Halt Aging in Survivors of Blood Cancers (HALTAging-1)
Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Taylor Johnson
- Phone Number: 402-559-4596
- Email: taylora.johnson@unmc.edu
Study Contact Backup
- Name: IIT OFFICE
- Phone Number: 402-559-4596
- Email: iitoffice@unmc.edu
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68008
- Recruiting
- University of Nebraska Medical Center
-
Principal Investigator:
- Vijaya Bhatt, MBBS
-
Contact:
- IIT Office IIT Office
- Phone Number: 402-559-4596
- Email: IITOffice@unmc.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥50 years
- A history of hematological malignancy
- Participants must be able to and willingly give informed consent
Exclusion Criteria:
- Patients receiving intensive induction or consolidation chemotherapy. Maintenance chemotherapy, or lower-intensity chemotherapy for an indolent hematological malignancy is allowed.
- Neurodegenerative disease (e.g. Alzheimer's dementia), stroke, or uncontrolled psychotic disorders (e.g. schizophrenia or bipolar disorder) in the past 3 months if those disorders are considered significant enough to impair participation in the study.
- Illnesses such as clinical evidence of decompensated heart failure, unstable angina, or orthopedic or neuromuscular disorders that could limit safe participation in aerobic exercise.
- Cardiopulmonary exercise test results that preclude safe exercise (e.g., life-threatening arrhythmia, balance difficulties, peak VO2 <10 ml/kg/min).
- Estimated life expectancy of less than 6 months (that precludes assessment of study primary endpoint).
- Self-reported pregnancy or the possibility of pregnancy.
- Participants who do not plan to follow up at the participating center.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Intervention Arm: Exercise + Behavioral Coaching
Intervention arm incorporating virtually supervised moderate-intensity aerobic exercise and behavioral intervention/coaching to improve adherence
|
Intervention arm incorporating virtually supervised moderate-intensity aerobic exercise and behavioral intervention/coaching to improve adherence
Access to a virtual exercise platform that provides exercise classes and educational sessions for older survivors of blood cancer
|
|
Active Comparator: Enhanced Usual Care-Virtual Gym
Participants will receive access to a virtual exercise platform, and educational sessions but will not receive behavioral coaching
|
Access to a virtual exercise platform that provides exercise classes and educational sessions for older survivors of blood cancer
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of participants who adhered to the exercise regimen at 6-months post enrollment.
Time Frame: 6 Months from start of program
|
Participants achieving at least 120 minutes per week of moderate-intensity aerobic exercise, measured using Polar heart rate monitor data and exercise diaries.
|
6 Months from start of program
|
|
Percentage of participants who adhered to the exercise regimen at 12-months post enrollment.
Time Frame: 12 Months from start of program.
|
Participants achieving at least 120 minutes per week of moderate-intensity aerobic exercise, measured using Polar heart rate monitor data and exercise diaries to assess sustainability of adherence.
|
12 Months from start of program.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Function (6- Minute Walk Test Distance)
Time Frame: 6 months from randomization
|
Distance covered during the 6-minute walk test (6MWT) to assess physical function.
|
6 months from randomization
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Function Maximal Oxygen Consumption (VO₂ max)
Time Frame: 6 months from randomization
|
Maximal oxygen consumption measured during cardiopulmonary exercise testing (CPET)
|
6 months from randomization
|
|
Neuro-QOL Cognition Function Short Form Score
Time Frame: 6 months from randomization
|
Subjective cognitive function assessed using the Neuro-QOL v2.0 Cognition Function Short Form
|
6 months from randomization
|
|
Trail Making Test Performance
Time Frame: 6 months from randomization
|
Cognitive function assessed using Trail Making Test Parts A and B (TMT-A and TMT-B).
|
6 months from randomization
|
|
Controlled Oral Word Association Test Performance
Time Frame: 6 months from randomization
|
Cognitive function assessed using the Controlled Oral Word Association Test (COWAT).
|
6 months from randomization
|
|
EORTC QLQ-C30 Score
Time Frame: 6 months from randomization
|
Health-related quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), version 3.0.
|
6 months from randomization
|
|
EQ-5D-5L Score
Time Frame: 6 months from randomization
|
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument.
|
6 months from randomization
|
|
Biological Age by Epigenetic Clock
Time Frame: 6 months from randomization
|
Change in biological age assessed using epigenetic clock biomarkers based on DNA methylation analysis.
|
6 months from randomization
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Vijaya Raj Bhatt, MBBS,MS, University of Nebraska
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Neoplasms by Site
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Leukemia, Myeloid, Acute
- Hemic and Lymphatic Diseases
- Leukemia
- Leukemia, Myeloid
- Hematologic Neoplasms
- Leukemia, Lymphoid
- Multiple Myeloma
- Lymphoma, Non-Hodgkin
- Hodgkin Disease
- Leukemia, Monocytic, Acute
Other Study ID Numbers
Other Study ID Numbers
- 606-25-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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