Impact of a Breast cAncer Survivorship Interprofessional Community Care Model
NCT ID: NCT04660188
Last Updated: 2022-11-23
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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COMPLETED
NA
70 participants
INTERVENTIONAL
2021-03-01
2022-07-20
Brief Summary
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Detailed Description
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The American Society of Clinical Oncology (ASCO) advocates a collaborative survivorship care model involving the transition of cancer survivors from specialist to primary care setting via a risk-stratified approach. While the proposed collaborative model is promising and appealing, its feasibility and applicability in the local Asian setting considering cultural and socioeconomic factors is unknown. Furthermore, two major gaps exist: (i) there is a lack of comprehensive evaluation of structural factors in care coordination and clinical outcomes determination; and (ii) the potential of community pharmacists in cancer survivorship care is not maximized.
The main objective of the study is to assess the feasibility and acceptability of the BASIC care model for implementation amongst BCS and healthcare providers. The secondary objective addresses the effectiveness of BASIC model by providing robust parameters estimation for the physical symptom distress burden and quality of life outcome measures that will be used for sample size calculation in the eventual main trial.
This will be a pragmatic, randomized, controlled, pilot trial conducted at the National Cancer Centre Singapore (NCCS), participating SingHealth polyclinics and Watsons community pharmacies over a period of 2 years. Participants will be randomized into the multidisciplinary collaborative care arm or attentional control arm in a 1:1 ratio, stratified by the absence versus presence of comorbidities. In the multidisciplinary collaborative care arm, participants will experience a 12-month cancer follow-up schedule via a shared-care approach. In the attentional control arm, participants will continue with usual care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Multidisciplinary collaborative care arm
Post-treatment clinical follow-up visits will be staggered between the oncologist and a dedicated PCP. A patient navigator will be assigned to each study participant to conduct follow-up sessions over the phone regularly at an approximate interval of 3 months.
Multidisciplinary collaborative care arm
Study participants will be cared for by a team of healthcare professionals; an oncologist, a PCP and a pharmacist navigator.
Attentional control arm
BCS will receive follow-up care by their oncologists and any other healthcare providers under existing usual care practices at NCCS.
No interventions assigned to this group
Interventions
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Multidisciplinary collaborative care arm
Study participants will be cared for by a team of healthcare professionals; an oncologist, a PCP and a pharmacist navigator.
Eligibility Criteria
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Inclusion Criteria
* Received a formal diagnosis of breast cancer.
* At least three years after active primary treatment including surgery, chemotherapy, radiotherapy (if any) and targeted therapy (if any).
* Ascertained to be a low-risk cancer survivor by oncologist.
* Ambulatory with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, indicative of adequate functioning capacity to travel and receive follow-up care at polyclinics.
* Able to read and understand either English or Mandarin
Exclusion Criteria
* Unwell or unable to comply with the study protocol that involves questionnaires completion.
21 Years
FEMALE
No
Sponsors
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National University of Singapore
OTHER
SingHealth Polyclinics
OTHER
National Cancer Centre, Singapore
OTHER
Responsible Party
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Principal Investigators
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Rose WY Fok
Role: PRINCIPAL_INVESTIGATOR
National Cancer Centre, Singapore
Locations
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National Cancer Center Singapore
Singapore, , Singapore
Countries
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References
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Halpern MT, Viswanathan M, Evans TS, Birken SA, Basch E, Mayer DK. Models of Cancer Survivorship Care: Overview and Summary of Current Evidence. J Oncol Pract. 2015 Jan;11(1):e19-27. doi: 10.1200/JOP.2014.001403. Epub 2014 Sep 9.
Grunfeld E, Fitzpatrick R, Mant D, Yudkin P, Adewuyi-Dalton R, Stewart J, Cole D, Vessey M. Comparison of breast cancer patient satisfaction with follow-up in primary care versus specialist care: results from a randomized controlled trial. Br J Gen Pract. 1999 Sep;49(446):705-10.
