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

Study Overview
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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.

Official Title
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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

Conditions
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Carcinoma, Lymphoma, Sarcoma, Cancer

Intervention / Treatment
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* Other: Supportive Care Program
* Other: Usual Care


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoma, Adolescent and Young Adult Oncology, Carcinoma, Lymphoma, Cancer