Pain Management for Head and Neck Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Survivors of Head and Neck Cancer: Optimizing Pain Management

Conditions
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Head and Neck Carcinoma

Intervention / Treatment
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* Behavioral: Behavioral Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (Mobile Pain Coping Skills Training)<br>Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks. | Behavioral: Behavioral Intervention<br>* Attend Mobile Pain Coping Skills Training<br>* Other names: Behavioral Treatments;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 2 months | 
| Pain coping self-efficacy | Will be assessed by the Chronic Pain Self-Efficacy Scale. | Up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 2 months | 
| Head and neck cancer related quality of life | Will be assessed by the University of Michigan Quality of Life Questionnaire. | Up to 2 months |