AzTrials
AzTrials

AdolescentAYA-UNITENCT03778658

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

A study testing Physical Activity Intervention in people with Adolescent and Young Adult, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Adolescent, Young Adult, Cancer
What is being tested?
Physical Activity Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
15 Dec 2020to 1 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Physical Activity Intervention
Keywords
Adolescent/Young Adult, Cancer, Physical Activity, Psychosocial Health
Medical subject headings
Neoplasms, Motor Activity, Social Isolation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity InterventionBehavioural

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

Study groups in NCT03778658
Study groupRoleWhat they receive
Outpatient Physical Activity ProgramExperimentalThe 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.
Receives: Behavioral: Physical Activity Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Weekly during 12 week study

  2. Feasibility

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

    Measured: At end of 12 week study

  3. 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.

    Measured: At end of 12 week study

Secondary outcomes (10)

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

    Arm curl test assessment will be performed on all participants using free weights of 5 lb and 8 lb (or household alternative object)

    Measured: Baseline and at end of 12 week study

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

    The 30-second Chair Stand will be performed on all participants

    Measured: Baseline and at end of 12 week study

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

    The Timed Up and Go test will be performed on all participants

    Measured: Baseline and at end of 12 week study

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

    The 4-Stage Balance will be performed on all participants

    Measured: Baseline and at end of 12 week study

  5. Physical function assessments: Patient reported physical function

    Physical function: The Patient-Reported Outcomes Measurement Information System (PROMIS)

    Measured: Baseline and at end of 12 week study

  6. Psychosocial measurements: Distress

    Distress: The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Psychological Stress Experiences Form will be used.

    Measured: Baseline and at end of 12 week study

  7. Psychosocial measurements: Social Isolation

    Social Isolation: The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank Social Isolation Short Form 8a will be used.

    Measured: Baseline and at end of 12 week study

  8. Psychosocial measurements: Fatigue

    Fatigue: The Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Item Bank v1.0- Fatigue will be used.

    Measured: Baseline and at end of 12 week study

  9. Psychosocial measurements: Quality of Life

    Quality of Life: The Patient-Reported Outcomes Measurement Information System (PROMIS) PROMIS-29 Profile will be used.

    Measured: Baseline and at end of 12 week study

  10. Patient-reported symptoms

    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.

    Measured: All participants will be given this instrument once prior to study initiation, and once every 3 weeks during the study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start15 Dec 2020
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03778658
Sponsor's protocol ID
STUDY00010118
Acronym
AYA-UNITE
Status last verified
Feb 2024
First submitted
13 Dec 2018
Last updated
8 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schmitz KH, Ahmed RL, Troxel A, Cheville A, Smith R, Lewis-Grant L, Bryan CJ, Williams-Smith CT, Greene QP. Weight lifting in women with breast-cancer-related lymphedema. N Engl J Med. 2009 Aug 13;361(7):664-73. doi: 10.1056/NEJMoa0810118.

    PubMed 19675330

  • Powell KE, Heath GW, Kresnow MJ, Sacks JJ, Branche CM. Injury rates from walking, gardening, weightlifting, outdoor bicycling, and aerobics. Med Sci Sports Exerc. 1998 Aug;30(8):1246-9. doi: 10.1097/00005768-199808000-00010.

    PubMed 9710864

  • Courneya KS, McKenzie DC, Reid RD, Mackey JR, Gelmon K, Friedenreich CM, Ladha AB, Proulx C, Lane K, Vallance JK, Segal RJ. Barriers to supervised exercise training in a randomized controlled trial of breast cancer patients receiving chemotherapy. Ann Behav Med. 2008 Feb;35(1):116-22. doi: 10.1007/s12160-007-9009-4. Epub 2008 Feb 20.

    PubMed 18347912

  • Zhang X, McClean D, Ko E, Morgan MA, Schmitz K. Exercise Among Women With Ovarian Cancer: A Feasibility and Pre-/Post-Test Exploratory Pilot Study. Oncol Nurs Forum. 2017 May 1;44(3):366-374. doi: 10.1188/17.ONF.366-374.

