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

NCT03823651 | Completed Results DMC

• 1 other identifier: Pro00092963
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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).

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions

  Participants were asked to record or report their exercise sessions.

  6 months

Other Outcomes (31)

• Measuring Changes in the Skin Flora (Microbiome) in Caregivers

  baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365

• Changes in Fecal Samples as Measured by 16s rRNA Sequencing in Caregivers

  baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365

• Caregiver Quality of Life as Assessed by the Caregiver Strain Questionnaire

  1 year

Study Arms (2)

Patient

EXPERIMENTAL

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

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

Caregiver

EXPERIMENTAL

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

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

Interventions

Interval training BEHAVIORAL

Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.

Patient

Psychiatric consult BEHAVIORAL

Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.

Caregiver; Patient

Nutrition/diet evaluation BEHAVIORAL

PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month

Caregiver; Patient

Referral to Social Worker BEHAVIORAL

Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up

Caregiver; Patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Identified by patient as their primary caregiver
• Age 18-80 years
• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Adult Bone Marrow Transplant Clinic

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Anthony Sung
• Organization: Duke University Medical Center

anthony.sung@duke.edu

919-668-1000

Study Officials

• Anthony Sung, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: May 6, 2019
• Primary Completion: October 27, 2022
• Study Completion: April 27, 2024
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)