Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study

University of Nebraska

Status and phase: Not yet enrolling; Phase 2

Conditions: Hodgkin Lymphoma; Other Hematologic Condition; Multiple Myeloma; Non-hodgkin Lymphoma; Monocytic Leukemia; Myeloid Leukemia; Leukemia; Lymphoid Leukemia

Treatments: Behavioral: Virtual Gym Membership; Behavioral: Supervised Exercise and Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT07292272

606-25-FB

Details and patient eligibility

About

Older survivors of blood cancer are at a high risk of accelerated biological aging, which increases their risk of developing multiple aging-related conditions. Whereas physical exercise can improve overall health, older cancer survivors do not meet the recommended physical activity, highlighting the need to develop behavioral interventions to increase adherence. Several other knowledge gaps exist to implement exercise interventions in older survivors of blood cancer; the dose and duration of exercise necessary to slow biological aging in older blood cancer survivors remain unknown. To bridge these gaps in knowledge, we have designed a Phase 2 randomized control trial to test the effects of behavioral and exercise interventions on various outcomes.

Enrollment: 180 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥50 years
2. A history of hematological malignancy
3. Participants must be able to and willingly give informed consent

Exclusion criteria

1. Patients receiving intensive induction or consolidation chemotherapy. Maintenance chemotherapy, or lower-intensity chemotherapy for an indolent hematological malignancy is allowed.
2. 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.
3. Illnesses such as clinical evidence of decompensated heart failure, unstable angina, or orthopedic or neuromuscular disorders that could limit safe participation in aerobic exercise.
4. Cardiopulmonary exercise test results that preclude safe exercise (e.g., life-threatening arrhythmia, balance difficulties, peak VO2 <10 ml/kg/min).
5. Estimated life expectancy of less than 6 months (that precludes assessment of study primary endpoint).
6. Participants who do not plan to follow up at the participating center.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Intervention Arm-Supervised

Experimental group

Description:

intervention arm incorporating virtually supervised moderate-intensity aerobic exercise and behavioral intervention/coaching to improve adherence

Treatment:

Behavioral: Supervised Exercise and Coaching

Enhanced Usual Care-Virtual Gym

Active Comparator group

Description:

enhanced usual care arm, where survivors will get access to virtual gym membership only.

Treatment:

Behavioral: Virtual Gym Membership