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临床试验/NCT05208554
NCT05208554已完成不适用

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

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
34
试验地点
2
主要终点
Treatment adherence

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Family-Focused Facilitated Fitness program

Experimental

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.

干预措施: Integrated health counseling and step prescription (Behavioral)

结局指标

主要结局

Treatment adherence

时间窗: 8 weeks

Percentage of couples attending all 8 intervention sessions

Fitbit adherence

时间窗: 7 days

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

次要结局

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

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nandita Khera

Principal Investigator

Mayo Clinic

研究点 (2)

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