Exercise Intervention in Adolescent and Young Adult Cancer Survivors

• ClinicalTrials.gov Identifier: NCT04265638
• Recruitment Status: Recruiting
• First Posted: February 11, 2020
• Last Update Posted: February 17, 2020
• Sponsor: Indiana University
• Information provided by (Responsible Party): Jamie Renbarger, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Long-term Effects Secondary to Cancer Therapy in Adults; Pediatric Cancer	Behavioral: Exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: One-on-one Exercise Program in Adolescent and Young Adult Cancer Survivors With a Certified Clinical Cancer Exercise Specialist
• Actual Study Start Date: June 5, 2019
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: April 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exercise	Behavioral: Exercise; One on one exercise with a cancer exercise specialist 1 hour 3 times a week for 12 weeks.
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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

5. 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

6. 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.
7. 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.
8. 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

9. 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

10. 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.
11. 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 Outcome Measures :

1. Depression - BDI [ Time Frame: Baseline, weeks 12 and 24. ]
   Beck Depression Inventory (BDI): The BDI is a 21-item self-report rating inventory for characteristics of depression with ratings from 0 to 3, with 3 being the most intense. The BDI is for individuals 19 and older.
2. Depression - CDI [ Time Frame: Baseline, weeks 12 and 24. ]
   Title: Children's Depression Inventory (CDI): The CDI is a 27-item scale that is self-rated and symptom-oriented. It is a validated test for children 18 and under. There are 27 items with scores ranging from 0-2, so there is a possible total score of 0-54, with 0 being no depression to 54 being the worst. The non-clinical cut off score is 19-20, which will be the one we are using.
3. Beck Anxiety Inventory [ Time Frame: Baseline, weeks 12 and 24. ]

   The BAI is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs[4] are:

   0-7: minimal anxiety 8-15: mild anxiety 16-25: moderate anxiety 26-63: severe anxiety

4. Measure health-related Quality of Life [ Time Frame: Baseline, weeks 12 and 24. ]
   Pediatric Quality of Life Inventory (PedsQL 4.0): The PedsQL is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL integrates generic core scales and disease-specific modules into one measurement system. The 23-item PedsQL generic core scales and disease-specific scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. This measure is tailored to 5 different age groups: however, we will only use the section designed for teens (13-18) which is made up of 23 items comprising 4 dimensions. Ferrans & Powers Quality of Life Index: Total quality of life will be measured using the Ferrans and Powers Quality of Life Index Version III and is a 66-question index designed to evaluate social, psychological, family, and health satisfaction. This assessment is valid for ages 18 and up.
5. Healthy Days Core Module (CDC HRQOL-4 [ Time Frame: baseline, weeks 6, 12, and 24 ]
   The HRQOL is a 4-question assessment of overall health, both physical and mental health. The questionnaire is scored as follows: First unhealthy days are calculated as an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. The score for obtaining unhealthy days is done by combining the responses to questions 2 and 3 to calculate a summary index of overall unhealthy days, with a logical maximum of 30 unhealthy days.
6. Pain scale [ Time Frame: baseline, weeks 6, 12, and 24 ]
   Visual Analogue Scale (VAS): The VAS is a validated pain measurement for individuals age seven and older. The scale is a single line with one end denoting no pain and the other, the worst pain possible. The scale was validated in 1976 with a reliability score of 0.94. The VAS is a scale of 100-mm and ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain81
7. Pittsburgh Sleep Quality Index Survey [ Time Frame: baseline, weeks 6, 12, and 24 ]
   The PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The 19 ques-tions are combined into 7 clinically-derived component scores, each weighted equally from 0-3. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
8. Adverse Event Pain Assessment [ Time Frame: baseline, weeks 6, 12, and 24 ]
   The NCI Common Terminology Criteria for Adverse Events (CTCAE) V4.02: The NCI Common Terminology Criteria for Adverse Events Version 4.02 is a descriptive scale that grades adverse events occurring after chemotherapy in cancer patients and explores the quality of life (QOL) findings among post therapy cancer patients. A grading (severity) scale is provided for each AE term. The grading scale is 0-5 with Grade 0: no signs or symptoms of the Adverse Event to Grade 5: death.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 39 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Jamie Renbarger, MD; 317-944-8784; jarenbar@iu.edu

Locations

United States, Indiana

IU Health North Hospital; Recruiting

Carmel, Indiana, United States, 46032

Contact: Jamie Renbarger, MD 317-944-8784 jarenbar@iu.edu

Riley Hospital for Children - Indiana University; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Jamie Renbarger, MD 317-944-8784 jarenbar@iu.edu

Indianapolis Healthplex; Recruiting

Indianapolis, Indiana, United States, 46222

Contact: Adnan Hyder 317-920-7400 ahyder@indianapolishealthplex.com

Sponsors and Collaborators

Indiana University

More Information

• Responsible Party: Jamie Renbarger, Associate Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT04265638
• Other Study ID Numbers: IUSCC-0696
• First Posted: February 11, 2020
• Last Update Posted: February 17, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No