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Completed

NCT Number: NCT03515174

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

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.

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Key information

Age range

16 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre Singapore

Singapore, 169610

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supportive Care Program

Other

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.

Usual Care

Other

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.

Primary outcomes

  1. Extent of symptom burden measured using Rotterdam Symptom Checklist (RSCL)

    Time frame: 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.

  2. Health-related quality of life using PedsQL 4.0 Generic Core Scales

    Time frame: 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 outcomes

  1. Patients' distress levels using the National Comprehensive Cancer Network (NCCN) Distress Thermometer

    Time frame: 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.

  2. Satisfaction Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
May 3, 2018
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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