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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-10801 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00019309 | Other Identifier | OHSU Knight Cancer Institute |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Oregon Health and Science University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Attend Mobile Pain Coping Skills Training |
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| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Nugent, Ph.D. | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States | ||
| Portland VA Medical Center |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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Will be assessed by the University of Michigan Quality of Life Questionnaire. |
| Up to 2 months |
| 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 |
| Portland |
| Oregon |
| 97239 |
| United States |