Pain Coping Skills for Colorectal Cancer Survivors

NCT ID: NCT02706301

Last Updated: 2019-01-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-10-31

Brief Summary

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Colorectal cancer survivors experience long-term negative physical and psychosocial consequences of their disease. There is a critical need to develop novel behavioral interventions for improving colorectal cancer survivor outcomes. The investigators have developed a pain management intervention for colorectal cancer survivors that focuses on addressing both pain and psychological distress. Colorectal cancer survivors who endorse pain and comorbid psychological distress as a concern during a clinic-based survivorship care consult will be recruited. Participants will be randomized into either: Telephone-Based Coping Skills Training (CST) for pain and comorbid psychological distress or standard care. The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain and psychological distress. The standard care control condition will receive resources and referrals related to managing survivorship health.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telephone-Based Coping Skills Training (CST)

The CST condition will receive 5 sessions of a cognitive behavior theory-based protocol that teaches coping skills (e.g., relaxation, activity pacing/planning, cognitive restructuring) relevant to managing pain as well as psychological distress.

Group Type EXPERIMENTAL

Telephone-Based Coping Skills Training (CST)

Intervention Type BEHAVIORAL

Standard care control

The standard care control condition will receive resources and referrals related to survivorship health. This information will be provided to the participant during their initial survivorship care consult.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telephone-Based Coping Skills Training (CST)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \>21 years old
* personal history of colorectal cancer
* finished active cancer treatment within the past 12 months
* reported pain as a concern as well as psychological distress on a National Comprehensive Cancer Network screener
* able to speak and read English
* able and willing to give informed consent

Exclusion Criteria

* currently undergoing active cancer treatment
* have a major mental illness (e.g., schizophrenia)
* have a mental illness that is not being treated/controlled (e.g., bipolar disorder)
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah A. Kelleher, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Cancer Institute

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00063330

Identifier Type: -

Identifier Source: org_study_id

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