Clinical trial NCT04660188: Impact of a Breast cAncer Survivorship Interprofessional Community Care Model
Official title: Impact of a Breast cAncer Survivorship Interprofessional Community Care Model (BASIC): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survivorship
Breast Cancer
Keywords: survivorship care model
breast cancer survivor
shared-care
primary care
interprofessional
cancer survivorship
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
name: SingHealth Polyclinics
First posted: 2020-12-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in participants' health-related quality of life
timeFrame: Baseline, every 3 months up to 12 months
measure: Change in participants' physical and psychological symptom distress levels
timeFrame: Baseline, every 3 months up to 12 months
Secondary outcomes:
measure: Participants' satisfaction with the shared-care model
timeFrame: One year post-intervention
measure: Change in participants' health utilities
timeFrame: Baseline, every 3 months up to 12 months
measure: Change in healthcare cost and productivity
timeFrame: Baseline, every 6 months up to 12 months
measure: Rate of adherence to breast cancer survivorship care guidelines
timeFrame: From start to end of study, up to 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Center Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Rose WY Fok
role: PRINCIPAL_INVESTIGATOR
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