Pain Management for Head and Neck Cancer Survivors

Survivors of Head and Neck Cancer: Optimizing Pain Management

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Behavioral Intervention

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • OHSU Knight Cancer Institute
      • Contact: Kara Winchell; Phone Number: 503-220-8262; Email: kara.winchell@va.gov
      • Principal Investigator: Shannon M. Nugent, Ph.D.
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Portland VA Medical Center
      • Contact: Kara Winchell; Phone Number: 503-220-8262; Email: kara.winchell@va.gov
      • Principal Investigator: Shannon M. Nugent, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription opioid dose	Will be assessed via patient report.	Up to 2 months
Prescription opioid misuse	Will be assessed using the Chronic Opioid Misuse Measure (COMM). A score of 9 or greater is suggestive of current problematic drug-related behaviors.	Up to 2 months
Patient acceptability	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.	Up to 2 months

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; American Cancer Society, Inc.
• Investigators: Principal Investigator: Shannon M Nugent, Ph.D., OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: STUDY00019309 (Other Identifier: OHSU Knight Cancer Institute); NCI-2021-10801 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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