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

NCT ID: NCT03515174

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2023-02-28

Brief Summary

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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

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Conditions

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Carcinoma Lymphoma Sarcoma Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Interventional Program

Patients will participate in a structured supportive care program.

Group Type EXPERIMENTAL

Supportive Care Program

Intervention Type 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

Intervention Type 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.

Control Group

Patients in the control group will receive usual care.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Centre, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eileen YL Poon, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

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National Cancer Centre Singapore

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type BACKGROUND
PMID: 22412147 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 25922217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28024163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24556515 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25856735 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 19165624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10245370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20410338 (View on PubMed)

Other Identifiers

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2017/2949

Identifier Type: -

Identifier Source: org_study_id

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