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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03515174
Enrollment
70
Registered
2018-05-03
Start date
2018-04-16
Completion date
2023-02-28
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Carcinoma, Lymphoma, Sarcoma

Keywords

Adolescent and Young Adult Oncology, Carcinoma, Lymphoma, Sarcoma, Cancer

Brief summary

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.

Interventions

This program takes place within one month post-diagnosis of cancer. It will include three info-educational session. After that, recommendations for further consultation with specific healthcare professionals will be made based on the concerns and needs of patients at baseline. Patient will also be given usual care.

OTHERUsual Care

Patients will be provided with an information booklet by the study team on self-management of cancer- and treatment-related symptoms, which is routinely provided by the National Cancer Centre of Singapore (NCCS) after cancer diagnosis. Usual general advice is provided by the medical oncologists during the routine consultations.

Sponsors

National Cancer Centre, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 39 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Extent of symptom burden measured using Rotterdam Symptom Checklist (RSCL)6 months post recruitmentThe Rotterdam Symptom Checklist (RSCL) is a self-report measure to assess the quality of life of cancer patients. It uses a 4-point Likert-type scales (not at all, a little, quite a bit, very much) to measure four domains, namely the physical symptom distress (23 items), psychological distress (7 items) activity level (8 items) overall valuation of life (1 item). The higher the score, the higher the level of burden or impairment. Standardized scores of scales can also be obtained when comparing different scales by transforming raw scores into scores on a 100-point scale using the formula \[(raw scale score - minimum raw score) / (maximum - minimum score)\] x 100 = transformed score.
Health-related quality of life using PedsQL 4.0 Generic Core Scales6 months post recruitmentPediatrics Quality of Life Inventory (PedsQL) is a model used to measure health-related quality of life (HRQOL) in adolescents and young adults by generating a physical health summary score and psychosocial health summary score both ranging from 0-100, whereby a higher score suggests a better HRQOL. It encompasses physical, mental, and social health, the core dimensions of health defined by the World Health Organization, as well as is school functioning to generate pediatric HRQOL.

Secondary

MeasureTime frameDescription
Patients' distress levels using the National Comprehensive Cancer Network (NCCN) Distress Thermometer6 months post recruitmentNCCN Distress Thermometer is a screening tool that measures distress on a 0 to 10 scale, whereby 0 indicates No distress and 10 indicates Extreme distress. The Distress Thermometer also includes a problem checklist to identify problems that contribute to the score. These include practical problems, family problems, emotional problems, spiritual/religious concerns and physical problems that cancer patients may have.
Satisfaction QuestionnaireAt 3 months from baselineThe satisfaction questionnaire is adapted from a client satisfaction questionnaire incorporating questions about communication with healthcare providers. Patients rate their satisfaction of the info-education sessions - the way it is conducted and content and if their needs have been met on a Likert Scale. This ranges from 1 to 5: with 1 being strongly disagree and, 2 being disagree, 3 being neutral, 4 being agree and 5 being strongly agree. The total score of each individual item is summed up, with higher scores indicating a favourable response to the info-educational sessions.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026