Accessible Cancer Care to Enable Support for Survivors Programme

NCT04014309 | Unknown

• 1 other identifier: CIRB Ref. No: 2019/2090
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

In Singapore, cancer patients are not consistently assessed for unmet survivorship care needs and systematically identified for subsequent referral to useful care services. To address this gap, a preliminary multidisciplinary program is developed to (i) routinely screen and identify cancer patients with high distress levels, and (ii) provide appropriate care referrals after a systematic review by a supportive care nurse. 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.

Conditions

Survivorship; Breast Cancer; Gynecologic Cancer

Keywords

distress screening; supportive care; survivorship; health service; triage; breast cancer; gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Change in quality of life from baseline across all time points between the intervention and control study arm

  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) assesses cancer patients' health-related quality of life for the past week. The global quality of life status scale will be used and it is scored from 0 to 100 where a higher score is indicative of better functioning.

  Once at baseline and every 3 months for a period of 12 months

Secondary Outcomes (10)

• Proportion of patients who achieve a clinically significant improvement or deterioration in quality of life between the intervention and control study arm

  12 months post recruitment

• Physical and psychological symptom distress levels between the intervention and control study arm

  Once at baseline and every 3 months for a period of 12 months

• Quality of life of caregivers providing care to patients in the intervention study arm

  12 months post recruitment

• Fatigue levels

  Baseline and 3 months after

• Severity of neuropathy

  Baseline and 3 months after

Study Arms (2)

Supportive and survivorship care program

EXPERIMENTAL

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.

Other: Supportive and survivorship care program

Usual care

PLACEBO COMPARATOR

No routine distress screening will be performed.

Other: Usual care

Interventions

Supportive and survivorship care program OTHER

Provision of routine systematic screening using distress thermometer and problem list with accompanying supportive care nurse service.

Supportive and survivorship care program

Usual care OTHER

Usual care

Usual care

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of breast or gynaecological cancer ascertained by clinical documentation
• Newly diagnosed patients receiving subsequent follow-up care in NCCS
• Able to read and understand English or Chinese
• Capable of providing informed consent

You may not qualify if:

• Physically or mentally incapable of providing verbal / written consent
• Patients under active care by the palliative care team

Sponsors & Collaborators

• National University of Singapore: lead
• National Cancer Centre, Singapore: collaborator

Study Sites (1)

National Cancer Centre Singapore

Singapore, Singapore

RECRUITING

Related Publications (13)

• 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.

  PMID: 30241247 BACKGROUND

• 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.

  PMID: 27981079 BACKGROUND

• 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.

  PMID: 2257209 BACKGROUND

• 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.

  PMID: 24556515 BACKGROUND

• 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.

  PMID: 8433390 BACKGROUND

• 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.

  PMID: 30764839 BACKGROUND

• 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.

  PMID: 10146874 BACKGROUND

• 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.

  PMID: 29351803 BACKGROUND

• 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.

  PMID: 19089463 BACKGROUND

• 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.

  PMID: 26251635 BACKGROUND

• 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.

  PMID: 27565789 BACKGROUND

• 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.

  PMID: 23369083 BACKGROUND

• 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.

  PMID: 22418017 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alexandre Chan, PharmD

  National University of Singapore, National Cancer Centre Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Chan, PharmD

CONTACT

65-65167814; phaac@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: In this cluster randomized study, a cluster unit is defined as the clinic held by the individual oncologists who are treating eligible patients. The randomization schedule will allocate the cluster units (i.e. each oncologist and their clinic) in a 1:1 ratio to either the new supportive and survivorship care program or usual care arm. Therefore, all participants who received care from the same oncologist will have the same allocation.

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 10, 2019
• Study Start: October 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)