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Behavioral Pain Intervention for Older Cancer Patients

NCT ID: NCT07300995

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2027-06-01

Brief Summary

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This randomized controlled trial examines a 1-session, telehealth pain coping skills training (PCST) protocol with five 15-minute maintenance calls (Brief PCST-Community) adapted for women with breast cancer in medically underserved areas. Pain, health-related quality of life, and self-efficacy for pain management will be assessed at baseline and 10 and 15 weeks later.

Detailed Description

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Pain continues to be persistent, interfering, and distressing for women with breast cancer. Behavioral cancer pain interventions continue to be poorly implemented with pronounced disparities for older breast cancer patients receiving oncology care in medically underserved areas. Within this context, this randomized controlled trial examines a 1-session, telehealth pain coping skills training (PCST) protocol with five 15-minute maintenance calls (Brief PCST-Community) adapted for women with breast cancer in medically underserved areas. Pain, health-related quality of life, and self-efficacy for pain management will be assessed at baseline and 10 and 15 weeks later.

Conditions

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Breast Cancer

Keywords

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cancer pain coping symptom management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pain Coping Skills Training

Participants in this group will complete a 50-minute telehealth session with a trained study nurse. During this session, they will be taught how to use several coping strategies for managing pain. This will be followed by 5 weekly, 15-minute supportive phone calls, where the study nurse will reinforce the learned coping skills. They will be asked to complete 2 follow-up surveys (10 weeks and 15 weeks after the first survey).

Group Type EXPERIMENTAL

Pain Coping Skills Training (PCST)

Intervention Type BEHAVIORAL

Behavioral pain intervention delivered via telehealth.

Usual Care

Participants in this group will not complete the new program. They will be asked to complete 2 follow-up surveys (10 and 15 weeks after the first survey).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pain Coping Skills Training (PCST)

Behavioral pain intervention delivered via telehealth.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Receiving cancer care at a Duke Cancer Network (DCN) clinic
* Stage I-IV breast cancer
* Self-reported pain on at least 10 days in the last month and pain rating of worst pain of 4 or greater on a 0-10 scale in the last week
* Biologically female
* Greater than or equal to 55 years old
* Ability to speak and read English
* Hearing and vision that allows for successful completion of videoconferencing and phone session

Exclusion Criteria

* Participation in the last 6 months in a pain coping skills training program
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Tamara Somers, PhD

Role: CONTACT

Phone: 919-416-3408

Email: [email protected]

Other Identifiers

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P30AG022845

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00117948

Identifier Type: -

Identifier Source: org_study_id