Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03207360
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2017-06-30
Brief Title:
Pain Coping Skills and Meaning-Centered Intervention
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Pain Coping Skills Training and Meaning-Centered Intervention for Cancer Pain
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study seeks to develop and test a novel psychosocial pain management intervention for patients with advanced cancer It is hypothesized that the intervention will demonstrate feasibility acceptability and preliminary efficacy The first aim is to develop a combined pain coping skills training and meaning-centered psychotherapy intervention The second aim is to test the interventions feasibility and acceptability as well as preliminary efficacy for improving primary outcomes ie pain pain interference and meaning in life and secondary outcomes Two efficacious theory-driven interventions will be integrated to address pain management by teaching pain coping skills with a novel emphasis on enhancing a sense of meaning in life Participants will be patients with advanced cancer and moderate-to-severe pain The study will be conducted in two phases Phase I of the study will be intervention development The intervention content will be guided by theory and mentoring from a team of leading experts in pain management and meaning-centered psychotherapy Initial intervention content will be further informed by interviews with patients with advanced cancer Content will then be refined through an iterative patient testing process Phase II of the study will be a single-arm pilot trial testing the intervention The intervention will be delivered in-person and consist of four 45-to-60 minute therapy sessions delivered using videoconferencing technology Study measures will be collected at baseline 0 weeks immediately post-intervention 5 weeks and 4-weeks post-intervention 9 weeks
Detailed Description:
Effective pain management is a major healthcare concern for patients with advanced cancer Compared to patients with early-stage disease those with advanced cancer report higher levels of pain and greater functional impairment related to pain There is a critical need for psychosocial pain management interventions that are specifically designed to address the suffering of patients with advanced cancer The proposed study seeks to develop and assess the feasibility acceptability and preliminary efficacy of a novel integration of pain coping skills training and meaning-centered psychotherapy for patients with advanced cancer and moderate-to-severe pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 130526-PF-17-054-01-PCSM | OTHER_GRANT | American Cancer Society | None |