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

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ClinicalTrials.gov Identifier: NCT03515174
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Carcinoma Lymphoma Sarcoma Cancer Other: Supportive Care Program Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515174


Contacts
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Contact: Eileen YL Poon, MD +65 6436 8000 eileen.poon.y.l@singhealth.com.sg
Contact: Alexandre Chan, PharmD alexandre.chan@nccs.com.sg

Locations
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Singapore
National Cancer Centre Singapore Recruiting
Singapore, Singapore, 169610
Principal Investigator: Eileen YL Poon, MD         
Sponsors and Collaborators
National Cancer Centre, Singapore
Investigators
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Principal Investigator: Eileen YL Poon, MD National Cancer Centre, Singapore

Publications:
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.
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.

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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT03515174     History of Changes
Other Study ID Numbers: 2017/2949
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Centre, Singapore:
Adolescent and Young Adult Oncology
Carcinoma
Lymphoma
Sarcoma
Cancer
Additional relevant MeSH terms:
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Sarcoma
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective and Soft Tissue