Evidence map›Paper›PMID 32060166›Full record

ArticleBMJ open2020

Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors.

Courtney J Stevens, Mark T Hegel, Marie Anne Bakitas, Martha Bruce, Andres Azuero, Maria Pisu, Mary Chamberlin, Kimberly Keene, Gabrielle Rocque, Daphne Ellis and 12 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03915548 (A Phase III, Randomized, Single Blind, Attention Controlled, Multi-center Study of the Effects of a Rehabilitation Intervention on Participation Restrictions of Female Breast Cancer Survivors), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 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.

NCT03915548 nacompletednot on this map

A Phase III, Randomized, Single Blind, Attention Controlled, Multi-center Study of the Effects of a Rehabilitation Intervention on Participation Restrictions of Female Breast Cancer Survivors

TypeinterventionalSponsorMGH Institute of Health ProfessionsRan2019 to 2024Enrolled303ConditionsBreast Cancer FemaleArmsThe Behavioral Activation/ Problem Solving Intervention, Attention Control Condition
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
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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

22 authors.

Courtney J StevensPsychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.ORCID 0000-0002-5696-4904
Mark T HegelGeisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.
Marie Anne BakitasSchool of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Martha BrucePsychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Andres AzueroSchool of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Maria PisuDivision of Preventive Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Mary ChamberlinGeisel School of Medicine, Dartmouth College, Hanover, New Hampshire, USA.
Kimberly KeeneRadiation Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Gabrielle RocqueMedicine, Divisions of Hematology and Oncology, and Geriatrics, Gerontology, and Palliative Care, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Daphne EllisPsychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Tiffany GilbertPsychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Jamme L MorencyPhysical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Robin M NewmanOccupational Therapy, Boston University College of Health and Rehabilitation Sciences Sargent College, Boston, Massachusetts, USA.
Megan E CodiniPhysical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Karen E ThorpPhysical Medicine and Rehabilitation, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Sarah M Dos AnjosOccupational Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Danielle Z CloydSchool of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Jennifer EcholsSchool of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Ashley N MilfordSchool of Nursing, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Stacey A IngramDepartment of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Jasmine DavisDepartment of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Kathleen Doyle LyonsPsychiatry Research, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA kathleen.d.lyons@dartmouth.edu.ORCID 0000-0002-8895-4612

Funding

Translational Engineering in Cancer (TEC)P30CA023108 · NCI · DARTMOUTH COLLEGE · PI Steven D Leach · 1985 to 2026
$91.3M
SYNERGY: The Dartmouth Center for clinical and Translational ScienceUL1TR001086 · NCATS · DARTMOUTH COLLEGE · PI GREEN, ALAN I · 2013 to 2017
$18.3M
Training Geriatric Mental Health Services ResearchersT32MH073553 · NIMH · DARTMOUTH-HITCHCOCK CLINIC · PI BRUCE, MARTHA L · 2005 to 2019
$6.4M
Optimizing functional recovery of breast cancer survivorsR01CA225792 · NCI · MGH INSTITUTE OF HEALTH PROFESSIONS · PI LYONS, KATHLEEN DOYLE · 2019 to 2023
$3.0M
NCATS NIH HHS UL1 TR001086NCI NIH HHS P30 CA023108NCI NIH HHS R01 CA225792NIMH NIH HHS T32 MH073553
6 · The paper itself

Abstract

introductionMany breast cancer survivors report an inability to fully participate in activities of daily living after completing cancer treatment. Reduced activity participation is linked to negative consequences for individuals (eg, depression, reduced quality of life) and society (reduced workforce participation). There is currently a lack of evidence-based interventions that directly foster cancer survivors' optimal participation in life roles and activities. Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors. METHODS AND ANALYSIS: This protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors' activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1-3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later. ETHICS AND DISSEMINATION: Study procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03915548; Pre-results.

Indexed as

Activities of Daily LivingBreast NeoplasmsCancer SurvivorsFemaleHumansQuality of LifeRandomized Controlled Trials as Topicadult oncologybreast tumoursrehabilitation medicine

Identifiers

PMID32060166
PMCPMC7044873

What OpenQuestion holds

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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.