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

January 2, 2024 updated by: National Cancer Centre, Singapore

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 39 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Program
Patients will participate in a structured supportive care program.
Other: Supportive Care Program
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.
Other: Usual 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.
Active Comparator: Control Group
Patients in the control group will receive usual care.
Other: Usual 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post recruitment
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.
6 months post recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post recruitment
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.
At 3 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Investigators

  • Principal Investigator: Eileen YL Poon, MD, National Cancer Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2018

Primary Completion (Actual)

July 31, 2022

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 3, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/2949

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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