Physical Activity Intervention for Hematopoietic Cell Transplant Recipients and Caregivers

Not Applicable

Active, not recruiting

• Conditions: Hematopoietic Cell Transplant
• Interventions: Behavioral: Integrated health counseling and step prescription

• Registration Number: NCT05208554
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-26
• Study Start: 2022-02-03
• Primary Completion: 2022-12-14
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Family-Focused Facilitated Fitness program	Integrated health counseling and step prescription	Couple-based physical activity intervention commencing 14 (+/-7) days post-transplant (8 sessions with a health counselor). Sessions 1-4 will train couples in the use of communal coping strategies to support one another in achieving PA goals. Skill building will focus on instruction and practice in adaptive communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA. Instruction and practice will focus specifically on communication about PA and working together (we versus me) to increase PA. Sessions 5-8 will afford check-in, review of PA progress, and troubleshooting any barriers to PA. All sessions will be dyad-based but will include delivery of individualized step goals for the next week using an adaptive approach and based on remotely-monitored Fitbit step data. Specifically, the 75th percentile rank of each participant's last 7 days of recorded days will serve as the step goal prescription for the next week.

Primary Outcome Measures

Name	Time	Method
Treatment adherence	8 weeks	Percentage of couples attending all 8 intervention sessions
Fitbit adherence	7 days	Percentage of participants providing valid wear data 4 of 7 days/ week during assessment periods (device worn \>=10 hours/ day)

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction	90-100 days post-transplant	Multi-Dimensional Treatment Satisfaction Measure

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Phoenix, Arizona, United States