Accessible Cancer Care to Enable Support for Survivors Programme
NCT ID: NCT04014309
Last Updated: 2019-11-29
Study Results
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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UNKNOWN
NA
226 participants
INTERVENTIONAL
2019-10-01
2021-10-31
Brief Summary
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This study hypothesized that breast and gynecological cancer patients receiving timely screening for distress and appropriate supportive care services will report better improvement in quality of life as compared to non-recipients under usual care. This pilot study then aims to evaluate:
(i) The effectiveness of the program on a patient level in improving the quality of life and the symptom burden of patients requiring further supportive services.
(ii) The feasibility of the program's implementation on a health-system level among breast and gynaecological cancer patients in the outpatient oncology clinics at a specialty cancer centre.
Detailed Description
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Patients' quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and compared longitudinally between both study arms at a 3-months interval. Additionally, physical and psychological symptom distress levels will be compared using the Rotterdam Symptom Checklist (RSCL).
For patients who receive symptom-specific services, additional questionnaires will be completed before and after they have received the service. They include the following: Multi-dimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) for fatigue, Patient Neurotoxicity Questionnaire (PNQ) for neuropathy, Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog v3.0) for cognitive function, and Patient-Reported Arthralgia Inventory (PRAI) for arthralgia.
An economic evaluation will be conducted using healthcare resource utilization and cost data gathered from health records and surveys including the Work Productivity and Activity Impairment (WPAI) questionnaire. Process outcomes of the program delivery will also be obtained to assess its feasibility by monitoring the referral patterns to supportive care nurse and adherence to screening or appointments. Lastly, patient satisfaction and clinicians acceptability of the program will be assessed via questionnaires.
Results from this study on the program's feasibility and effectiveness among breast and gynecological cancer patients are crucial to highlight potential implementation barriers and utility for patients before extending to other cancer types. Furthermore, results can shed a light on the program's scalability for future integration into routine care. This compelling initiative will contribute to the institution of integrated and coordinated rehabilitative and specialized clinics services to address supportive and survivorship needs of cancer patients across the continuum in the long run.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Supportive and survivorship care program
Routine distress screening will be conducted using the Distress Thermometer (DT) and an accompanying problem list. Participants will complete the screening tool before their consults with oncologists and the results will be stored in their medical records. During the consult, oncologists will review the DT scores and problem list with each participant to provide the corresponding educational materials, advice or referrals. Highly distressed participants may be referred by oncologists to the supportive care nurses (SCN) for further triage and review.
Supportive and survivorship care program
Provision of routine systematic screening using distress thermometer and problem list with accompanying supportive care nurse service.
Usual care
No routine distress screening will be performed.
Usual care
Usual care
Interventions
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Supportive and survivorship care program
Provision of routine systematic screening using distress thermometer and problem list with accompanying supportive care nurse service.
Usual care
Usual care
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed patients receiving subsequent follow-up care in NCCS
* Able to read and understand English or Chinese
* Capable of providing informed consent
Exclusion Criteria
* Patients under active care by the palliative care team
21 Years
FEMALE
No
Sponsors
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National Cancer Centre, Singapore
OTHER
National University of Singapore
OTHER
Responsible Party
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Alexandre Chan
Associate Professor
Principal Investigators
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Alexandre Chan, PharmD
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore, National Cancer Centre Singapore
Locations
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National Cancer Centre Singapore
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Alexandre Chan, Pharm.D
Role: primary
References
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Loh KW, Ng T, Choo SP, Saw HM, Mahendran R, Tan C, Chang GCY, Ong YJ, Yee ACP, Chan A, Soo KC. Cancer Supportive and Survivorship Care in Singapore: Current Challenges and Future Outlook. J Glob Oncol. 2018 Sep;4:1-8. doi: 10.1200/JGO.17.00117.
Tan ML, Idris DB, Teo LW, Loh SY, Seow GC, Chia YY, Tin AS. Validation of EORTC QLQ-C30 and QLQ-BR23 questionnaires in the measurement of quality of life of breast cancer patients in Singapore. Asia Pac J Oncol Nurs. 2014 Apr-Jun;1(1):22-32. doi: 10.4103/2347-5625.135817.
de Haes JC, van Knippenberg FC, Neijt JP. Measuring psychological and physical distress in cancer patients: structure and application of the Rotterdam Symptom Checklist. Br J Cancer. 1990 Dec;62(6):1034-8. doi: 10.1038/bjc.1990.434.
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.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
Cheung YB, Neo SHS, Teo I, Yang GM, Lee GL, Thumboo J, Chia JWK, Koh ARX, Qu DLM, Che WWL, Lau A, Wee HL. Development and evaluation of a quality of life measurement scale in English and Chinese for family caregivers of patients with advanced cancers. Health Qual Life Outcomes. 2019 Feb 14;17(1):35. doi: 10.1186/s12955-019-1108-y.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
Chan A, Lew C, Wang XJ, Ng T, Chae JW, Yeo HL, Shwe M, Gan YX. Psychometric properties and measurement equivalence of the Multidimensional Fatigue Syndrome Inventory- Short Form (MFSI-SF) amongst breast cancer and lymphoma patients in Singapore. Health Qual Life Outcomes. 2018 Jan 19;16(1):20. doi: 10.1186/s12955-018-0846-6.
Kuroi K, Shimozuma K, Ohashi Y, Hisamatsu K, Masuda N, Takeuchi A, Aranishi T, Morita S, Ohsumi S, Hausheer FH. Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study). Support Care Cancer. 2009 Aug;17(8):1071-80. doi: 10.1007/s00520-008-0550-x. Epub 2008 Dec 17.
Castel LD, Wallston KA, Saville BR, Alvarez JR, Shields BD, Feurer ID, Cella D. Validity and reliability of the Patient-Reported Arthralgia Inventory: validation of a newly-developed survey instrument to measure arthralgia. Patient Relat Outcome Meas. 2015 Jul 28;6:205-14. doi: 10.2147/PROM.S47997. eCollection 2015.
van Nuenen FM, Donofrio SM, Tuinman MA, van de Wiel HB, Hoekstra-Weebers JE. Feasibility of implementing the 'Screening for Distress and Referral Need' process in 23 Dutch hospitals. Support Care Cancer. 2017 Jan;25(1):103-110. doi: 10.1007/s00520-016-3387-8. Epub 2016 Aug 26.
Ristevski E, Regan M, Jones R, Breen S, Batson A, McGrail MR. Cancer patient and clinician acceptability and feasibility of a supportive care screening and referral process. Health Expect. 2015 Jun;18(3):406-18. doi: 10.1111/hex.12045. Epub 2013 Jan 31.
Cocks K, King MT, Velikova G, de Castro G Jr, Martyn St-James M, Fayers PM, Brown JM. Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Eur J Cancer. 2012 Jul;48(11):1713-21. doi: 10.1016/j.ejca.2012.02.059. Epub 2012 Mar 12.
Other Identifiers
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CIRB Ref. No: 2019/2090
Identifier Type: -
Identifier Source: org_study_id