Pain Management for Head and Neck Cancer Survivors

Not Applicable

Active, not recruiting

• Conditions: Head and Neck Carcinoma
• Interventions: Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT05115825
• Lead Sponsor: OHSU Knight Cancer Institute

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.

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-10-29
• Study First Posted: 2021-11-10
• Primary Completion: 2024-10-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Study Completion: 2025-05-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (Mobile Pain Coping Skills Training)	Questionnaire Administration	Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks.
Supportive care (Mobile Pain Coping Skills Training)	Quality-of-Life Assessment	Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks.
Supportive care (Mobile Pain Coping Skills Training)	Behavioral Intervention	Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks.

Primary Outcome Measures

Name	Time	Method
Depression	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	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	Up to 2 months	Will be assessed by the Chronic Pain Self-Efficacy Scale.

Secondary Outcome Measures

Name	Time	Method
Head and neck cancer related quality of life	Up to 2 months	Will be assessed by the University of Michigan Quality of Life Questionnaire.
Substance use	Up to 2 months	Will be assessed by the PENN Cravings Questionnaire. Total score \>20 were considered to meet the threshold of craving, 15-20 were considered subthreshold, and \<15 were considered non-cravers.

Trial Locations

Locations (2)

OHSU Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States