Hematologic MalignancyNCT03823651

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

A study testing Interval training, Psychiatric consult and Nutrition/diet evaluation in people with Hematologic Malignancy, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hematologic Malignancy
What is being tested?: Interval training, Psychiatric consult and Nutrition/diet evaluation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: 6 May 2019to 27 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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 locations and contacts

1 site in 1 country.

United States1 site

Duke University Adult Bone Marrow Transplant Clinic
Durham, North Carolina, 27705

Other trials in United States

About this study

Conditions: Hematologic Malignancy
Being tested: Interval training, Psychiatric consult, Nutrition/diet evaluation, Referral to Social Worker
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interval trainingBehavioural
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 consultBehavioural
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 evaluationBehavioural
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 WorkerBehavioural
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

Study groups in NCT03823651
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Psychiatric consult; Behavioral: Nutrition/diet evaluation; Behavioral: Referral to Social Worker

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 May 201927 Apr 2024

First posted30 Jan 2019
Study start6 May 2019
Primary completion27 Oct 2022
Study completion27 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03823651
Sponsor's protocol ID: Pro00092963
Status last verified: Sep 2024
First submitted: 28 Jan 2019
Last updated: 27 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm

All Hematologic Malignancy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)
ClinicalTrials.gov ID: NCT03823651
Acronym / sponsor ID: Pro00092963
Conditions: Hematologic Malignancy
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 6 May 2019 (actual)
Primary completion: 27 Oct 2022 (actual)
Study completion: 27 Apr 2024 (actual)
First posted: 30 Jan 2019 (actual)
Results: Posted 27 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Patient	Experimental	Behavioral: Interval training, Behavioral: Psychiatric consult, Behavioral: Nutrition/diet evaluation, Behavioral: Referral to Social WorkerThese are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Caregiver	Experimental	Behavioral: Psychiatric consult, Behavioral: Nutrition/diet evaluation, Behavioral: Referral to Social WorkerThese are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interval trainingPatients 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.	Behavioural	Patient
Psychiatric consultSubjects 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.	Behavioural	Caregiver, Patient
Nutrition/diet evaluationPG-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	Behavioural	Caregiver, Patient
Referral to Social WorkerSubjects 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	Behavioural	Caregiver, Patient

Primary outcome

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

Results and safety

Results posted to the registry on 27 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patient	13	7
Caregiver	11	5

Primary outcome: Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Patient n = 9
Value	9

Population analysed: 13 patients were prescribed the HIIT intervention, but only 9 consistently recorded sessions throughout the duration of the study.

Adverse events

Time frame: Adverse event data was collected for participants from enrollment through 1 year post-transplant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patient	0 of 13 (0%)	2 of 13 (15.4%)	5 of 13
Caregiver	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hematologic Malignancy

RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anthony Sung, MD principal investigator

Duke Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Interval training, Psychiatric consult and Nutrition/diet evaluation in people with Hematologic Malignancy, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03823651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.