NCT02783755 Clinical Trial - National Cancer Institute || mPCST in Reducing Pain and Disability in Patients with Breast Cancer from Medically Underserved Communities

NCT02783755 Clinical Trial - National Cancer Institute

mPCST in Reducing Pain and Disability in Patients with Breast Cancer from Medically Underserved Communities

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ON THIS PAGE

• Basic Trial Information
• Trial Description
  • Summary
  • Further Study Information
  • Eligibility Criteria
• Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Trial IDs
No phase specified	Supportive care	Active	21 and over	Pro00065621 NCI-2015-02184, NCT02783755

Trial Description

Summary

This pilot clinical trial studies how well mobile health (mHealth) pain coping skills training (mPCST) works in reducing pain and disability in patients with breast cancer from medically underserved communities. Studying mPCST may help develop a personalized training program to reduce pain and disability in patients with breast cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. To develop the full low-literacy mPCST protocol (i.e., therapist manual, patient manual including handouts, and the smartphone materials) and a beta version of the basic smart phone components of the protocol for cancer patients with pain.

II. To conduct focus groups with women who have breast cancer and pain in medically underserved areas to refine the developed mPCST protocol and basic smart phone components based on qualitative and quantitative information received from focus group participants.

III. To pilot test the fully developed mPCST protocol including assessments, intervention, and smart phone components in women with breast cancer and pain in medically underserved areas (N=20).

OUTLINE:

PART I: The low-literacy mPCST protocol specifically for women with breast cancer who have pain and live in medically underserved areas is developed, as well as a beta version of the basic smart phone components of the mPCST.

PART II (focus group): Patients participate in one focus group for 60-90 minutes. Patients also receive assessments over approximately 20 minutes that examine health literacy, pain severity, pain interference, and mPCST acceptability.

PART III (pilot testing mPCST): Patients complete 5 video-conferencing mPCST intervention sessions over 50 minutes over 8 weeks. Patients also record daily pain levels and skills practice experience.

Eligibility Criteria

Inclusion Criteria:

Primary diagnosis of breast cancer within the last three years

Having a life expectancy of at least 12 months

Having 1 clinical pain rating of >= 3 gathered as part of routine clinic visits or reports pain of > 3 at least three days in the last two week upon accural

Exclusion Criteria:

Cognitive impairment (part II only)

Metastases to the brain

Presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff

Current or past (< 6 months) engagement in PCST for cancer

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Duke University Medical Center

• National Cancer Institute

Tamara Somers, Principal Investigator

Trial Sites

U.S.A.

North Carolina

Durham

Duke University Medical Center

Tamara Somers
Ph: 919-416-3408
Email: tamara.somers@duke.edu

Tamara Somers
Principal Investigator

Henderson

Maria Parham Hospital

Nancy Garrett-Mead
Email: nancy.garrett-mead@duke.edu

Nancy Garrett-Mead
Principal Investigator

Laurinburg

Scotland Memorial Hospital-Laurinburg Cancer Center

Nancy Garrett-Mead
Email: nancy.garrett-mead@duke.edu

Nancy Garrett-Mead
Principal Investigator

Lumberton

Southeastern Regional Medical Center

Nancy Garrett-Mead
Email: nancy.garrett-mead@duke.edu

Nancy Garrett-Mead
Principal Investigator

Smithfield

Johnston Memorial Hospital

Nancy Garrett-Mead
Email: nancy.garrett-mead@duke.edu

Nancy Garrett-Mead
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT02783755

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.