Head and Neck Carcinoma
Conditions
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.
Interventions
BEHAVIORALBehavioral Intervention
Attend Mobile Pain Coping Skills Training
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
OHSU Knight Cancer Institute
American Cancer Society, Inc.
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Pain coping self-efficacy | Up to 2 months | Will be assessed by the Chronic Pain Self-Efficacy Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Head and neck cancer related quality of life | Up to 2 months | Will be assessed by the University of Michigan Quality of Life Questionnaire. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShannon Nugent, Ph.D.
OHSU Knight Cancer Institute
Outcome results
None listed