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

Duke University

Status: Completed

Conditions: Hematologic Malignancy

Treatments: Behavioral: Nutrition/diet evaluation; Behavioral: Referral to Social Worker; Behavioral: Interval training; Behavioral: Psychiatric consult

Study type: Interventional

Funder types: Other

Identifiers

NCT03823651

Pro00092963

Details and patient eligibility

About

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).

Enrollment: 29 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Patient

Experimental group

Description:

These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.

Treatment:

Behavioral: Psychiatric consult

Behavioral: Interval training

Behavioral: Referral to Social Worker

Behavioral: Nutrition/diet evaluation

Caregiver

Experimental group

Description:

These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.

Treatment:

Behavioral: Psychiatric consult

Behavioral: Referral to Social Worker

Behavioral: Nutrition/diet evaluation