Clinical trial NCT04265638: Exercise Intervention in Adolescent and Young Adult Cancer Survivors
Official title: One-on-one Exercise Program in Adolescent and Young Adult Cancer Survivors With a Certified Clinical Cancer Exercise Specialist
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long-term Effects Secondary to Cancer Therapy in Adults
Pediatric Cancer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 66
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Adolescent and young adult (AYA) survivors of cancer face a future of persistent medical issues across a wide spectrum of diseases One study examining health data from this cohort (ages 15-29) reported significantly higher rates of smoking, obesity, cardiovascular disease, hypertension, asthma, and poorer mental health among the cancer survivors when compared to healthy controls. Prescribed exercise has broad and far-reaching beneficial physiological effects that cut across multiple body systems and consistently improves emotional well-being, decreases fatigue and depression, and enhances quality of life. Although a growing body of evidence consistently demonstrates the physiological and psychological benefits of exercise interventions in adults with cancer, there are no studies examining the effects of individualized, prescribed, supervised exercise in pediatric, adolescent and young adult cancer survivors.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 15 and ≤ 39 years,
2. History of cancer
3. At least three months off of cytotoxic chemotherapy (note: hormone therapy is permitted)

Exclusion Criteria:

1. Evidence of significant liver dysfunction, congestive heart failure, cardiovascular disease
2. History of CNS tumor
3. Down's Syndrome
4. Unable to perform aerobic and/or strength exercises with full range of motion (limb immobilization, limb amputation, or surgical complications.
5. Neurological disorder
6. Baseline exercise of 30 minutes per day three times a week already being performed.

Primary outcomes:
measure: Change of the Participant Evaluation of Feasibility and Acceptability Questionnaire
timeFrame: weeks 12 and 24
measure: Change of Balance Assessment
timeFrame: baseline, weeks 6, 12, and 24
measure: Change of Cardiovascular Systems - VO2 Peak (mL·kg-1·min-1)
timeFrame: baseline, weeks 6, 12, and 24
measure: Change of Cardiovascular Systems - FEV1
timeFrame: baseline, weeks 6, 12, and 24
measure: Change of Cardiovascular Systems - FCV
timeFrame: baseline, weeks 6, 12, and 24
measure: Change of Fatigue
timeFrame: baseline, weeks 6, 12, and 24
measure: Change of Neuropathy 15-17 year olds
timeFrame: baseline, weeks 6, 12, and 24
measure: Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FEV1
timeFrame: baseline, weeks 6, 12, and 24
measure: Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FVC
timeFrame: baseline, weeks 6, 12, and 24
measure: Change of Cancer Therapy Fatigue
timeFrame: baseline, weeks 6, 12, and 24
measure: Change of Neuropathy over 17 years of age
timeFrame: baseline, weeks 6, 12, and 24
Secondary outcomes:
measure: Depression - BDI
timeFrame: Baseline, weeks 12 and 24.
measure: Depression - CDI
timeFrame: Baseline, weeks 12 and 24.
measure: Beck Anxiety Inventory
timeFrame: Baseline, weeks 12 and 24.
measure: Measure health-related Quality of Life
timeFrame: Baseline, weeks 12 and 24.
measure: Healthy Days Core Module (CDC HRQOL-4
timeFrame: baseline, weeks 6, 12, and 24
measure: Pain scale
timeFrame: baseline, weeks 6, 12, and 24
measure: Pittsburgh Sleep Quality Index Survey
timeFrame: baseline, weeks 6, 12, and 24
measure: Adverse Event Pain Assessment
timeFrame: baseline, weeks 6, 12, and 24
Other outcomes:
Locations:
city: Carmel
country: United States
facility: IU Health North Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Riley Hospital for Children - Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Healthplex
state: Indiana
Study officials:
References: