Survivorship Post-HCT Optimization Program (S-POP)

Duke University

Status: Enrolling

Conditions: Hematologic Malignancy

Treatments: Behavioral: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05238376

Pro00110028

Details and patient eligibility

About

The purpose of this project is to investigate the effects of 12 weeks of high-intensity interval training (HIIT) and resistance training on several domains of health including physical function, cognitive function, mental health, and quality of life in patients who have undergone hematopoietic stem cell transplant (HCT). In addition, the project will determine the effects of 12 weeks of HIIT and resistance training on physical function, caregiver strain, mental health, and caregiver confidence in individuals who are providing care for patients undergoing HCT.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Inclusion Criteria:

1. ≥18 years old
2. English speaking
3. Within 90 ± 30 days post allogenic HCT

Caregiver Inclusion Criteria:

1. ≥18 years old
2. English speaking
3. Providing post-discharge care for the patient who has undergone HCT

Patient and Caregiver Exclusion Criteria:

1. Have an absolute contraindication to exercise including a recent acute cardiac event (<6 months), unstable angina, uncontrolled dysthymias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspects or known dissecting aneurism, or coronary artery disease.
2. In addition to these absolute contraindications, the patient and caregiver will complete cardiopulmonary exercise testing (CPET) where the heart rate and heart rhythm will be monitored via a 12-lead ECG before, during, and after the test. The results from the CPET will be reviewed by a physician before the subject is cleared to participate in the HIIT and resistance training program. If the participant is not cleared by the physician following the CPET, then the patient and his or her caregiver will not be eligible to participate in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Patient

Experimental group

Description:

These are patients who are 90 (±30) days post-allogeneic hematopoietic stem cell transplant. Patients will complete 12 weeks of exercise training. Patients will also complete assessments to evaluate physical function, cognitive function, mental health, social support, nutrition and diet, symptoms, quality of life, and financial status. They will use devices to capture activity data and vital signs. They will collect bio-specimens to assess microbiota and biomarkers.

Treatment:

Behavioral: Exercise training

Caregiver

Experimental group

Description:

These are the assigned caregivers for the transplant patients. Caregivers will complete 12 weeks of exercise training. Caregivers will also complete assessments to evaluate physical function, caregiver support, and physical activity and exercise. They will collect bio-specimens to assess microbiota.

Treatment:

Behavioral: Exercise training