Targeted Pain Coping Skills Training (PCST) for Prevention and Treatment of Persistent Post-Mastectomy Pain
1 other identifier
interventional
28
1 country
1
Brief Summary
This study looks at whether a coping skills training program can help women manage pain and stress after breast surgery, and lower the risk of developing chronic pain. This coping skills program includes eight training sessions that are done by telephone. These sessions will focus on strategies for dealing with pain and stress, and how to apply these strategies to subjects' own experiences.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Oct 2015
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2015
CompletedFirst Posted
Study publicly available on registry
May 8, 2015
CompletedStudy Start
First participant enrolled
October 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2020
CompletedMay 1, 2020
November 1, 2019
4.2 years
March 6, 2015
April 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pain Burden
The investigators will use BCPQ (Brest Cancer Pain Questionnaire) questionnaire to record breast pain
0 month, mid intervention(at 6 weeks), post intervention( 3 months) and 6 months
Study Arms (2)
Psychosocial Intervention
ACTIVE COMPARATORTelephone-based psychosocial intervention involving Eight telephone encounters. Each encounter will focus on strategies for dealing with pain and stress, and how to apply these strategies to patients own experiences.
Treatment as usual
NO INTERVENTIONTreatment as usual
Interventions
Telephone-based psychosocial intervention involving Eight telephone encounters. Each encounter will focus on strategies for dealing with pain and stress, and how to apply these strategies to patients own experiences.
Eligibility Criteria
You may qualify if:
- prior diagnosis of Stage 0 to Stage III breast cancer
- received first breast surgery of total or partial mastectomy within the previous 9 months
- report average pain \>/= 3 during the first 9 months after surgery on the Breast Cancer Pain Questionnaire
- with sufficient ability to communicate in English in order to provide informed consent and complete study procedures and materials.
You may not qualify if:
- \< 21 years of age
- history of prior breast cancer surgery
- cognitive impairment documented in the medical record
- unable to provide meaningful consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca A Shelby, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2015
First Posted
May 8, 2015
Study Start
October 8, 2015
Primary Completion
January 6, 2020
Study Completion
January 6, 2020
Last Updated
May 1, 2020
Record last verified: 2019-11