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

February 6, 2024 updated by: Pooja Rao, Milton S. Hershey Medical Center

AYA-UNITE (Utilizing Novel Information Technology to Promote Exercise and Well-Being)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adolescents and young adults (AYAs) with cancer comprise a unique population within the larger cancer community. This is primarily due to distinct differences in disease biology compared to older and younger patients, as well as their unique psychosocial needs. AYAs with cancer historically have unmet needs relating to management of their mental health and treatment-related symptoms. One particular area of unmet need is distress management during cancer treatment, reported in nearly one third of AYAs with newly diagnosed cancer. Reasons for distress are multifactorial, including lack of medical information, worries about future life goals and fertility, and social isolation from peers and family. Proactively addressing and preventing this distress is critical for forestalling the high rates of depression, anxiety, and post-traumatic stress seen in AYAs. One promising but under explored intervention with the potential to mitigate distress is group-based physical activity. Multiple studies cite physical activity's benefits for patients with cancer, while oncology and sports medicine societies recommend including physical activity as part of comprehensive cancer care. Group physical activity intervention models have been successful in creating sustainable improvements in physical and psychosocial health in other populations with cancer, though can present transportation and scheduling barriers. Additionally, medical providers and participants undergoing treatment for cancer may be hesitant to engage in group-based physical activity interventions during times of neutropenia given infection risk.

Dr. Rao's mentors have extensive preliminary data that guided her project's development. The theoretical model for this study's intervention delivery is based on Dr. Rovniak's Social Networks for Activity Promotion (SNAP) model, and targets optimizing the physical environment where physical activity is received, as well as the importance of social network environments and interactions. Dr. Schmitz has been at the forefront of the movement to incorporate physical activity into the care of patients with cancer and cancer survivors. She has led multiple trials, including a large randomized controlled trial to assess the safety of upper body exercise among breast cancer survivors with and without lymphedema (Physical Activity and Lymphedema Trial [PAL]). Dr. Sciamanna's work has evaluated the implementation of a group strength training intervention in elderly patients, which has been found to be safe and effective, as well socially beneficial to its participants. Dr. Williams is the founder and president of Hip Hop for Public Health (HHPH) a non-profit organization which has successfully utilized hip-hop music to deliver sustainable health messages pertaining to nutrition and physical activity in youth.

The preliminary data as noted above set the foundation for this project, which builds on the importance of social network environments and interactions in encouraging physical activity. This is particularly true for adolescents as a whole, as social support has been found to be an especially important factor in the promotion of physical activity. Specifically for AYAs with cancer, physical activity has been cited as an area of preferred clinical program focus for AYAs with cancer and those who have completed treatment. Thus, a group-based physical activity intervention among AYAs with cancer could address an area of unmet need that potentially improves the psychosocial health of this patient population. Delivery using a virtual platform is culturally appropriate for AYAs with cancer, a unique patient population that is technologically savvy, and interested in using social media platforms to create a sense of belonging and community.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Active bleeding
  • Absolute contraindication to exercise
  • Hemodynamic instability
  • Pregnant women
  • Non-English speaking
  • Recent initiation of physical activity program within last 3 months
  • Patients with relapsed cancer
  • Patients who have undergone allogeneic stem cell transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Outpatient Physical Activity Program
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
Participants will engage in a multimodal aerobic and strength training intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Weekly during 12 week study
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
Time Frame: At end of 12 week study
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
Time Frame: At end of 12 week study
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical function assessments: Arm curl test of dominant arm (tests upper body strength)
Time Frame: Baseline and at end of 12 week study
Arm curl test assessment will be performed on all participants using free weights of 5 lb and 8 lb (or household alternative object)
Baseline and at end of 12 week study
Physical function assessments: 30-second Chair Stand (tests leg strength and endurance)
Time Frame: Baseline and at end of 12 week study
The 30-second Chair Stand will be performed on all participants
Baseline and at end of 12 week study
Physical function assessments: Timed Up and Go (tests mobility)
Time Frame: Baseline and at end of 12 week study
The Timed Up and Go test will be performed on all participants
Baseline and at end of 12 week study
Physical function assessments: 4-Stage Balance (tests balance)
Time Frame: Baseline and at end of 12 week study
The 4-Stage Balance will be performed on all participants
Baseline and at end of 12 week study
Physical function assessments: Patient reported physical function
Time Frame: Baseline and at end of 12 week study
Physical function: The Patient-Reported Outcomes Measurement Information System (PROMIS)
Baseline and at end of 12 week study
Psychosocial measurements: Distress
Time Frame: Baseline and at end of 12 week study
Distress: The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Psychological Stress Experiences Form will be used.
Baseline and at end of 12 week study
Psychosocial measurements: Social Isolation
Time Frame: Baseline and at end of 12 week study
Social Isolation: The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank Social Isolation Short Form 8a will be used.
Baseline and at end of 12 week study
Psychosocial measurements: Fatigue
Time Frame: Baseline and at end of 12 week study
Fatigue: The Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Item Bank v1.0- Fatigue will be used.
Baseline and at end of 12 week study
Psychosocial measurements: Quality of Life
Time Frame: Baseline and at end of 12 week study
Quality of Life: The Patient-Reported Outcomes Measurement Information System (PROMIS) PROMIS-29 Profile will be used.
Baseline and at end of 12 week study
Patient-reported symptoms
Time Frame: All participants will be given this instrument once prior to study initiation, and once every 3 weeks during the study.
PRO-CTCAE will be used to collect and measure information of patient-PRO-CTCAE will be used to collect and measure information of patient-reported symptoms.
All participants will be given this instrument once prior to study initiation, and once every 3 weeks during the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Pooja Rao, MD MSCE, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00010118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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