Hematological Malignancy, Leukemia, Lymphoid Leukemia, Monocytic Leukemia, Multiple Myeloma, Myeloid Leukemia, Non-hodgkin Lymphoma, Other Hematologic Condition
Conditions
Keywords
Hodgkin Lymphoma, Leukemia, Lymphoid Leukemia, Multiple Myeloma, Myeloid Leukemia, Monocytic Leukemia, Non-hodgkin Lymphoma, Other Hematologic Condition, Epigenetic clock, Biological aging, Quality of life, Blood cancer survivors
Brief summary
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.
Interventions
BEHAVIORALBehavioral Coaching Intervention
Intervention arm incorporating virtually supervised moderate-intensity aerobic exercise and behavioral intervention/coaching to improve adherence
BEHAVIORALVirtual Exercise Platform
Access to a virtual exercise platform that provides exercise classes and educational sessions for older survivors of blood cancer
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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. Self-reported pregnancy or the possibility of pregnancy. 7. Participants who do not plan to follow up at the participating center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who adhered to the exercise regimen at 6-months post enrollment. | 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. |
| Percentage of participants who adhered to the exercise regimen at 12-months post enrollment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function (6- Minute Walk Test Distance) | 6 months from randomization | Distance covered during the 6-minute walk test (6MWT) to assess physical function. |
Countries
United States
Contacts
CONTACTTaylor Johnson
CONTACTIIT OFFICE
PRINCIPAL_INVESTIGATORVijaya Raj Bhatt, MBBS,MS
University of Nebraska
Outcome results
None listed