Impact of a Breast cAncer Survivorship Interprofessional Community Care Model (BASIC)

November 21, 2022 updated by: National Cancer Centre, Singapore

Impact of a Breast cAncer Survivorship Interprofessional Community Care Model (BASIC): A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In Singapore, breast cancer accounts for approximately 30% of all new cancer cases. With an overall 10-year age-standardized survival rate of 50%, it is estimated that 900 BCS will require dedicated cancer survivorship care in Singapore annually. However, the current oncologist-centric survivorship model adopted in Singapore will not be sustainable to respond to the rising demand for survivorship care services. This inability to cope with the growing demand poses a major challenge to the health system and accentuates an emerging need for an alternative evidence-based care model to support BCS and healthcare providers in achieving efficient and effective cancer survivorship care.

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169690
        • National Cancer Center Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 21 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Multidisciplinary collaborative care arm
Study participants will be cared for by a team of healthcare professionals; an oncologist, a PCP and a pharmacist navigator.
No Intervention: Attentional control arm
BCS will receive follow-up care by their oncologists and any other healthcare providers under existing usual care practices at NCCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participants' health-related quality of life
Time Frame: Baseline, every 3 months up to 12 months
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
Time Frame: Baseline, every 3 months up to 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants' satisfaction with the shared-care model
Time Frame: One year post-intervention
Participants in the intervention arm who received the intervention will complete an overall satisfaction questionnaire. This questionnaire is adapted from Patient Experience Measures from the CAHPS Cancer Care Survey. It comprises of 21 items divided into 4 sections evaluating (1) care accessibility and adequacy (8 items); (2) overall communication (5 items); (3) care coordination (3 items); and (4) satisfaction with care (5 items). 20 items will be rated on a Likert scale, where a higher score indicating better experience and satisfaction. One item is an open response question for participants' feedback.
One year post-intervention
Change in participants' health utilities
Time Frame: Baseline, every 3 months up to 12 months
The EuroQol 5-Dimensions (EQ-5D-5L) has five dimensions: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression. Each dimension will be rated on a 5-point Likert scale ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems"), where a higher score indicating greater severity. The second part consists of a visual analogue scale ranging from 0 (worst health imagined) to 100 (best health imagined) where participants will mark on the scale and write down the corresponding number to indicate their health state. Results from the EQ-5D-5L will be used to derive preference-based measures of health-related quality of life to estimate health utilities.
Baseline, every 3 months up to 12 months
Change in healthcare cost and productivity
Time Frame: Baseline, every 6 months up to 12 months
A healthcare utilization survey is used where open-ended questions require participants to report their expenditure to outpatient clinics, hospitalization episodes and on medication. The second part gathers information on the work-related outcomes including change in job scope, paid/ unpaid leave and change in productivity.
Baseline, every 6 months up to 12 months
Rate of adherence to breast cancer survivorship care guidelines
Time Frame: From start to end of study, up to 12 months
The rate of adherence to evidence-based breast cancer survivorship care guidelines will be determined by the proportion of participants who satisfied each of the following areas based on documentation of review or scans/ procedures ordered: (1) annual mammograms; (2) screening for secondary primary cancers; (3) assessment and management of physical and psychosocial long-term and late effects of breast cancer or treatment; (4) health promotion; and (5) care coordination.
From start to end of study, up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

SingHealth Polyclinics
National University of Singapore

Investigators

  • Principal Investigator: Rose WY Fok, National Cancer Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 21, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/2452

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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