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Clinical Trials/NCT05115825
NCT05115825
Completed
Not Applicable

Survivors of Head and Neck Cancer: Optimizing Pain Management

OHSU Knight Cancer Institute2 sites in 1 country33 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Carcinoma
Sponsor
OHSU Knight Cancer Institute
Enrollment
33
Locations
2
Primary Endpoint
Depression
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

This clinical trial improves an existing pain management program and tests its effect on head and neck cancer survivors. This trial aims to find a better program to improve pain-related physical functioning, mood, and quality of life in a sample of individuals who have undergone treatment for head and neck cancer.

Detailed Description

PRIMARY OBJECTIVES: I. Adapt an existing telehealth pain management intervention to target improvement of pain-related physical functioning, mood, substance use, and quality of life in a local sample of veteran head and neck cancer (HNC) survivors. II. Conduct a pilot of the adapted intervention to examine the feasibility (accrual, adherence, attrition) and acceptability (participant satisfaction) that will form the basis of a well-powered, randomized clinical trial submitted for funding to the National Institutes of Health (NIH), American Cancer Society (ACS), or Veterans Affairs (VA). OUTLINE: Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks. After completion of study, patients are followed up at 2 months.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
May 16, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shannon Madore, Ph.D.

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • Clinically confirmed diagnosis of HNC for which the participants have completed curative cancer treatment at the VA hospital or Oregon Health \& Science University (OHSU) within the 3-12 months following treatment
  • Self-reported current pain of 4 or higher, using the 0-10 Numeric Pain Rating (NRS) (0="no pain" to 10="the worst pain imaginable")
  • Self-report of pain 4 or higher on two occasions, more than three weeks apart, since the completion of curative treatment

Exclusion Criteria

  • Enrolled in hospice
  • Have substantial hearing or visual difficulties that would impair ability to participate
  • Have inadequate cognitive functioning as indicated by medical record review and/or interactions with clinical staff. If needed the investigators can follow up with the St. Louis University Mental State Examination (score of \< 22/30) (SLUMS); or
  • Have untreated severe psychiatric illness that would impact the ability to consent and participate in the intervention
  • Had only surgical treatment for their HNC

Outcomes

Primary Outcomes

Depression

Time Frame: Up to 2 months

Will be assessed by the Patient Health Questionnaire. Scores of 5, 10, 15, and 20 represent point scale for mild, moderate, moderately severe and severe depression, respectively.

Pain-interference

Time Frame: Up to 2 months

Will be assessed by Brief Pain Inventory. Will be assessed as 1-4=mild pain; 5-6 moderate pain; 7-10 severe pain.

Pain coping self-efficacy

Time Frame: Up to 2 months

Will be assessed by the Chronic Pain Self-Efficacy Scale.

Secondary Outcomes

  • Head and neck cancer related quality of life(Up to 2 months)
  • Substance use(Up to 2 months)

Study Sites (2)

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