Pain Management for Head and Neck Cancer Survivors

Head and Neck Carcinoma Clinical Trial

Official title:

Survivors of Head and Neck Cancer: Optimizing Pain Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05115825
• Other study ID #: STUDY00019309
• Secondary ID: NCI-2021-10801ST
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Head and Neck Neoplasms

Intervention

Behavioral:
• Behavioral Intervention
Attend Mobile Pain Coping Skills Training

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	American Cancer Society, Inc., Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prescription opioid dose	Will be assessed via patient report.	Up to 2 months
Other	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
Other	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
Primary	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
Primary	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
Primary	Pain coping self-efficacy	Will be assessed by the Chronic Pain Self-Efficacy Scale.	Up to 2 months
Secondary	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
Secondary	Head and neck cancer related quality of life	Will be assessed by the University of Michigan Quality of Life Questionnaire.	Up to 2 months