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Completed

NCT Number: NCT05208554

Physical Activity Intervention for Hematopoietic Cell Transplant Recipients and Caregivers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Pheonix, Arizona, 85054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

- Caregivers:

  • Not married to or partnered/ cohabiting with the patient.
  • Unable to participate in a walking program.

Treatment and study plan

Integrated health counseling and step prescription

Behavioral

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

Primary outcomes

  1. Treatment adherence

    Time frame: 8 weeks

    Percentage of couples attending all 8 intervention sessions

  2. 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

  1. Treatment satisfaction

    Time frame: 90-100 days post-transplant

    Multi-Dimensional Treatment Satisfaction Measure

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Arizona State University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
May 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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