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Completed

NCT Number: NCT05115825

Pain Management for Head and Neck Cancer Survivors

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.

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Key information

Conditions

Head and Neck Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OHSU Knight Cancer Institute, Portland, Oregon, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral intervention

Behavioral

Attend Mobile Pain Coping Skills Training

Other names: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. Pain coping self-efficacy

    Time frame: Up to 2 months

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

Secondary outcomes

  1. Substance use

    Time frame: 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.

  2. Head and neck cancer related quality of life

    Time frame: Up to 2 months

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

Other outcomes

  1. Prescription opioid dose

    Time frame: Up to 2 months

    Will be assessed via patient report.

  2. Prescription opioid misuse

    Time frame: Up to 2 months

    Will be assessed using the Chronic Opioid Misuse Measure (COMM). A score of 9 or greater is suggestive of current problematic drug-related behaviors.

  3. Patient acceptability

    Time frame: Up to 2 months

    Post-intervention, patients will be asked to rate satisfaction with the program, perception of utility with pain management, using a Likert-scale. Will inquire about patients' experiences participating in the intervention, perceived burden of participation, perception of the intervention utility, ease of use of the associated technology, and suggestions for improving the intervention.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • American Cancer Society, Inc.
  • Oregon Health and Science University

Registry information

Official study title

Survivors of Head and Neck Cancer: Optimizing Pain Management

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Nov 10, 2021
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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