Clinical trial · Observational
Adolescent and Young Adult Cancer Patients: Cognitive Toxicity on Survivorship (ACTS)
NCT03476070CI-TRIAL-00053709unknownClinicalTrials.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)
This study aims to evaluate the prevalence, biological mechanism and survivorship impact of cognitive toxicity among adolescent and young adult (AYA) patients diagnosed with curable cancers. The hypothesis is that cognitive impairment is clinically significant among AYA cancer patients treated with chemotherapy and that there will be detectable structural and functional changes in the brain for this patient group.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive Impairment | — | UNRESOLVED | — |
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- AYA cancer patients
- description
- Patients (aged between 15-39) diagnosed with breast cancer, lymphoma or germ cell tumor
- label
- Healthy controls
- description
- Healthy controls
Primary outcomes (1)
- measure
- Prevalence of cognitive impairment in AYA cancer patients
- timeFrame
- 6 months post recruitment
- description
- Compare the prevalence of overall cognitive impairment at 6 months from baseline, between AYA cancer patients and healthy controls. Cognitive impairment is measured by the overall cognitive performance using the objective computer-based Cambridge Neuropsychological Test Automated Battery (Cantab ®).
Secondary outcomes (9)
- measure
- Prevalence of impairment in each individual Cantab ® cognitive domain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: * between 15-39 years of age * newly diagnosed with breast cancer, lymphoma or germ cell tumor with treatment intent determined as curative by medical oncologist * scheduled for chemotherapy with or without non-cranial radiotherapy * no prior history of chemotherapy and/or radiotherapy * able to read and understand English * capable of giving informed consent (or obtaining parents' consent if required) Exclusion Criteria: * physically or mentally incapable of providing verbal/written consent * diagnosed with primary or metastatic brain tumor(s) or relapsed disease * treatment includes intrathecal or intraventricular chemotherapy * evidence of psychosis or underlying neuropsychiatric illness that may impair cognitive abilities * have immediate family member who is enrolled as in the healthy control arm * any contraindication to MRI as stated in the study protocol including: pregnancy, metal fragments/implants in body, known claustrophobia, and non-removable metal orthodontic braces, metallic retainers and oral wires
References
Publications (17)
- BACKGROUNDSender L, Zabokrtsky KB. Adolescent and young adult patients with cancer: a milieu of unique features. Nat Rev Clin Oncol. 2015 Aug;12(8):465-80. doi: 10.1038/nrclinonc.2015.92. Epub 2015 May 26. PMID 26011488
- BACKGROUNDNass SJ, Beaupin LK, Demark-Wahnefried W, Fasciano K, Ganz PA, Hayes-Lattin B, Hudson MM, Nevidjon B, Oeffinger KC, Rechis R, Richardson LC, Seibel NL, Smith AW. Identifying and addressing the needs of adolescents and young adults with cancer: summary of an Institute of Medicine workshop. Oncologist. 2015 Feb;20(2):186-95. doi: 10.1634/theoncologist.2014-0265. Epub 2015 Jan 7. PMID 25568146
- BACKGROUNDTai E, Buchanan N, Townsend J, Fairley T, Moore A, Richardson LC. Health status of adolescent and young adult cancer survivors. Cancer. 2012 Oct 1;118(19):4884-91. doi: 10.1002/cncr.27445. Epub 2012 Jun 11. PMID 22688896
- BACKGROUNDAhles TA, Root JC, Ryan EL. Cancer- and cancer treatment-associated cognitive change: an update on the state of the science. J Clin Oncol. 2012 Oct 20;30(30):3675-86. doi: 10.1200/JCO.2012.43.0116. Epub 2012 Sep 24. PMID 23008308
- BACKGROUNDVardy J. Cognitive function in breast cancer survivors. Cancer Treat Res. 2009;151:387-419. doi: 10.1007/978-0-387-75115-3_24. No abstract available. PMID 19593525
- BACKGROUNDCheung YT, Shwe M, Tan YP, Fan G, Ng R, Chan A. Cognitive changes in multiethnic Asian breast cancer patients: a focus group study. Ann Oncol. 2012 Oct;23(10):2547-2552. doi: 10.1093/annonc/mds029. Epub 2012 Mar 6. PMID 22396443
- BACKGROUNDGuy GP Jr, Yabroff KR, Ekwueme DU, Smith AW, Dowling EC, Rechis R, Nutt S, Richardson LC. Estimating the health and economic burden of cancer among those diagnosed as adolescents and young adults. Health Aff (Millwood). 2014 Jun;33(6):1024-31. doi: 10.1377/hlthaff.2013.1425.