Clinical trial NCT03778658: Utilizing Novel Information Technology to Promote Exercise and Well-Being in Adolescents and Young Adults With Cancer
Official title: AYA-UNITE (Utilizing Novel Information Technology to Promote Exercise and Well-Being)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent
Young Adult
Cancer
Physical Activity
Psychological Distress
Social Isolation
Keywords: Adolescent/Young Adult
Cancer
Physical Activity
Psychosocial Health
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 7
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: Weekly during 12 week study
measure: Feasibility
timeFrame: At end of 12 week study
measure: Acceptability
timeFrame: At end of 12 week study
Secondary outcomes:
measure: Physical function assessments: Arm curl test of dominant arm (tests upper body strength)
timeFrame: Baseline and at end of 12 week study
measure: Physical function assessments: 30-second Chair Stand (tests leg strength and endurance)
timeFrame: Baseline and at end of 12 week study
measure: Physical function assessments: Timed Up and Go (tests mobility)
timeFrame: Baseline and at end of 12 week study
measure: Physical function assessments: 4-Stage Balance (tests balance)
timeFrame: Baseline and at end of 12 week study
measure: Physical function assessments: Patient reported physical function
timeFrame: Baseline and at end of 12 week study
measure: Psychosocial measurements: Distress
timeFrame: Baseline and at end of 12 week study
measure: Psychosocial measurements: Social Isolation
timeFrame: Baseline and at end of 12 week study
measure: Psychosocial measurements: Fatigue
timeFrame: Baseline and at end of 12 week study
measure: Psychosocial measurements: Quality of Life
timeFrame: Baseline and at end of 12 week study
measure: Patient-reported symptoms
timeFrame: All participants will be given this instrument once prior to study initiation, and once every 3 weeks during the study.
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Pooja Rao, MD MSCE
role: PRINCIPAL_INVESTIGATOR
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