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Pain Management for Head and Neck Cancer Survivors

Sponsor
OHSU Knight Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05115825
Collaborator
American Cancer Society, Inc. (Other), Oregon Health and Science University (Other)
30
Enrollment
2
Locations
1
Arm
57.2
Anticipated Duration (Months)
15
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral Intervention
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
 N/A

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Survivors of Head and Neck Cancer: Optimizing Pain Management
Actual Study Start Date :
Mar 27, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Supportive care (Mobile Pain Coping Skills Training)

Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks.

Behavioral: Behavioral Intervention
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

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. Pain coping self-efficacy [Up to 2 months]

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

    Secondary Outcome Measures

    1. 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.

    2. Head and neck cancer related quality of life [Up to 2 months]

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

    Other Outcome Measures

    1. Prescription opioid dose [Up to 2 months]

      Will be assessed via patient report.

    2. Prescription opioid misuse [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OHSU Knight Cancer Institute Portland Oregon United States 97239
    2 Portland VA Medical Center Portland Oregon United States 97239

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Shannon M Nugent, Ph.D., OHSU Knight Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shannon Nugent, Ph.D., Principal Investigator, OHSU Knight Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05115825
    Other Study ID Numbers:
    • STUDY00019309
    • NCI-2021-10801
    • STUDY00019309
    First Posted:
    Nov 10, 2021
    Last Update Posted:
    May 31, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Head and Neck Neoplasms

    Study Results

    No Results Posted as of May 31, 2022