Ignite Creation Date:
2024-05-06 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05208554
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2022-01-04
Brief Title:
Physical Activity Intervention for Hematopoietic Cell Transplant Recipients and Caregivers
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Feasibility and Acceptability of a Dyad-based Physical Activity Intervention for Hematopoietic Cell Transplant Recipients and Caregivers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
Levels of physical activity PA among cancer survivors are low yet PA may ameliorate effects of treatment Phillips et al 2014 We focus here on PA following the most intensive form of cancer treatment hematopoietic cell transplantation HCT with multiple sequelae including graft-versus-host disease and cardiovascular and pulmonary complications PA is diminished post-transplant Hacker Mjukian 2014 Morishita et al 2017 This decrease is associated with poorer physical functioning Bennett et al 2016 in turn associated with greater mortality Wood et al 2016 Moderate exercise has been deemed safe for HCT patients Wiskemann et al 2014 and PA interventions feasible Hacker Mjukian 2014 Findings regarding efficacy are mixed largely due to heterogeneity of intervention components and outcomes Liu et al 2009 Persoon et al 2013 All PA interventions in the HCT setting have focused entirely on patients ignoring an opportunity to synergistically engage and benefit the caregiver a 247 role requiring provision of medical logistical and emotional support Distress is common among HCT caregivers and their own health promotion is neglected Applebaum et al 2016 In addition the patient-caregiver relationship can be compromised and communication patterns disrupted Langer et al 2009 Guided by interdependence Kelley et al 1983 and communal coping Lyons et al 1998 perspectives our 8-session PA intervention provides training in communication skills and behavior change techniques to help patient-caregiver dyads support one another in PA Previous testing with a sample of breast cancer and prostate cancer survivors and caregivers demonstrated feasibility but relied solely on self-reported PA and self-determined PA goals Porter et al 2018 We have adapted this protocol for HCT and will use a wearable device a Fitbit tracker to objectively monitor PA and to provide participants with weekly individualized step goals
Specific aims are to 1 determine feasibility of adherence to a dyad-based PA intervention of sessions attended and Fitbit wear adherence for HCT recipients and caregivers 15 dyads using a single-group pre-post design 2 determine acceptability of the intervention dimensions of treatment satisfaction and 3 describe patterns of change in PA and communal coping from baseline to follow-up Findings will inform the design of a randomized controlled trial to test efficacy of the intervention to improve physical endurance and relational well-being
Specific aims are to 1 determine feasibility of adherence to a dyad-based PA intervention of sessions attended and Fitbit wear adherence for HCT recipients and caregivers 15 dyads using a single-group pre-post design 2 determine acceptability of the intervention dimensions of treatment satisfaction and 3 describe patterns of change in PA and communal coping from baseline to follow-up Findings will inform the design of a randomized controlled trial to test efficacy of the intervention to improve physical endurance and relational well-being
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2022-02761 | REGISTRY | NCI | None |