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

Primary Purpose

Carcinoma, Lymphoma, Sarcoma

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Supportive Care Program
Usual Care
Sponsored by
National Cancer Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carcinoma focused on measuring Adolescent and Young Adult Oncology, Carcinoma, Lymphoma, Sarcoma, Cancer

Eligibility Criteria

16 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Centre Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional Program

Control Group

Arm Description

Patients will participate in a structured supportive care program.

Patients in the control group will receive usual care.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 28, 2018
Last Updated
December 1, 2022
Sponsor
National Cancer Centre, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03515174
Brief Title
Trial Comparing Active Intervention At Diagnosis With Usual Care to Improve Psycho-social Care in AYAO
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Lymphoma, Sarcoma, Cancer
Keywords
Adolescent and Young Adult Oncology, Carcinoma, Lymphoma, Sarcoma, Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional Program
Arm Type
Experimental
Arm Description
Patients will participate in a structured supportive care program.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients in the control group will receive usual care.
Intervention Type
Other
Intervention Name(s)
Supportive Care Program
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
Extent of symptom burden measured using Rotterdam Symptom Checklist (RSCL)
Description
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.
Time Frame
6 months post recruitment
Title
Health-related quality of life using PedsQL 4.0 Generic Core Scales
Description
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.
Time Frame
6 months post recruitment
Secondary Outcome Measure Information:
Title
Patients' distress levels using the National Comprehensive Cancer Network (NCCN) Distress Thermometer
Description
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.
Time Frame
6 months post recruitment
Title
Satisfaction Questionnaire
Description
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.
Time Frame
At 3 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen YL Poon, MD
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22412147
Citation
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.
Results Reference
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Citation
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.
Results Reference
background
PubMed Identifier
25922217
Citation
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.
Results Reference
background
PubMed Identifier
28024163
Citation
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.
Results Reference
background
PubMed Identifier
24556515
Citation
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.
Results Reference
background
PubMed Identifier
25856735
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
19165624
Citation
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.
Results Reference
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PubMed Identifier
10245370
Citation
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.
Results Reference
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PubMed Identifier
20410338
Citation
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.
Results Reference
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Trial Comparing Active Intervention At Diagnosis With Usual Care to Improve Psycho-social Care in AYAO

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