One-on-one Exercise Program in Adolescent and Young Adult Cancer Survivors With a Certified Clinical Cancer Exercise Specialist
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Long-term Effects Secondary to Cancer Therapy in Adults
- Sponsor
- Indiana University
- Enrollment
- 66
- Locations
- 3
- Primary Endpoint
- Change of Balance Assessment
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
NiCole Keith
Professor
Indiana University
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 15 and ≤ 39 years,
- •History of cancer
- •At least three months off of cytotoxic chemotherapy (note: hormone therapy is permitted)
Exclusion Criteria
- •Evidence of significant liver dysfunction, congestive heart failure, cardiovascular disease
- •History of CNS tumor
- •Down's Syndrome
- •Unable to perform aerobic and/or strength exercises with full range of motion (limb immobilization, limb amputation, or surgical complications.
- •Neurological disorder
- •Baseline exercise of 30 minutes per day three times a week already being performed.
Outcomes
Primary Outcomes
Change of Balance Assessment
Time Frame: baseline, weeks 6, 12, and 24
The BOT2 Balance subtests 5, Number 2: Walking forward on a line and Subtest 5, Number 7: Standing on One leg on a balance beam - Eyes Open will evaluate motor-control skills that are integral for maintaining posture when standing, walking, or reaching. This motor-area composite measures control and coordination of the large musculature that aids in posture and balance. Scores are assessed to determine stability dynamically and statically, on one leg and utilizing both legs, on a balance beam when the eyes are open for more than 10 seconds and if the patient can likely do so when the eyes are closed for about 5 to 10 seconds and also a twenty-four foot straight line.
Change of Cardiovascular Systems - FEV1
Time Frame: baseline, weeks 6, 12, and 24
The subject's forced expiratory volume in one second (FEV1) will be used to assess the cardiovascular system. FEV1: Male = \[0.0566 (ht in cm)\] - \[0.0233 (age)\] - 4.91
Change of Cardiovascular Systems - VO2 Peak (mL·kg-1·min-1)
Time Frame: baseline, weeks 6, 12, and 24
The subject's VO2 Peak (mL-kg-1-min-1) will be used to assess the cardiovascular system.
Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FEV1
Time Frame: baseline, weeks 6, 12, and 24
The subject's VO2 Peak (mL-kg-1-min-1) will be used to forced expiratory volume in one second (FEV1). FEV1: Male = \[0.0566 (ht in cm)\] - \[0.0233 (age)\] - 4.91
Change of the Participant Evaluation of Feasibility and Acceptability Questionnaire
Time Frame: weeks 12 and 24
The Participant Evaluation of Feasibility and Acceptability Questionnaire consists of 6 items arranged on a Likert scale ranging from 1- 5, and 4 additional open-ended questions designed to elicit information concerning the benefits and barriers to participating in the resistance exercise intervention.
Change of Cardiovascular Systems - FCV
Time Frame: baseline, weeks 6, 12, and 24
The subject's estimated forced vital capacity (FVC) will be used to assess the cardiovascular system. FVC: Male = \[0.0774 (ht in cm)\] - \[0.0212 (age)\] - 7.75 Female = \[0.0414 (ht in cm)\] - \[0.0232 (age)\] - 2.2
Change of Cancer Therapy Fatigue
Time Frame: baseline, weeks 6, 12, and 24
Functional Assessment of Cancer Therapy Fatigue Scale (FACIT-F) Brief: A questionnaire assessing fatigue and anemia-related concerns in people with cancer.
Change of Fatigue
Time Frame: baseline, weeks 6, 12, and 24
The Revised Piper Fatigue Scale: Fatigue will be measured using the Piper Fatigue Inventory, which evaluates total cancer-related fatigue, as well as subscales of fatigue such as affective, behavior, cognitive, mood, and sensory. There are 4 individual subscales comprise 22 items with the average score representing total fatigue. The subscales are behavioral/severity (6 items), affective meaning (5 items), sensory (5 items) and cognitive/mood (6 items). Standardized alpha for the entire scale (n = 22 items) is 0.97, indicating that some redundancy still may exist among the items. The scale ranges from 0 to 10. A score of 0 indicates that the participant shows no signs of fatigue; a score from 1 to 3 indicates mild fatigue, 4-6 indicates moderate fatigue and a score greater than 7 indicates severe fatigue.
Change of Neuropathy 15-17 year olds
Time Frame: baseline, weeks 6, 12, and 24
Pediatric Total Neuropathy Score (Peds-TNS): A multidimensional instrumentused to measure peripheral neuropathy symptoms and signs in children from 15-17 years old. This instrument assesses proximal extension of numbness, tingling, and neuropathic pain, motor function, vibration and touch sensation, strength, tendon reflexes, dizziness. These parameters provide qualitative information on symptoms, nerve conduction and sensory tests on a scale of 0 for none to 4 for severe. The individual scores are added together to provide a single measure of neuropathy called a Total Neuropathy Score.
Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FVC
Time Frame: baseline, weeks 6, 12, and 24
The subject's VO2 Peak (mL-kg-1-min-1) will be used to forced expiratory volume in estimated forced vital capacity (FVC). FVC: Male = \[0.0774 (ht in cm)\] - \[0.0212 (age)\] - 7.75 Female = \[0.0414 (ht in cm)\] - \[0.0232 (age)\] - 2.2
Change of Neuropathy over 17 years of age
Time Frame: baseline, weeks 6, 12, and 24
Total Neuropathy Score Clinical Evaluation (TNS): The best acknowledged method to assess the severity and changes in chemotherapy-induced peripheral neurotoxicity for individuals over 17. The TNSc consists of items with scores correlating significantly with the National Cancer Institute-Common Toxicity Criteria v. 2.0
Secondary Outcomes
- Depression - BDI(Baseline, weeks 12 and 24.)
- Depression - CDI(Baseline, weeks 12 and 24.)
- Pain scale(baseline, weeks 6, 12, and 24)
- Pittsburgh Sleep Quality Index Survey(baseline, weeks 6, 12, and 24)
- Adverse Event Pain Assessment(baseline, weeks 6, 12, and 24)
- Beck Anxiety Inventory(Baseline, weeks 12 and 24.)
- Measure health-related Quality of Life(Baseline, weeks 12 and 24.)
- Healthy Days Core Module (CDC HRQOL-4(baseline, weeks 6, 12, and 24)