Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03778658
Recruitment Status : Not yet recruiting
First Posted : December 19, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Pooja Rao, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Adolescent Young Adult Cancer Physical Activity Psychological Distress Social Isolation Behavioral: Physical Activity Intervention Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: AYA-UNITE (Utilizing Novel Information Technology to Promote Exercise and Well-Being)
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Safety (proportions 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) [ Time Frame: End of Week 1-12 ]
    Safety as defined in Title will be measured by participants in both study arms

  2. Feasibility of intervention, defined as at least 50% of participants in physical activity intervention arm who complete 80% of the training sessions. [ 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.

  3. Acceptability of intervention, defined as more than 50% of approached participants agreeing to receive at least the first session of the physical activity intervention. [ Time Frame: Acceptability will be measured at the end of Week 1 of study in intervention arm ]
    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.


Secondary Outcome Measures :
  1. Physical function assessments- Grip Strength Dynamometer (tests maximum isometric hand and forearm strength) [ Time Frame: Baseline and at end of 12 week study ]
    Grip Strength Dynamometer assessments will be performed on all participants

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 smart phone
  • Performance status of Eastern Cooperative Oncology Group (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
  • Acute pulmonary embolus or pulmonary infarction
  • Thrombosis of lower extremities
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778658


Contacts
Layout table for location contacts
Contact: Erica A Schleicher, MS 717-531-0003 ext 323324 eschleicher1@phs.psu.edu

Locations
Layout table for location information
United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Pooja Rao, MD MSCE Milton S. Hershey Medical Center

Publications:

Layout table for additonal information
Responsible Party: Pooja Rao, Pooja Rao, M.D. , Assistant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03778658    
Other Study ID Numbers: STUDY00010118
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pooja Rao, Milton S. Hershey Medical Center:
Adolescent/Young Adult
Cancer
Physical Activity
Psychosocial Health