating menopausal symptoms in women with breast cancer. However, compliance with face-to-face CBT programs can be problematic. A promising approach is to use the Internet to make this form of CBT more accessible and feasible for patients. This study is evaluating the efficacy and cost-effectiveness of an Internet-based CBT program, with or without therapist guidance, in alleviating or reducing the severity of menopausal symptoms. METHODS/

designIn a multicenter, randomized controlled trial we are evaluating the efficacy of two Internet-based CBT programs in alleviating or reducing the impact of menopausal symptoms, and particularly hot flushes and night sweats, in breast cancer survivors who have experienced a treatment-induced menopause. Secondary outcomes include sexual functioning, sleep quality, hot flush frequency, psychological distress, health-related quality of life and cost-effectiveness. We will recruit 248 women who will be randomized to either a therapist guided or a self-management version of the 6-week Internet-based CBT program, or to a usual care, waiting list control group. Self-administered questionnaires are completed at baseline (T0), and at 10 weeks (T1) and 24 weeks (T2) post-randomization. DISCUSSION: Internet-based CBT is a potentially useful treatment for reducing menopausal symptoms in breast cancer survivors. This study will provide evidence on the efficacy and cost-effectiveness of such an Internet-based CBT program, with or without therapist support. If demonstrated to be efficacious and cost-effective, the availability of such structured supportive intervention programs will be a welcome addition to standard medical treatment offered to cancer patients with treatment-induced menopause.

trial registrationThe study is retrospectively registered at ClinicalTrials.gov on January 26th 2016 ( NCT02672189 ).

Indexed as

AdultBreast NeoplasmsCognitive Behavioral TherapyCost-Benefit AnalysisFemaleHealth SurveysHot FlashesHumansInternetMenopauseMiddle AgedQuality of LifeResearch DesignRetrospective StudiesSelf CareSexual BehaviorBreast cancerCognitive behavioral therapyCost-effectivenesseHealthHot flushesInternet-basedMenopauseRandomized controlled trialSelf-management

Identifiers

PMID27887581
PMCPMC5124313
OpenAlexW2555008461

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.