Pain Management for Head and Neck Cancer Survivors

NCT05115825 | Completed

• 2 other identifiers: STUDY00019309NCI-2021-10801
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Substance use

  Up to 2 months

• Head and neck cancer related quality of life

  Up to 2 months

Other Outcomes (3)

• Prescription opioid dose

  Up to 2 months

• Prescription opioid misuse

  Up to 2 months

• Patient acceptability

  Up to 2 months

Study Arms (1)

Supportive care (Mobile Pain Coping Skills Training)

EXPERIMENTAL

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

Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Behavioral Intervention BEHAVIORAL

Attend Mobile Pain Coping Skills Training

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Supportive care (Mobile Pain Coping Skills Training)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (Mobile Pain Coping Skills Training)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (Mobile Pain Coping Skills Training)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shannon Nugent, Ph.D.

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 10, 2021
• Study Start: April 1, 2019
• Primary Completion: October 30, 2024
• Study Completion: May 16, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-01

Locations

US (2)