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Physical Activity Intervention for Hematopoietic Cell Transplant Recipients and Caregivers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05208554
Enrollment
34
Registered
2022-01-26
Start date
2022-02-03
Completion date
2022-12-07
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Cell Transplant

Keywords

Physical Activity

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.

Interventions

BEHAVIORALIntegrated health counseling and step prescription

8 weekly dyad-based sessions with a health counselor to train couples in the use of communal coping strategies to support one another in achieving physical activity goals plus individualized step prescription based on remotely-monitored Fitbit-derived step counts the week prior

Sponsors

Arizona State University
CollaboratorOTHER
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Patients: * Scheduled to receive an autologous or allogeneic HCT. * Being married or in a committed cohabiting relationship. * English speaking and comprehending. * Physician approval to participate in a walking program. Inclusion Criteria - Caregivers: * Married to or in a cohabiting relationship with the patient. * Able to participate in a walking program.

Exclusion criteria

- Patients: * Not scheduled to receive an HCT or already post-HCT. * Unmarried or not in a committed cohabiting relationship. * Non-English speaking and comprehending. * Not medically approved to participate in walking program. * Enrolled in competing behavioral intervention.

Design outcomes

Primary

MeasureTime frameDescription
Treatment adherence8 weeksPercentage of couples attending all 8 intervention sessions
Fitbit adherence7 daysPercentage of participants providing valid wear data 4 of 7 days/ week during assessment periods (device worn \>=10 hours/ day)

Secondary

MeasureTime frameDescription
Treatment satisfaction90-100 days post-transplantMulti-Dimensional Treatment Satisfaction Measure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026