Grunfeld E, Levine MN, Julian JA, Coyle D, Szechtman B, Mirsky D, Verma S, Dent S, Sawka C, Pritchard KI, Ginsburg D, Wood M, Whelan T. Randomized trial of long-term follow-up for early-stage breast cancer: a comparison of family physician versus specialist care. J Clin Oncol. 2006 Feb 20;24(6):848-55. doi: 10.1200/JCO.2005.03.2235. Epub 2006 Jan 17.
Blaauwbroek R, Tuinier W, Meyboom-de Jong B, Kamps WA, Postma A. Shared care by paediatric oncologists and family doctors for long-term follow-up of adult childhood cancer survivors: a pilot study. Lancet Oncol. 2008 Mar;9(3):232-8. doi: 10.1016/S1470-2045(08)70034-2. Epub 2008 Feb 20.
Ke Y, Ng T, Chan A. Survivorship care models for breast cancer, colorectal cancer, and adolescent and young adult (AYA) cancer survivors: a systematic review. Support Care Cancer. 2018 Jul;26(7):2125-2141. doi: 10.1007/s00520-018-4197-y. Epub 2018 Apr 25.
Ng T, Toh MR, Cheung YT, Chan A. Follow-up care practices and barriers to breast cancer survivorship: perspectives from Asian oncology practitioners. Support Care Cancer. 2015 Nov;23(11):3193-200. doi: 10.1007/s00520-015-2700-2. Epub 2015 Mar 21.
Chan A, Lum ZK, Ng T, Eyob T, Wang XJ, Chae JW, Dorajoo S, Shwe M, Gan YX, Fok R, Loh KW, Tan YP, Fan G. Perceptions and Barriers of Survivorship Care in Asia: Perceptions From Asian Breast Cancer Survivors. J Glob Oncol. 2016 Jun 8;3(2):98-104. doi: 10.1200/JGO.2016.004929. eCollection 2017 Apr.
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.
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.
Breitenstein SM, Gross D, Garvey CA, Hill C, Fogg L, Resnick B. Implementation fidelity in community-based interventions. Res Nurs Health. 2010 Apr;33(2):164-73. doi: 10.1002/nur.20373.
van Onzenoort HA, Menger FE, Neef C, Verberk WJ, Kroon AA, de Leeuw PW, van der Kuy PH. Participation in a clinical trial enhances adherence and persistence to treatment: a retrospective cohort study. Hypertension. 2011 Oct;58(4):573-8. doi: 10.1161/HYPERTENSIONAHA.111.171074. Epub 2011 Aug 8.
Gao F, Ng GY, Cheung YB, Thumboo J, Pang G, Koo WH, Sethi VK, Wee J, Goh C. The Singaporean English and Chinese versions of the EQ-5D achieved measurement equivalence in cancer patients. J Clin Epidemiol. 2009 Feb;62(2):206-13. doi: 10.1016/j.jclinepi.2008.03.007. Epub 2008 Jul 10.
Cheung YB, Thumboo J, Goh C, Khoo KS, Che W, Wee J. The equivalence and difference between the English and Chinese versions of two major, cancer-specific, health-related quality-of-life questionnaires. Cancer. 2004 Dec 15;101(12):2874-80. doi: 10.1002/cncr.20681.
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.
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.
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
Ng T, Dorajoo SR, Cheung YT, Lam YC, Yeo HL, Shwe M, Gan YX, Foo KM, Loh WK, Koo SL, Jain A, Lee GE, Dent R, Yap YS, Ng R, Chan A. Distinct and heterogeneous trajectories of self-perceived cognitive impairment among Asian breast cancer survivors. Psychooncology. 2018 Apr;27(4):1185-1192. doi: 10.1002/pon.4635. Epub 2018 Feb 1.
Related Links
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Singapore Cancer Registry: Annual Registry Report 2015
Speech by Minister of State for Health, Dr Lam Pin Min, at the MOH Committee of Supply debate 2017
Sympton burden and medication use in adult sarcoma patients
Other Identifiers
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2019/2452
Identifier Type: -
Identifier Source: org_study_id
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