Mates in Motion: Feasibility and Acceptability of a Couple-Based Physical Activity Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
This clinical trial tests how well a couple-based physical activity (PA) intervention, Mates in Motion, works in patients undergoing hematopoietic cell transplantation (HCT) or chimeric antigen receptor T-cell therapy (CART) and their care giving partners to be more physically active. Mates in Motion provides training in communication skills and behavior change techniques to help HCT patient-caregiver dyads support one another in adoption and maintenance of PA. This study may help researchers determine if a couple-based PA intervention improves PA, physical endurance and global physical health among patient-care giver dyads undergoing HCT or CART.
详细描述
PRIMARY OBJECTIVES:
I. To determine feasibility of recruitment, adherence, and retention of a couple-based PA intervention in a pilot randomized controlled trial (RCT).
II. Determine acceptability of the intervention (multiple dimensions of treatment satisfaction).
III. Describe changes in PA, physical endurance, and global physical health from baseline to follow-up as a function of randomized condition.
OUTLINE: Patient-caregiver dyads are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •PATIENTS: Age 18 years or older
- •PATIENTS: Scheduled to receive an autologous or allogeneic hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)-T cell therapy
- •PATIENTS: Able to speak and comprehend English
- •PATIENTS: Being married or in a committed (self-defined) cohabiting same- or opposite-sex relationship
- •PATIENTS: Physician-approved for a walking program
- •CAREGIVERS: Age 18 years or older
- •CAREGIVERS: Able to speak and comprehend English
- •CAREGIVERS: Married to or in a committed, cohabiting, same- or opposite-sex relationship with the patient
- •CAREGIVERS: Able to participate in a walking program
排除标准
- •None per se beyond the converse of the inclusions listed above, for example, age younger than 18 years and non-partnered
研究组 & 干预措施
Arm I (Mates in Motion)
Dyads participate in the Mates in Motion program consisting of weekly sessions to train couples in the use of communal coping strategies to support one another in achieving PA goals and skill building focus on instruction and practice in effective communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA over 8 weeks. Patient-partner dyads receive weekly step-count goals, complete walk-tests and questionnaires and wear an Actigraph device and Garmin activity tracker on study.
干预措施: Exercise Counseling (Other)
Arm I (Mates in Motion)
Dyads participate in the Mates in Motion program consisting of weekly sessions to train couples in the use of communal coping strategies to support one another in achieving PA goals and skill building focus on instruction and practice in effective communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA over 8 weeks. Patient-partner dyads receive weekly step-count goals, complete walk-tests and questionnaires and wear an Actigraph device and Garmin activity tracker on study.
干预措施: Exercise Intervention (Other)
Arm I (Mates in Motion)
Dyads participate in the Mates in Motion program consisting of weekly sessions to train couples in the use of communal coping strategies to support one another in achieving PA goals and skill building focus on instruction and practice in effective communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA over 8 weeks. Patient-partner dyads receive weekly step-count goals, complete walk-tests and questionnaires and wear an Actigraph device and Garmin activity tracker on study.
干预措施: Medical Device Usage and Evaluation (Other)
Arm I (Mates in Motion)
Dyads participate in the Mates in Motion program consisting of weekly sessions to train couples in the use of communal coping strategies to support one another in achieving PA goals and skill building focus on instruction and practice in effective communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA over 8 weeks. Patient-partner dyads receive weekly step-count goals, complete walk-tests and questionnaires and wear an Actigraph device and Garmin activity tracker on study.
干预措施: Physical Performance Testing (Other)
Arm I (Mates in Motion)
Dyads participate in the Mates in Motion program consisting of weekly sessions to train couples in the use of communal coping strategies to support one another in achieving PA goals and skill building focus on instruction and practice in effective communication, with emphases on adaptive speaking, responsive listening, and joint decision-making and problem-solving around PA over 8 weeks. Patient-partner dyads receive weekly step-count goals, complete walk-tests and questionnaires and wear an Actigraph device and Garmin activity tracker on study.
干预措施: Questionnaire Administration (Other)
Arm II (usual care)
Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Garmin activity tracker at the end of the study.
干预措施: Best Practice (Other)
Arm II (usual care)
Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Garmin activity tracker at the end of the study.
干预措施: Medical Device Usage and Evaluation (Other)
Arm II (usual care)
Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Garmin activity tracker at the end of the study.
干预措施: Physical Performance Testing (Other)
Arm II (usual care)
Patient-partner dyads wear an Actigraph device, compete walk-tests and questionnaires on study. Dyads receive usual care on study. Dyads receive a Garmin activity tracker at the end of the study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Retention
时间窗: At 100 days post-hematopoietic cell transplant (HCT)
Will be assessed by the number of post-intervention follow-up assessments completed.
Observed recruitment
时间窗: At baseline
Will be assessed by the percentage of eligible patient-partner couples agreeing to participate
Intervention adherence
时间窗: 8 weeks
Will be assessed by the number of intervention sessions attended.
Actigraph wear adherence
时间窗: 8 weeks
Will be assessed by the number of valid wear days.
Garmin wear adherence
时间窗: 8 weeks
Will be assessed by the number of valid wear days.
次要结局
- Acceptability of the intervention(At 100 days post-hematopoietic cell transplant (HCT))