NCT03515174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

4.3 years

First QC Date

March 28, 2018

Last Update Submit

April 8, 2025

Conditions

CarcinomaLymphomaSarcomaCancer

Keywords

Adolescent and Young Adult OncologyCarcinomaLymphomaSarcomaCancer

Outcome Measures

Primary Outcomes (2)

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

    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

    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 Outcomes (2)

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

    6 months post recruitment

  • Satisfaction Questionnaire

    At 3 months from baseline

Study Arms (2)

Interventional Program

EXPERIMENTAL

Patients will participate in a structured supportive care program.

Other: Supportive Care ProgramOther: Usual Care

Control Group

ACTIVE COMPARATOR

Patients in the control group will receive usual care.

Other: Usual Care

Interventions

Supportive Care ProgramOTHER

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.

Interventional Program
Usual CareOTHER

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.

Control GroupInterventional Program

Eligibility Criteria

Age16 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

Related Publications (10)

  • Zebrack 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: 22412147BACKGROUND

  • National 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.

    BACKGROUND

  • Richter 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: 25922217BACKGROUND

  • Chan 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: 28024163BACKGROUND

  • Lim 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: 24556515BACKGROUND

  • Mahendran 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: 25856735BACKGROUND

  • Watson 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.

    BACKGROUND

  • Ewing JE, King MT, Smith NF. Validation of modified forms of the PedsQL generic core scales and cancer module scales for adolescents and young adults (AYA) with cancer or a blood disorder. Qual Life Res. 2009 Mar;18(2):231-44. doi: 10.1007/s11136-008-9424-4. Epub 2009 Jan 23.

    PMID: 19165624BACKGROUND

  • Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

    PMID: 10245370BACKGROUND

  • Mitchell AJ. Short screening tools for cancer-related distress: a review and diagnostic validity meta-analysis. J Natl Compr Canc Netw. 2010 Apr;8(4):487-94. doi: 10.6004/jnccn.2010.0035.

    PMID: 20410338BACKGROUND

MeSH Terms

Conditions

CarcinomaLymphomaSarcomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Connective and Soft Tissue

Study Officials

  • Eileen YL Poon, MD

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2018

First Posted

May 3, 2018

Study Start

April 16, 2018

Primary Completion

July 31, 2022

Study Completion

February 28, 2023

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)