CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Interval training +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03823651
NCT03823651N/ACompleted

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

Duke University·interventional·Posted Jan 30, 2019·Updated Sep 27, 2024

In Brief

A clinical study evaluating Interval training, Psychiatric consult, and 2 other interventions for Hematologic Malignancy. Completed, enrolled 29 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 30, 2019
Enrollment StartMay 6, 2019
Primary CompletionOct 27, 2022
Study CompletionApr 27, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.4 years ago

Interventions

Interval trainingbehavioral

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.

Psychiatric consultbehavioral

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.

Nutrition/diet evaluationbehavioral

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

Referral to Social Workerbehavioral

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