Evidence map›Paper›PMID 28408335›Full record

Trial reportContemporary clinical trials2017

Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.

Sarah A Kelleher, Caroline S Dorfman, Jen C Plumb Vilardaga, Catherine Majestic, Joseph Winger, Vicky Gandhi, Christine Nunez, Alyssa Van Denburg, Rebecca A Shelby, Shelby D Reed and 7 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 24% 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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Relationship between social support, physical symptoms, and depression in women with breast cancer and pain.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Breast cancer survivors with pain: an examination of the relationships between body mass index, physical activity, and symptom burden.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  11. Review
  12. Article
  13. Article
  14. Pain, depressive symptoms, and self-efficacy for pain management: examination in African-American women with breast cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Precision Medicine.Annual review of statistics and its application · 2019
    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

17 authors at 4 institutions in 1 country.

Sarah A KelleherDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Caroline S DorfmanDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Jen C Plumb VilardagaDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Catherine MajesticDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Joseph WingerDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Vicky GandhiDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Christine NunezDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Alyssa Van DenburgDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Rebecca A ShelbyDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States.
Shelby D ReedDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States.
Susan MurphyDepartment of Statistics, University of Michigan, Ann Arbor, MI, United States.
Marie DavidianDepartment of Statistics, North Carolina State University, Raleigh, NC, United States.
Eric B LaberDepartment of Statistics, North Carolina State University, Raleigh, NC, United States.
Gretchen G KimmickDepartment of Internal Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States.
Kelly W WestbrookDepartment of Internal Medicine, Duke Cancer Institute, Duke University Medical Center, Durham, NC, United States.
Amy P AbernethyDivision of Medical Oncology, Duke University Medical Center, Durham, NC, United States.
Tamara J SomersDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States. Electronic address: tamara.somers@duke.edu.
Duke Medical Center · USDuke University · USNorth Carolina State University · USUniversity of Michigan · US

Funding

Statistical Methods for Cancer Clinical TrialsP01CA142538 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KOSOROK, MICHAEL R · 2010 to 2019
$21.3M
Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMARTR01CA202779 · NCI · DUKE UNIVERSITY · PI SOMERS, TAMARA J · 2016 to 2020
$2.8M
NCI NIH HHS P01 CA142538NCI NIH HHS R01 CA202779
6 · The paper itself

Abstract

BACKGROUND/

aimsPain is common in cancer patients and results in lower quality of life, depression, poor physical functioning, financial difficulty, and decreased survival time. Behavioral pain interventions are effective and nonpharmacologic. Traditional randomized controlled trials (RCT) test interventions of fixed time and dose, which poorly represent successive treatment decisions in clinical practice. We utilize a novel approach to conduct a RCT, the sequential multiple assignment randomized trial (SMART) design, to provide comparative evidence of: 1) response to differing initial doses of a pain coping skills training (PCST) intervention and 2) intervention dose sequences adjusted based on patient response. We also examine: 3) participant characteristics moderating intervention responses and 4) cost-effectiveness and practicality. METHODS/

designBreast cancer patients (N=327) having pain (ratings≥5) are recruited and randomly assigned to: 1) PCST-Full or 2) PCST-Brief. PCST-Full consists of 5 PCST sessions. PCST-Brief consists of one 60-min PCST session. Five weeks post-randomization, participants re-rate their pain and are re-randomized, based on intervention response, to receive additional PCST sessions, maintenance calls, or no further intervention. Participants complete measures of pain intensity, interference and catastrophizing.

conclusionsNovel RCT designs may provide information that can be used to optimize behavioral pain interventions to be adaptive, better meet patients' needs, reduce barriers, and match with clinical practice. This is one of the first trials to use a novel design to evaluate symptom management in cancer patients and in chronic illness; if successful, it could serve as a model for future work with a wide range of chronic illnesses.

Indexed as

Adaptation, PsychologicalAdultBreast NeoplasmsCognitive Behavioral TherapyCost-Benefit AnalysisFemaleHumansPain ManagementPain MeasurementBreast cancerNovel trial designsPainPain coping skills trainingSmartSymptom management

Identifiers

PMID28408335
PMCPMC5681223
OpenAlexW2606726416

What OpenQuestion holds

Textmetadata
LicenceTDM
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.