Impact of a Breast cAncer Survivorship Interprofessional Community Care Model

NCT04660188 | Completed

• 1 other identifier: 2019/2452
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

With an increase in breast cancer survivors (BCS) in Singapore, the current oncologist-centric survivorship model will not be sustainable to respond to the rising demand of survivorship care services. To meet the long-term healthcare needs of Singaporeans in a sustainable manner, the investigators propose to pilot a breast cancer survivorship inter-professional community (BASIC) care model for cancer survivorship. This pilot study aims to assess the feasibility and acceptability of this care model for implementation among BCS and healthcare providers. The investigators hypothesize that the BASIC model is feasible and acceptable to be evaluated on a larger scale. This new follow-up model can potentially reduce waiting times in tertiary centers without compromising quality of care, directly benefiting participants through more efficient follow-up sessions.

Conditions

Survivorship; Breast Cancer

Keywords

survivorship care model; breast cancer survivor; shared-care; primary care; interprofessional; cancer survivorship

Outcome Measures

Primary Outcomes (2)

• Change in participants' health-related quality of life

  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is used. The EORTC QLQ-C30 consists of five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/ vomiting and pain), a global quality of life status and six single item measures (dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial stability). All scales are scored from 0 to 100 where a higher score on functioning and global health status scales is indicative of better functioning; and a higher score on symptom scales and single items is indicative of a higher symptom burden.

  Baseline, every 3 months up to 12 months

• Change in participants' physical and psychological symptom distress levels

  The Rotterdam Symptom Checklist (RSCL) is used. The physical domain of the RSCL comprises of 23 items and the psychological distress domain comprises of 7 items. Each item will be rated on a 4-point Likert scale ("not at all", "a little", "quite a bit" and "very much"). A total physical symptom distress score can be summed to give a final score between 23 to 92, where a higher score indicates a higher symptom distress level. A total psychological distress score can be summed to give a final score between 7 to 28, where a higher score indicates a higher psychological distress level.

  Baseline, every 3 months up to 12 months

Secondary Outcomes (4)

• Participants' satisfaction with the shared-care model

  One year post-intervention

• Change in participants' health utilities

  Baseline, every 3 months up to 12 months

• Change in healthcare cost and productivity

  Baseline, every 6 months up to 12 months

• Rate of adherence to breast cancer survivorship care guidelines

  From start to end of study, up to 12 months

Study Arms (2)

Multidisciplinary collaborative care arm

EXPERIMENTAL

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.

Other: Multidisciplinary collaborative care arm

Attentional control arm

NO INTERVENTION

BCS will receive follow-up care by their oncologists and any other healthcare providers under existing usual care practices at NCCS.

Interventions

Multidisciplinary collaborative care arm OTHER

Study participants will be cared for by a team of healthcare professionals; an oncologist, a PCP and a pharmacist navigator.

Multidisciplinary collaborative care arm

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Female breast cancer survivors
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older.
• 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

You may not qualify if:

• Physically or mentally incapable of providing verbal/ written consent.
• Unwell or unable to comply with the study protocol that involves questionnaires completion.

Sponsors & Collaborators

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

Study Sites (1)

National Cancer Center Singapore

Singapore, 169690, Singapore

Location

Related Publications (17)

• 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.

  PMID: 25205779 BACKGROUND

• 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.

  PMID: 10756611 BACKGROUND

• 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.

  PMID: 16418496 BACKGROUND

• 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.

  PMID: 18282804 BACKGROUND

• 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.

  PMID: 29696424 BACKGROUND

• 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.

  PMID: 25791392 BACKGROUND

• 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.

  PMID: 28717749 BACKGROUND

• 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.

  PMID: 28024163 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

• 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.

  PMID: 20198637 BACKGROUND

• 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.

  PMID: 21825228 BACKGROUND

• 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.

  PMID: 18619790 BACKGROUND

• 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.

  PMID: 15529310 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

• 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

• 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.

  PMID: 26092476 BACKGROUND

• 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.

  PMID: 29315963 BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Rose WY Fok

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: December 9, 2020
• Study Start: March 1, 2021
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)