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Mobile Pain Coping Skills Training for Cancer Pain

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ClinicalTrials.gov Identifier: NCT02266017
Recruitment Status : Completed
First Posted : October 16, 2014
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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).


Condition or disease Intervention/treatment Phase
Mobile Pain Coping Skills Training In Person Pain Coping Skills Training Behavioral: Pain Coping Skills Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Accessible Mobile Health Behavioral Intervention For Cancer Pain
Study Start Date : October 2014
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : March 21, 2018

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.
Behavioral: Pain Coping Skills Training
Active Comparator: In person Pain Coping Skills Training
Participants will be provided with an in-person pain coping skills training intervention
Behavioral: Pain Coping Skills Training



Primary Outcome Measures :
  1. Change in Pain [ Time Frame: Pre Study Intervention, Post Study Intervention & 3-month follow-up after post intervention ]
    Brief Pain Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266017


Locations
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United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Tamara J Somers, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02266017     History of Changes
Other Study ID Numbers: Pro00054792
Research Scholars Grant ( Other Grant/Funding Number: American Cancer Society )
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Keywords provided by Duke University:
pain
coping
mhealth
cancer
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms