- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02266017
Mobile Pain Coping Skills Training for Cancer Pain
An Accessible Mobile Health Behavioral Intervention For Cancer Pain
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).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile Pain Coping Skills Training
Coping Skills Training for pain will be delivered to participants using video-conferencing via a tablet computer.
|
|
Active Comparator: In person Pain Coping Skills Training
Participants will be provided with an in-person pain coping skills training intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain
Time Frame: Pre Study Intervention, Post Study Intervention & 3-month follow-up after post intervention
|
Brief Pain Inventory
|
Pre Study Intervention, Post Study Intervention & 3-month follow-up after post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tamara J Somers, PhD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00054792
- Research Scholars Grant (Other Grant/Funding Number: American Cancer Society)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mobile Pain Coping Skills Training
-
Duke UniversityCompletedPCST-Full (Pain Coping Skills Training) | PCST-BriefUnited States
-
National Health Promotion Associates, Inc.United States Air ForceCompletedSexual Behavior | Skills, Social | Skills, CopingUnited States
-
Saglik Bilimleri UniversitesiCompleted
-
Duke UniversityUniversity of Pittsburgh Medical CenterRecruitingGeneral Health Education | Coping Skills Training for Persistent Post-Surgical PainUnited States
-
University Hospitals Cleveland Medical CenterCompletedCoping Skills | Emotion RegulationUnited States
-
University of OsnabrueckCompletedStress | Coping Skills | Oxytocin
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA); American Academy of Child Adolescent...RecruitingCoping Skills | Family RelationshipUnited States
-
Klein Buendel, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of New...CompletedCoping Skills | Family RelationsUnited States
-
Marmara University Pendik Training and Research...Haydarpasa Numune Training and Research HospitalCompleted
-
University of PittsburghWithdrawn
Clinical Trials on Pain Coping Skills Training
-
Duke UniversityCompletedPCST-Full (Pain Coping Skills Training) | PCST-BriefUnited States
-
Duke UniversityCompletedStem Cell TransplantUnited States
-
University of North Carolina, Chapel HillPatient-Centered Outcomes Research InstituteCompletedOsteoarthritisUnited States
-
Duke UniversityAmerican Cancer Society, Inc.RecruitingPain | Advanced Solid TumorUnited States
-
Duke UniversityIcahn School of Medicine at Mount SinaiCompleted
-
Wake Forest University Health SciencesHonorHealth Research InstituteRecruitingCIPN - Chemotherapy-Induced Peripheral NeuropathyUnited States
-
Duke UniversityRecruitingBreast CancerUnited States
-
Wake Forest University Health SciencesNorthwestern University; Duke UniversityWithdrawnChronic Migraine, Headache
-
Virginia Commonwealth UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedKnee OsteoarthritisUnited States
-
Northwestern UniversityNational Cancer Institute (NCI); Duke UniversityRecruitingBreast Cancer | Arthralgia | Pain, ChronicUnited States