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Pain Management for Head and Neck Cancer Survivors

Primary Purpose

Head and Neck Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU Knight Cancer InstituteRecruiting
  • Portland VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (Mobile Pain Coping Skills Training)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
Pain coping self-efficacy
Will be assessed by the Chronic Pain Self-Efficacy Scale.

Secondary Outcome Measures

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.
Head and neck cancer related quality of life
Will be assessed by the University of Michigan Quality of Life Questionnaire.

Full Information

First Posted
October 29, 2021
Last Updated
May 19, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
American Cancer Society, Inc., Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT05115825
Brief Title
Pain Management for Head and Neck Cancer Survivors
Official Title
Survivors of Head and Neck Cancer: Optimizing Pain Management
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
American Cancer Society, Inc., Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (Mobile Pain Coping Skills Training)
Arm Type
Experimental
Arm Description
Patients attend 5 sessions of Mobile Pain Coping Skills Training for 45 minutes each over 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Intervention Description
Attend Mobile Pain Coping Skills Training
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Pain-interference
Description
Will be assessed by Brief Pain Inventory. Will be assessed as 1-4=mild pain; 5-6 moderate pain; 7-10 severe pain.
Time Frame
Up to 2 months
Title
Depression
Description
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.
Time Frame
Up to 2 months
Title
Pain coping self-efficacy
Description
Will be assessed by the Chronic Pain Self-Efficacy Scale.
Time Frame
Up to 2 months
Secondary Outcome Measure Information:
Title
Substance use
Description
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.
Time Frame
Up to 2 months
Title
Head and neck cancer related quality of life
Description
Will be assessed by the University of Michigan Quality of Life Questionnaire.
Time Frame
Up to 2 months
Other Pre-specified Outcome Measures:
Title
Prescription opioid dose
Description
Will be assessed via patient report.
Time Frame
Up to 2 months
Title
Prescription opioid misuse
Description
Will be assessed using the Chronic Opioid Misuse Measure (COMM). A score of 9 or greater is suggestive of current problematic drug-related behaviors.
Time Frame
Up to 2 months
Title
Patient acceptability
Description
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.
Time Frame
Up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon M Nugent, Ph.D.
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Winchell
Phone
503-220-8262
Email
kara.winchell@va.gov
First Name & Middle Initial & Last Name & Degree
Shannon M. Nugent, Ph.D.
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Winchell
Phone
503-220-8262
Email
kara.winchell@va.gov
First Name & Middle Initial & Last Name & Degree
Shannon M. Nugent, Ph.D.

12. IPD Sharing Statement

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Pain Management for Head and Neck Cancer Survivors

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