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Clinical Trials/NCT05208554
NCT05208554
Completed
Not Applicable

Feasibility and Acceptability of a Dyad-based Physical Activity Intervention for Hematopoietic Cell Transplant Recipients and Caregivers

Mayo Clinic1 site in 1 country34 target enrollmentFebruary 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hematopoietic Cell Transplant
Sponsor
Mayo Clinic
Enrollment
34
Locations
1
Primary Endpoint
Treatment adherence
Status
Completed
Last Updated
11 months ago

Overview

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 24/7 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.

Registry
clinicaltrials.gov
Start Date
February 3, 2022
End Date
December 7, 2022
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nandita Khera

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Treatment adherence

Time Frame: 8 weeks

Percentage of couples attending all 8 intervention sessions

Fitbit adherence

Time Frame: 7 days

Percentage of participants providing valid wear data 4 of 7 days/ week during assessment periods (device worn \>=10 hours/ day)

Secondary Outcomes

  • Treatment satisfaction(90-100 days post-transplant)

Study Sites (1)

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