Evidence map›Paper›PMID 36152791›Full record

Trial reportContemporary clinical trials2022

Improving well-being for individuals with persistent pain after surgery for breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ: A randomized clinical trial.

Juliann M Stalls, Dana H Bovbjerg, Tamara J Somers, Jennifer C Plumb Vilardaga, Gretchen G Kimmick, Priscilla F McAuliffe, Francis J Keefe, Donna M Posluszny, Michael J L Sullivan, Alaattin Erkanli and 5 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04225585 (Improving Well-Being for Individuals With Persistent Pain After Surgery for Breast Cancer, Lobular Carcinoma in Situ, or Ductal Carcinoma in Situ), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 40% 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.

NCT04225585 nacompletednot on this map

Improving Well-Being for Individuals With Persistent Pain After Surgery for Breast Cancer, Lobular Carcinoma in Situ, or Ductal Carcinoma in Situ: A Randomized Clinical Trial That Compares Three Behavioral Intervention Strategies and Examines Psychological Factors as Drivers of the Continuing Burden of Persistent Pain

TypeinterventionalSponsorDuke UniversityRan2021 to 2026Enrolled316ConditionsCoping Skills Training for Persistent Post-Surgical Pain, General Health EducationArmsCST-PSP, General health education
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

15 authors at 3 institutions in 2 countries.

Juliann M StallsDepartment of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: juliann.stalls@duke.edu.
Dana H BovbjergUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, United States of America.
Tamara J SomersDepartment of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.
Jennifer C Plumb VilardagaDepartment of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.
Gretchen G KimmickDivision of Medical Oncology, Duke University Medical Center, Durham, NC, United States of America.
Priscilla F McAuliffeUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, United States of America.
Francis J KeefeDepartment of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.
Donna M PoslusznyUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, United States of America.
Michael J L SullivanDepartment of Psychology, McGill University, Montreal, Que., Canada.
Alaattin ErkanliDepartment of Biostatistics, Duke University, Durham, NC, United States of America.
Shelby D ReedDepartment of Medicine, Duke University School of Medicine, Durham, NC, United States of America.
Linda SuttonDuke Cancer Network, Duke University, Durham, NC, United States of America.
Lynda OwenDuke Cancer Network, Duke University, Durham, NC, United States of America.
Lisa MassaDepartment of Physical and Occupational Therapy, Duke University, Durham, NC, United States of America.
Rebecca A ShelbyDepartment of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, United States of America.
Duke University · USDuke Medical Center · USMcGill University · CA

Funding

Persistent Post-Mastectomy Pain: Randomized Clinical Trial of Targeted Pain Coping Skills Training (Targeted-PCST) with Mediational AnalysisR01CA249959 · NCI · DUKE UNIVERSITY · PI BOVBJERG, DANA H., SHELBY, REBECCA A · 2020 to 2024
$3.1M
NCI NIH HHS R01 CA249959
6 · The paper itself

Abstract

>276,000 Americans will be diagnosed with invasive breast cancer, lobular carcinoma in situ, or ductal carcinoma in situ this year and most will undergo breast surgery as part of their care. Although prognosis is excellent, many patients experience persistent post-surgical pain (PSP), which has no satisfactory pharmacological treatment. The causal contributions of pain-associated psychological factors (e.g., catastrophic thoughts about pain, psychological flexibility, self-efficacy) to the continuing burden of PSP have not yet been determined and may be opportune intervention targets. The randomized trial described here will compare the benefits of three manualized behavioral interventions for individuals with PSP. Participants will receive either: 1) self-guided health education (SGHE); 2) interventionist-guided health education (IGHE); or 3) interventionist-guided pain coping skills training with elements of acceptance and commitment therapy that specially target catastrophic thoughts about pain, self-efficacy, and psychological flexibility (CST-PSP). Participants will prospectively complete validated assessments of primary outcomes (PSP severity and interference) at baseline (pre-intervention) and 3-, 6-, and 12-months later. Validated measures of emotional distress and cancer-specific distress will be assessed as secondary outcomes. To test their roles as drivers of PSP, catastrophic thoughts about pain, self-efficacy, and psychological flexibility, will be assessed and statistically analyzed as mediators of hypothesized beneficial effects. The interventions' impacts on pain sensitivity and central sensitization will be investigated to test these physiological pathways as proximal drivers of PSP. To better characterize the patient experience, additional validated measures will be explored for associations with PSP, along with demographic and clinical factors. Trial registration: https://clinicaltrials.gov/ct2/show/NCT04225585, registered January 13, 2020.

Indexed as

Acceptance and Commitment TherapyBreast Carcinoma In SituBreast NeoplasmsCarcinoma, Intraductal, NoninfiltratingAdaptation, PsychologicalFemaleHumansPainAcceptance and commitment therapyBreast cancerBreast surgeryCentral sensitizationPain catastrophizingPain coping skills trainingPersistent painPost-surgical painPsychological flexibilitySelf-efficacy

Identifiers

PMID36152791
PMCPMC10001426
OpenAlexW4296545265

What OpenQuestion holds

Textmetadata
LicenceTDM
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.