Clinical trial · Interventional
Utilizing Novel Information Technology to Promote Exercise and Well-Being in Adolescents and Young Adults With Cancer
AYA-UNITE (Utilizing Novel Information Technology to Promote Exercise and Well-Being)
NCT03778658CI-TRIAL-00073850AYA-UNITEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adolescent | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Physical Activity | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
| Social Isolation | — | UNRESOLVED | — |
| Young Adult | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Activity Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Outpatient Physical Activity Program
- description
- 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.
- interventionNames
- Behavioral: Physical Activity Intervention
Primary outcomes (3)
- measure
- Safety
- timeFrame
- Weekly during 12 week study
- description
- 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)
- measure
- Feasibility
- timeFrame
- At end of 12 week study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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
References
Publications (34)
- BACKGROUNDSchmitz 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. PMID 19675330
- BACKGROUNDPowell 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. PMID 9710864
- BACKGROUNDCourneya 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. PMID 18347912
- BACKGROUNDZhang 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. PMID 28635971
- BACKGROUNDHinds 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. PMID 22829446
- BACKGROUNDHenderson 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. PMID 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.