Clinical trial · Interventional
Trial Comparing Active Intervention At Diagnosis With Usual Care to Improve Psycho-social Care in AYAO
A Randomized Controlled Trial Comparing Active Intervention at Diagnosis With Usual Care to Improve the Psycho-social Care in the Adolescent and Young Adult Oncology (AYAO) Population
- 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 (AYA) patients experience significant distress in specific areas at diagnosis. The investigators hypothesize that providing developmentally-appropriate AYA-specific psychosocial care, with an individualized multi-disciplinary program will alleviate this distress, as well as improve health-related quality of life (HRQOL). The investigators' primary aim is to evaluate the impact of psychosocial interventions on HRQOL. The secondary aims are to firstly identify the types of psychosocial distress experienced and secondly, to assess the feasibility of implementing a psychosocial screening and intervention program amongst AYA patients newly diagnosed with cancer.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supportive Care Program | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional Program
- description
- Patients will participate in a structured supportive care program.
- interventionNames
- Other: Supportive Care Program
- Other: Usual Care
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Patients in the control group will receive usual care.
- interventionNames
- Other: Usual Care
Primary outcomes (2)
- measure
- Extent of symptom burden measured using Rotterdam Symptom Checklist (RSCL)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 39 Years
Show eligibility criteria text
Inclusion Criteria: * 16 to 39 years old * Newly diagnosed with any form of cancers * Capable of giving informed consent (by patients or parents, whichever applicable) * Ability to understand and willingness to sign a written informed consent document * Able to speak and understand English * Able to commit to attending the 3 info-educational sessions as well as patient-directed additional visits Exclusion Criteria: * Patients with uncontrolled brain metastasis. * Patients who are unable to commit to attend all 3 info-educational sessions * Patients who are unable to communicate in English.
References
Publications (10)
- BACKGROUNDZebrack B, Isaacson S. Psychosocial care of adolescent and young adult patients with cancer and survivors. J Clin Oncol. 2012 Apr 10;30(11):1221-6. doi: 10.1200/JCO.2011.39.5467. Epub 2012 Mar 12. PMID 22412147
- BACKGROUNDNational Cancer Institute, LIVESTRONG Young Adult Alliance. Closing the Gap: Research and Care Imperatives for Adolescents and Young Adults with Cancer (Report of the Adolescent and Young Adult Oncology Progress Review Group).; 2006. https://www.livestrong.org/content/closing-gap-research-and-care-imperatives-adolescents-and-young-adults-cancer.
- BACKGROUNDRichter D, Koehler M, Friedrich M, Hilgendorf I, Mehnert A, Weissflog G. Psychosocial interventions for adolescents and young adult cancer patients: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2015 Sep;95(3):370-86. doi: 10.1016/j.critrevonc.2015.04.003. Epub 2015 Apr 16. PMID 25922217
- BACKGROUNDChan A, Gan YX, Oh SK, Ng T, Shwe M, Chan R, Ng R, Goh B, Tan YP, Fan G. A culturally adapted survivorship programme for Asian early stage breast cancer patients in Singapore: A randomized, controlled trial. Psychooncology. 2017 Oct;26(10):1654-1659. doi: 10.1002/pon.4357. Epub 2017 Jan 25. PMID 28024163
- BACKGROUNDLim HA, Mahendran R, Chua J, Peh CX, Lim SE, Kua EH. The Distress Thermometer as an ultra-short screening tool: a first validation study for mixed-cancer outpatients in Singapore. Compr Psychiatry. 2014 May;55(4):1055-62. doi: 10.1016/j.comppsych.2014.01.008. Epub 2014 Jan 18. PMID 24556515
- BACKGROUNDMahendran R, Lim HA, Chua J, Lim SE, Kua EH. Psychosocial concerns of cancer patients in Singapore. Asia Pac J Clin Oncol. 2017 Apr;13(2):e96-e103. doi: 10.1111/ajco.12344. Epub 2015 Apr 9. PMID 25856735
- BACKGROUNDWatson M, Law M, Maguire B, et al. Further development of a quality of life measure for cancer patients; the Rotterdam Symptom Checklist (revised). Psychooncology. 1992;1:35-44.