Trial Comparing Active Intervention At Diagnosis With Usual Care to Improve Psycho-social Care in AYAO

Not Applicable

Completed

• Conditions: Lymphoma; Sarcoma; Carcinoma; Cancer
• Interventions: Other: Supportive Care Program; Other: Usual Care

• Registration Number: NCT03515174
• Lead Sponsor: National Cancer Centre, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-28
• Study Start: 2018-04-16
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-03
• Primary Completion: 2022-07-31
• Study Completion: 2023-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Program	Supportive Care Program	Patients will participate in a structured supportive care program.
Control Group	Usual Care	Patients in the control group will receive usual care.
Interventional Program	Usual Care	Patients will participate in a structured supportive care program.

Primary Outcome Measures

Name	Time	Method
Extent of symptom burden measured using Rotterdam Symptom Checklist (RSCL)	6 months post recruitment	The 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 Scales	6 months post recruitment	Pediatrics 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 Outcome Measures

Name	Time	Method
Satisfaction Questionnaire	At 3 months from baseline	The 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.
Patients' distress levels using the National Comprehensive Cancer Network (NCCN) Distress Thermometer	6 months post recruitment	NCCN 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.

Trial Locations

Locations (1)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore