Clinical trial NCT05115825: Pain Management for Head and Neck Cancer Survivors
Official title: Survivors of Head and Neck Cancer: Optimizing Pain Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Carcinoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Oregon Health and Science University
First posted: 2021-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain-interference
timeFrame: Up to 2 months
measure: Depression
timeFrame: Up to 2 months
measure: Pain coping self-efficacy
timeFrame: Up to 2 months
Secondary outcomes:
measure: Substance use
timeFrame: Up to 2 months
measure: Head and neck cancer related quality of life
timeFrame: Up to 2 months
Other outcomes:
measure: Prescription opioid dose
timeFrame: Up to 2 months
measure: Prescription opioid misuse
timeFrame: Up to 2 months
measure: Patient acceptability
timeFrame: Up to 2 months
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Shannon M Nugent, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: