Halt Aging in Survivors of Blood Cancers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥50 years

A history of hematological malignancy

Participants must be able to and willingly give informed consent

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Behavioral Coaching Intervention

    Behavioral

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

  • Virtual Exercise Platform

    Behavioral

    Access to a virtual exercise platform that provides exercise classes and educational sessions for older survivors of blood cancer

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Intervention Arm: Exercise + Behavioral CoachingExperimental treatment 2 interventions
Group B: Enhanced Usual Care-Virtual GymActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants who adhered to the exercise regimen at 6-months post enrollment.

Participants achieving at least 120 minutes per week of moderate-intensity aerobic exercise, measured using Polar heart rate monitor data and exercise diaries.

Time frame
6 Months from start of program
2

Percentage of participants who adhered to the exercise regimen at 12-months post enrollment.

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.

Time frame
12 Months from start of program.

Secondary outcomes

1

Physical Function (6- Minute Walk Test Distance)

Distance covered during the 6-minute walk test (6MWT) to assess physical function.

Time frame
6 months from randomization

Other outcomes

1

Physical Function Maximal Oxygen Consumption (VO₂ max)

Maximal oxygen consumption measured during cardiopulmonary exercise testing (CPET)

Time frame
6 months from randomization
2

Neuro-QOL Cognition Function Short Form Score

Subjective cognitive function assessed using the Neuro-QOL v2.0 Cognition Function Short Form

Time frame
6 months from randomization
3

Trail Making Test Performance

Cognitive function assessed using Trail Making Test Parts A and B (TMT-A and TMT-B).

Time frame
6 months from randomization
4

Controlled Oral Word Association Test Performance

Cognitive function assessed using the Controlled Oral Word Association Test (COWAT).

Time frame
6 months from randomization

Sponsors and contacts

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