Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03859765
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2019-02-12
Brief Title:
In Person and mHealth Coping Skills Training for Symptom Management and Steps in Stem Cell Transplant Patients
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Development and Pilot Testing of a Hybrid In Person and mHealth Coping Skills Training Intervention for Symptom Management and Daily Steps in Stem Cell Transplant Patients
Status:
COMPLETED
Status Verified Date:
2022-09
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:
Symptoms-Steps
Brief Summary:
Hematopoietic stem cell transplant HCT is an aggressive treatment for life-threatening cancers HCT improves survival but most HCT patients experience significant physical disability which is exacerbated by persistent symptoms Pain fatigue and psychological distress are the most prevalent and debilitating symptoms HCT patients experience a significant increase in disability as their pain fatigue and distress increase This disability and symptom burden interferes with patients ability to engage in recommended physical activity that can improve disability symptoms and other outcomes Disability and symptoms also complicate an already challenging recovery course HCT patients return home often far from their medical team are restricted from normal activities and socially isolated These disability symptom and activity challenges increase the risk for post-transplant complications and may compromise life expectancy Teaching HCT patients to cope with symptoms and activity is critical to helping them increase activity and reduce disability Cognitive behavioral coping skills training protocols can enhance HCT patients ability to cope with symptoms pain fatigue distress that interfere with physical activity However the application of these protocols to HCT patients is limited by in person sessions delivery of sessions in a medical center setting andor lack of tailoring to HCT patients specific needs Mobile health mHealth technologies can improve and extend intervention strategies to cope with symptoms and physical activity upon return home Behavioral intervention strategies are needed to enable HCT patients to effectively cope with symptoms to improve their ability to engage in physical activity that can improve physical disability
The investigators aim to develop and test a combined coping skills training and activity coaching protocol that first is feasible and acceptable and second improves physical disability as well as pain fatigue distress and physical activity in HCT patients Specifically the investigators will develop and test an in-person and mHealth HCT Coping Skills Training for Symptom Management and Daily Steps HCT Symptoms and Steps intervention protocol To do this the investigators will develop a mobile app conduct focus groups complete user testing and conduct a small randomized controlled trial RCT to examine feasibility acceptability and outcome patterns suggesting intervention efficacy of the developed HCT Symptoms and Steps protocol Following the development phase of the study ie focus groups the investigators will conduct user testing with 10 cancer patients who have undergone HCT all 10 patients will receive the HCT Symptoms and Steps intervention Next the investigators will randomly assign 40 cancer participants who have undergone HCT and report pain fatigue and stress to receive either HCT Symptoms and Steps or HCT Education The investigators will test whether HCT Symptoms and Steps is feasible and acceptable to HCT patients and improves physical disability as well as other important outcomes The investigators expect that HCT Symptoms and Steps will be feasible and acceptable to HCT patients and compared to HCT Education will be more likely to lead to improvements in physical disability as well as pain fatigue distress physical activity and self-efficacy for symptom management
The investigators goal is to demonstrate the feasibility acceptability and positive impact of a hybrid in-person and mHealth coping skills training and activity coaching intervention that reduces physical disability by concurrently and synergistically decreasing symptom burden and increasing physical activity This project has the potential to lead to future research that can redesign existing modes of behavioral intervention delivery improve continuity and coordination of care and ultimately enhance patient outcomes
The investigators aim to develop and test a combined coping skills training and activity coaching protocol that first is feasible and acceptable and second improves physical disability as well as pain fatigue distress and physical activity in HCT patients Specifically the investigators will develop and test an in-person and mHealth HCT Coping Skills Training for Symptom Management and Daily Steps HCT Symptoms and Steps intervention protocol To do this the investigators will develop a mobile app conduct focus groups complete user testing and conduct a small randomized controlled trial RCT to examine feasibility acceptability and outcome patterns suggesting intervention efficacy of the developed HCT Symptoms and Steps protocol Following the development phase of the study ie focus groups the investigators will conduct user testing with 10 cancer patients who have undergone HCT all 10 patients will receive the HCT Symptoms and Steps intervention Next the investigators will randomly assign 40 cancer participants who have undergone HCT and report pain fatigue and stress to receive either HCT Symptoms and Steps or HCT Education The investigators will test whether HCT Symptoms and Steps is feasible and acceptable to HCT patients and improves physical disability as well as other important outcomes The investigators expect that HCT Symptoms and Steps will be feasible and acceptable to HCT patients and compared to HCT Education will be more likely to lead to improvements in physical disability as well as pain fatigue distress physical activity and self-efficacy for symptom management
The investigators goal is to demonstrate the feasibility acceptability and positive impact of a hybrid in-person and mHealth coping skills training and activity coaching intervention that reduces physical disability by concurrently and synergistically decreasing symptom burden and increasing physical activity This project has the potential to lead to future research that can redesign existing modes of behavioral intervention delivery improve continuity and coordination of care and ultimately enhance patient outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None