    PubMed 28635971

  • Hinds PS, Nuss SL, Ruccione KS, Withycombe JS, Jacobs S, DeLuca H, Faulkner C, Liu Y, Cheng YI, Gross HE, Wang J, DeWalt DA. PROMIS pediatric measures in pediatric oncology: valid and clinically feasible indicators of patient-reported outcomes. Pediatr Blood Cancer. 2013 Mar;60(3):402-8. doi: 10.1002/pbc.24233. Epub 2012 Jul 24.

    PubMed 22829446

  • Henderson JR 2nd, Kiernan E, McNeer JL, Rodday AM, Spencer K, Henderson TO, Parsons SK. Patient-Reported Health-Related Quality-of-Life Assessment at the Point-of-Care with Adolescents and Young Adults with Cancer. J Adolesc Young Adult Oncol. 2018 Feb;7(1):97-102. doi: 10.1089/jayao.2017.0046. Epub 2017 Nov 30.

    PubMed 29190179

  • Warner EL, Kent EE, Trevino KM, Parsons HM, Zebrack BJ, Kirchhoff AC. Social well-being among adolescents and young adults with cancer: A systematic review. Cancer. 2016 Apr 1;122(7):1029-37. doi: 10.1002/cncr.29866. Epub 2016 Feb 5.

    PubMed 26848713

  • Barakat LP, Galtieri LR, Szalda D, Schwartz LA. Assessing the psychosocial needs and program preferences of adolescents and young adults with cancer. Support Care Cancer. 2016 Feb;24(2):823-832. doi: 10.1007/s00520-015-2849-8. Epub 2015 Jul 21.

    PubMed 26190361

  • Muffly LS, Hlubocky FJ, Khan N, Wroblewski K, Breitenbach K, Gomez J, McNeer JL, Stock W, Daugherty CK. Psychological morbidities in adolescent and young adult blood cancer patients during curative-intent therapy and early survivorship. Cancer. 2016 Mar 15;122(6):954-61. doi: 10.1002/cncr.29868. Epub 2016 Jan 7.

    PubMed 26749023

  • Quinn GP, Goncalves V, Sehovic I, Bowman ML, Reed DR. Quality of life in adolescent and young adult cancer patients: a systematic review of the literature. Patient Relat Outcome Meas. 2015 Feb 17;6:19-51. doi: 10.2147/PROM.S51658. eCollection 2015.

    PubMed 25733941

  • Burgoyne MJ, Bingen K, Leuck J, Dasgupta M, Ryan P, Hoffmann RG. Cancer-Related Distress in Young Adults Compared to Middle-Aged and Senior Adults. J Adolesc Young Adult Oncol. 2015 Jun;4(2):56-63. doi: 10.1089/jayao.2014.0005. Epub 2015 Jun 2.

    PubMed 26812552

  • McCarthy MC, McNeil R, Drew S, Orme L, Sawyer SM. Information needs of adolescent and young adult cancer patients and their parent-carers. Support Care Cancer. 2018 May;26(5):1655-1664. doi: 10.1007/s00520-017-3984-1. Epub 2017 Dec 8.

    PubMed 29222598

  • McCarthy MC, McNeil R, Drew S, Dunt D, Kosola S, Orme L, Sawyer SM. Psychological Distress and Posttraumatic Stress Symptoms in Adolescents and Young Adults with Cancer and Their Parents. J Adolesc Young Adult Oncol. 2016 Dec;5(4):322-329. doi: 10.1089/jayao.2016.0015. Epub 2016 May 23.

    PubMed 27214245

  • Kwak M, Zebrack BJ, Meeske KA, Embry L, Aguilar C, Block R, Hayes-Lattin B, Li Y, Butler M, Cole S. Trajectories of psychological distress in adolescent and young adult patients with cancer: a 1-year longitudinal study. J Clin Oncol. 2013 Jun 10;31(17):2160-6. doi: 10.1200/JCO.2012.45.9222. Epub 2013 May 6.

    PubMed 23650425

  • Kwak M, Zebrack BJ, Meeske KA, Embry L, Aguilar C, Block R, Hayes-Lattin B, Li Y, Butler M, Cole S. Prevalence and predictors of post-traumatic stress symptoms in adolescent and young adult cancer survivors: a 1-year follow-up study. Psychooncology. 2013 Aug;22(8):1798-806. doi: 10.1002/pon.3217. Epub 2012 Nov 8.

    PubMed 23135830

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Intervention in people with Adolescent and Young Adult, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: Weekly during 12 week study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03778658, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in