NCT02266017

Mobile Pain Coping Skills Training for Cancer Pain

Completed NA Last updated 7 August 2023

What this trial tests

NA trial testing Pain Coping Skills Training in Mobile Pain Coping Skills Training in 178 participants. Completed in 21 March 2018.

Timeline

6 October 2014

Primary endpoint
21 March 2018

21 March 2018

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	178
Start date	6 October 2014
Primary completion	21 March 2018
Estimated completion	21 March 2018
Sites	1 location across United States

Drugs / interventions tested

• Pain Coping Skills Training

Conditions studied

• Mobile Pain Coping Skills Training — all drugs for Mobile Pain Coping Skills Training →
• In Person Pain Coping Skills Training — all drugs for In Person Pain Coping Skills Training →

Sponsor

Duke University

Who can join

18 and older, any sex, with Mobile Pain Coping Skills Training or In Person Pain Coping Skills Training. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A behavioral cancer pain intervention: A randomized noninferiority trial comparing in-person with videoconference delivery.
   Kelleher SA, Winger JG, Dorfman CS, Ingle KK, et al · · 2019 · cited 42× · PMID 31162756 · DOI 10.1002/pon.5141