Mobile Pain Coping Skills Training for Cancer Pain
Primary Purpose
Mobile Pain Coping Skills Training, In Person Pain Coping Skills Training
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Coping Skills Training
Sponsored by
About this trial
This is an interventional treatment trial for Mobile Pain Coping Skills Training focused on measuring pain, coping, mhealth, cancer
Eligibility Criteria
Inclusion Criteria:
- Life expectancy of 6 or more months
- Clinical pain rating of 3/10
- Primary diagnosis of breast, lung, prostate, or colorectal cancer in last year
Exclusion Criteria:
- Cognitive impairment
- Metastases to brain
- Treatment for serious psychological disorder in last 6 months
- Current or past engagement in pain coping skills training for cancer pain
Sites / Locations
- Duke Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile Pain Coping Skills Training
In person Pain Coping Skills Training
Arm Description
Coping Skills Training for pain will be delivered to participants using video-conferencing via a tablet computer.
Participants will be provided with an in-person pain coping skills training intervention
Outcomes
Primary Outcome Measures
Change in Pain
Brief Pain Inventory
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02266017
Brief Title
Mobile Pain Coping Skills Training for Cancer Pain
Official Title
An Accessible Mobile Health Behavioral Intervention For Cancer Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 6, 2014 (Actual)
Primary Completion Date
March 21, 2018 (Actual)
Study Completion Date
March 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain in cancer patients is estimated to be as high as 90% and results in physical and psychological disability. Behavioral interventions that increase patients' confidence in their ability to manage their pain have been shown to be beneficial. Behavioral interventions for cancer pain teach patients how their thoughts and feelings can influence their pain and specific strategies (e.g., relaxation) for decreasing cancer pain. However, despite guidelines recommending such interventions be used in the care of cancer patients with pain, they are not routinely used. A critical barrier to the use of behavioral interventions is that patients have difficulties attending appointments which are typically offered at the medical center during normal business hours. Mobile health (mHealth) technologies provide new opportunities to decrease such barriers. The investigators have developed a new mHealth approach that may increase the use of behavioral cancer pain interventions and ultimately lead to greater use of interventions that can decrease pain and disability.
The investigators propose to test an approach that uses mHealth technologies to deliver a behavioral cancer pain intervention to patients in their home using a tablet computer (e.g., iPad) and video-conferencing (e.g., Skype). The investigators will randomly assign 160 cancer patients with breast, lung, prostate, or colorectal cancer pain to receive either mHealth Pain Coping Skills Training system (mPCST) or to receive a traditional in-person pain coping skills training intervention protocol (PCST-trad) at the medical center. The investigators will test whether the mPCST is more accessible to patients than PCST-trad. The investigators expect that mPCST, compared to PCST-trad, will: a) be more feasible meaning that more patients will complete it in a timely manner; b) create less burden meaning it is easier for patients physically, emotionally, and financially to participate; c) increase engagement meaning that patients will practice skills more and have more understanding of the material; and d) be more overall acceptable to patients. the investigators also expect that patients who find this intervention more feasible, less burdensome, more engaging, and more acceptable will be more likely to experience decreased pain, physical disability, and psychological disability, and increased confidence in their ability to manage their pain.
The investigators' goal is to use mHealth technologies to facilitate wide-spread use of behavioral cancer pain interventions. Increased use of mHealth behavioral cancer pain interventions will particularly benefit patients living far from medical centers (e.g., rural), experiencing cancer-related physical challenges, and facing other practical barriers (e.g., transportation, work) to in-person interventions. These outcomes could lead to future work evidencing that mHealth behavioral interventions could be applied to other areas of quality of life in cancer patients (e.g., fatigue) and/or in other samples of patients with persistent pain (e.g., arthritis).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobile Pain Coping Skills Training, In Person Pain Coping Skills Training
Keywords
pain, coping, mhealth, cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Pain Coping Skills Training
Arm Type
Experimental
Arm Description
Coping Skills Training for pain will be delivered to participants using video-conferencing via a tablet computer.
Arm Title
In person Pain Coping Skills Training
Arm Type
Active Comparator
Arm Description
Participants will be provided with an in-person pain coping skills training intervention
Intervention Type
Behavioral
Intervention Name(s)
Pain Coping Skills Training
Primary Outcome Measure Information:
Title
Change in Pain
Description
Brief Pain Inventory
Time Frame
Pre Study Intervention, Post Study Intervention & 3-month follow-up after post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Life expectancy of 6 or more months
Clinical pain rating of 3/10
Primary diagnosis of breast, lung, prostate, or colorectal cancer in last year
Exclusion Criteria:
Cognitive impairment
Metastases to brain
Treatment for serious psychological disorder in last 6 months
Current or past engagement in pain coping skills training for cancer pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara J Somers, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mobile Pain Coping Skills Training for Cancer Pain
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