Ignite Creation Date:
2024-05-06 @ 2:10 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01984671
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2013-10-31
Brief Title:
Mobile Pain Coping Skills Training for Stem Cell Transplant Patients
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Home-Based Tablet Computer Pain Coping Skills Following Stem Cell Transplant
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Persistent pain is a major challenge for patients who undergo hematopoietic stem cell transplant HSCT and is related to more fatigue more physical disability poorer quality of life and poorer medical adherence There is a need to examine strategies for managing pain in HSCT patients that can complement existing analgesic regimens Strong evidence suggests that cognitive and behavioral factors play an important role in HSCT patients ability to manage their pain The investigator has found that HSCT patients having low levels of confidence ie self-efficacy in their ability to control pain and high use of maladaptive coping strategies ie pain catastrophizing experience increased pain and disability A psychosocial intervention that modifies patients cognitive and behavioral pain coping strategies may benefit HSCT patients Protocols particularly Pain Coping Skills Training PCST have been developed for reducing pain and improving quality of life in patients with persistent pain However HSCT patients with persistent pain face a number of unique challenges that must be considered when applying a PCST protocol The investigator proposes to develop and test a Mobile Health Pain Coping Skills mPCST protocol for HSCT patients with persistent pain to meet the challenges of HSCT patients with pain as they transition from hospital based care to their home environment The first aim of this study is to use an iterative development model to design a mPCST intervention protocol for HSCT patients that targets increasing self-efficacy for pain control and decreasing pain catastrophizing The study team will use focus groups with patients and HSCT providers to guide development along with user testing with HSCT patients having pain The second aim of this study is to use a small randomized controlled trial to examine the feasibility acceptability and engagement in the developed mPCST protocol The third aim is to obtain an estimate of the effect size of the developed mPCST protocol on decreased pain pain disability physical disability and adherence to post-transplant lifestyle recommendations impacted by pain when compared to a standard care control condition Proposed innovative features of the mPCST protocol that will be developed include extensive input from PCST and HSCT experts and HSCT patients with pain an initial session prior to discharge with subsequent sessions occurring at home via video-conferencing incorporation of strategies to decrease the impact of pain on adherence to critical post-transplant lifestyle recommendations a real-time daily assessment system with subsequent tailored feedback If the developed mPCST protocol demonstrates feasibility acceptability engagement and promising effect sizes to influence pain and other indices of quality of life a larger NIH grant will be sought to examine this protocol in a larger sample of patients test the protocol against an active treatment and investigate a broader array of outcomes eg medication adherence This mPCST protocol could also be examined in other patient populations with pain facing similar challenges eg live far from medical center travel limitations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None