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Exercise Intervention in Adolescent and Young Adult Cancer Survivors

NCT ID: NCT04265638

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-05

Study Completion Date

2024-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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NiCole Keith

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IU Health North Hospital

Carmel, Indiana, United States

Site Status RECRUITING

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, United States

Site Status RECRUITING

Indianapolis Healthplex

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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NiCole Keith, PhD

Role: CONTACT

[email protected]
317-278-8438

Facility Contacts

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NiCole Keith, PhD

Role: primary

[email protected]
317-278-8438

NiCole Keith, PhD

Role: primary

[email protected]
317-278-8438

Adnan Hyder

Role: primary

[email protected]
317-920-7400

References

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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.

Reference Type DERIVED
PMID: 39606939 (View on PubMed)

Other Identifiers

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IUSCC-0696

Identifier Type: -

Identifier Source: org_study_id