Exercise Intervention in Adolescent and Young Adult Cancer Survivors

NCT04265638 | Unknown DMC

• 1 other identifier: IUSCC-0696
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

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.

Conditions

Long-term Effects Secondary to Cancer Therapy in Adults; Pediatric Cancer

Outcome Measures

Primary Outcomes (11)

• Change of the Participant Evaluation of Feasibility and Acceptability Questionnaire

  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.

  weeks 12 and 24

• Change of Balance Assessment

  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.

  baseline, weeks 6, 12, and 24

• Change of Cardiovascular Systems - VO2 Peak (mL·kg-1·min-1)

  The subject's VO2 Peak (mL-kg-1-min-1) will be used to assess the cardiovascular system.

  baseline, weeks 6, 12, and 24

• Change of Cardiovascular Systems - FEV1

  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

  baseline, weeks 6, 12, and 24

• Change of Cardiovascular Systems - FCV

  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

  baseline, weeks 6, 12, and 24

• Change of Fatigue

  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.

  baseline, weeks 6, 12, and 24

• Change of Neuropathy 15-17 year olds

  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.

  baseline, weeks 6, 12, and 24

• Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FEV1

  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

  baseline, weeks 6, 12, and 24

• Change of Pulmonary Systems - VO2 Peak (mL·kg-1·min-1) - FVC

  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

  baseline, weeks 6, 12, and 24

• Change of Cancer Therapy Fatigue

  Functional Assessment of Cancer Therapy Fatigue Scale (FACIT-F) Brief: A questionnaire assessing fatigue and anemia-related concerns in people with cancer.

  baseline, weeks 6, 12, and 24

• Change of Neuropathy over 17 years of age

  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

  baseline, weeks 6, 12, and 24

Secondary Outcomes (8)

• Depression - BDI

  Baseline, weeks 12 and 24.

• Depression - CDI

  Baseline, weeks 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

Study Arms (2)

Exercise

EXPERIMENTAL

Behavioral: Exercise

Usual Care

NO INTERVENTION

Interventions

Exercise BEHAVIORAL

One on one exercise with a cancer exercise specialist 1 hour 3 times a week for 12 weeks.

Exercise

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (3)

IU Health North Hospital

Carmel, Indiana, 46032, United States

RECRUITING

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Indianapolis Healthplex

Indianapolis, Indiana, 46222, United States

RECRUITING

Related Publications (1)

• Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

  PMID: 39606939 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

NiCole Keith, PhD

CONTACT

317-278-8438; nkeith@iupui.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: February 11, 2020
• Study Start: June 5, 2019
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)