Utilizing Novel Information Technology to Promote Exercise and Well-Being in Adolescents and Young Adults With Cancer

NCT03778658 | Completed

• 1 other identifier: STUDY00010118
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescents and young adults (AYAs) with cancer have many needs for supportive care that differ from younger and older patients.This includes age-appropriate psychological support for management of distress, as well as supports for the social isolation many AYAs experience. One intervention that may provide AYAs with cancer improved psychosocial support, as well as increased physical strength, is physical activity. This feasibility project aims to evaluate the safety, feasibility and acceptability of a physical activity training in AYAs with cancer delivered via a socially interactive videoconferencing platform.

Conditions

Adolescent; Young Adult; Cancer; Physical Activity; Psychological Distress; Social Isolation

Keywords

Adolescent/Young Adult; Cancer; Physical Activity; Psychosocial Health

Outcome Measures

Primary Outcomes (3)

• Safety

  Proportion of participants experiencing musculoskeletal (MSK) impairment, adverse effects requiring treatment alterations, and injury rate for MSK injuries (defined as symptoms lasting 1 week or longer and/or requiring attention of provider)

  Weekly during 12 week study

• Feasibility

  Physical activity intervention arm will be considered feasible if at least 50% of the participants complete 80% of the training sessions.

  At end of 12 week study

• Acceptability

  The physical activity intervention will be considered acceptable if more than 50% of the approached participants agree to receive at least the first session of the physical activity intervention.

  At end of 12 week study

Secondary Outcomes (10)

• Physical function assessments: Arm curl test of dominant arm (tests upper body strength)

  Baseline and at end of 12 week study

• Physical function assessments: 30-second Chair Stand (tests leg strength and endurance)

  Baseline and at end of 12 week study

• Physical function assessments: Timed Up and Go (tests mobility)

  Baseline and at end of 12 week study

• Physical function assessments: 4-Stage Balance (tests balance)

  Baseline and at end of 12 week study

• Physical function assessments: Patient reported physical function

  Baseline and at end of 12 week study

Study Arms (1)

Outpatient Physical Activity Program

EXPERIMENTAL

The intervention will investigate a multi modal outpatient physical activity program incorporating both strength training utilizing resistance bands, as well as an aerobic activity based on hip-hop dancing.

Behavioral: Physical Activity Intervention

Interventions

Physical Activity Intervention BEHAVIORAL

Participants will engage in a multimodal aerobic and strength training intervention.

Outpatient Physical Activity Program

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant age 15-21 years old at time of cancer diagnosis
• Participant diagnosis of cancer who is currently undergoing active treatment for cancer, or who is within 3 years of end of cancer treatment at the time of enrollment
• Participant receiving oncologic care at Penn State Health Children's Hospital or Penn State Cancer Institute
• Participant fluency in written and spoken English for participants \>= 18 years old
• Parent and participant fluency in written and spoken English for participants \< 18 years old
• Primary attending oncologist approval
• Participant must have access to a computer or smartphone
• Performance status of ECOG \<= 2, and Lansky /Karnofsky scale \>= 50

You may not qualify if:

• Cardiovascular or respiratory disease
• Class II, III or IV heart failure as defined by the New York Heart Association functional classification system
• History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of chemotherapy
• Uncontrolled arrhythmias
• Syncope
• Acute myocarditis, pericarditis or endocarditis
• Diagnosed with pulmonary embolism or pulmonary infarction within 3 months of enrollment
• Diagnosed with deep venous thrombosis within 3 months of enrollment
• Any history of intracardiac thrombosis
• Suspected dissecting aneurysm
• Pulmonary edema
• Respiratory failure
• Acute non-cardiopulmonary disorder that may affect exercise performance or be exacerbated by physical activity
• Altered mental status or dementia
• Mental impairment leading to inability to cooperate

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

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MeSH Terms

Conditions

Neoplasms; Motor Activity; Social Isolation

Condition Hierarchy (Ancestors)

Behavior; Social Behavior

Study Officials

• Pooja Rao, MD MSCE

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pooja Rao, M.D. , Assistant Professor

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 19, 2018
• Study Start: December 15, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)