A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)

Not Applicable

Active, not recruiting

• Conditions: Hematologic Malignancy
• Interventions: Behavioral: Interval training; Behavioral: Psychiatric consult; Behavioral: Referral to Social Worker; Behavioral: Nutrition/diet evaluation

• Registration Number: NCT03823651
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to evaluate the feasibility and outcomes of a research pre- and peri-transplant optimization program (R-PPOP) to improve multiple domains of health including physical function, cognitive function, mental health, and diet and nutrition for patients planning to undergo or undergoing hematopoietic stem cell transplantation (HCT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Study Start: 2019-06-27
• Status Verified: 2022-09
• Primary Completion: 2022-10-27
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-20
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Plan to undergo an allogeneic hematopoietic stem cell transplant for any cancer or non-cancer illness within the next 6 months
• Age 18-80 years

Patient

Read More

Exclusion Criteria

• Both patient and caregiver are unable to read and follow directions in English (ok if only patient cannot read and follow directions in English as caregiver will be able to help).
• Any absolute contraindications to exercise:
• recent (< 6 months) acute cardiac event;
• unstable angina;
• uncontrolled dysrhythmias causing symptoms or hemodynamic compromise;
• symptomatic aortic stenosis;
• uncontrolled symptomatic heart failure;
• acute pulmonary embolus;
• acute myocarditis or pericarditis;
• suspected or known dissecting aneurism; or
• coronary artery disease.
• Functional impairment resulting in inability to exercise

Caregiver inclusion criteria

• Identified by patient as their primary caregiver
• Age 18-80 years

Caregiver exclusion criteria

• None

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caregiver	Referral to Social Worker	These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Patient	Nutrition/diet evaluation	These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Patient	Psychiatric consult	These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Caregiver	Nutrition/diet evaluation	These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Patient	Interval training	These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Patient	Referral to Social Worker	These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Caregiver	Psychiatric consult	These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions	6 months	Participants were asked to record or report their exercise sessions.

Trial Locations

Locations (1)

Duke University Adult Bone Marrow Transplant Clinic; 🇺🇸 Durham, North Carolina, United States