Pain Management for Head and Neck Cancer Survivors

OHSU Knight Cancer Institute33 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Head and Neck Carcinoma

Interventions

Behavioral InterventionBEHAVIORAL

Attend Mobile Pain Coping Skills Training

Quality-of-Life AssessmentOTHER

Ancillary studies

Questionnaire AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

OHSU Knight Cancer Institute

Portland, Oregon, United States

Portland VA Medical Center

Portland, Oregon, United States

Outcomes

Primary Outcomes

Pain-interference

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

Time frame: Up to 2 months

Depression

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.

Time frame: Up to 2 months

Pain coping self-efficacy

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

Time frame: Up to 2 months

Secondary Outcomes

Substance use

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.

Time frame: Up to 2 months

Head and neck cancer related quality of life

Will be assessed by the University of Michigan Quality of Life Questionnaire.

Time frame: Up to 2 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.