Feasibility, Acceptability and Preliminary Efficacy of the New Iteration of the Innovative Smartphone-based Care Solution for Women With Breast Cancer Undergoing Chemotherapy (iCareBreast+): A Pilot Study Research Proposal

The overall aim of the study is to evaluate the feasibility, acceptability and preliminary effects of the next iteration of iCareBreast+, an innovative breast care e-support intervention programme, by refining existing contents and building new contents based on comprehensive assessment of breast cancer women's needs and preferences among breast cancer patients undergoing chemotherapy.

The specific objectives of this study are:

1. To develop a new iteration of an innovative smartphone-based self-care solution for patients with breast cancer undergoing chemotherapy (iCareBreast+);
2. To assess the feasibility and acceptability of iCareBreast+; and
3. To explore the preliminary effects of iCareBreast+ on the primary outcome of self-efficacy, and knowledge of breast cancer treatment, as well as secondary outcomes including anxiety, depression, health-related quality of life (HRQoL), social support and satisfaction with oncologic care.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Routine care; Other: Routine care + iCareBreast+ mobile app

Detailed Description

A two-group pilot randomized controlled trial with pretest and post-test will be conducted in a tertiary hospital in Singapore. Women with breast cancer requiring chemotherapy (n = 40) will be recruited and randomly allocated to the intervention group (receiving iCareBreast+ and routine care) or the control group (routine care only). Feasibility data (patient recruitment and attrition, usefulness, ease of use, strengths and weaknesses), as well as app quality data will be collected. Health outcomes will be measured using validated instruments at baseline and immediately after the 2-month intervention.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed; Phone Number: +65 64368000; Email: ryan.shea.tan.y.c@singhealth.com.sg
• Study Contact Backup: Name: Bernard JG Chua, MBBS (Hons)(Aus), MRCP (UK); Phone Number: +65 64368000; Email: bernard.chua.j.g@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National Cancer Centre, Singapore
    • Contact: Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Women who:

• are the age of 21 years old and above at the point of recruitment;
• are diagnosed with stage 1-3 breast cancer;
• will undergo chemotherapy first time (initiating or up to #4 cycles of chemo is acceptable);
• can speak, read and write in English or Mandarin; and
• has access to and able to use smart phone.

Exclusion Criteria:

Those who :

• are with a history of or concurrent other cancer types;
• have been suffering from psychiatric illness (e.g., schizophrenia), anxiety disorder or other mood disorder or impaired cognitive function;
• have alcohol or substance abuse within the previous year;
• are undergoing concurrent psychosocial interventions; and
• have been in the bereavement period in the last 6 months
• are in their pregnancy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Other: Routine care + iCareBreast+ mobile app; Routine care provided by NCCS (identical to the control group) along with access to the iCareBreast+ mobile app
Experimental: Control Group	Other: Routine care; Routine care provided by NCCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility of research method and Intervention	Participants recruitment and attrition rates.	Throughout data collection period, estimated up to six months or until last subject with last visit completion whichever is later.
The acceptability of intervention	Process evaluation (semi-structured interview) and app quality (mobile app rating scale score)	After intervention (two months immediately post intervention)
The impact of psychosocial intervention (iCareBreast+ app) on cancer self-efficacy	Changes of Self-efficacy Score (Self-efficacy Score from the cancer Behaviour Inventory-Brief (CBI-B) survey).	Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on knowledge of breast cancer treatment	Changes of knowledge Score (Knowledge Score from a scale of 0-10)	Baseline (on enrolment day), and after Intervention (two months immediately post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of psychosocial Intervention (iCareBreast+ app) on anxiety and depression	Changes of anxiety and depression Score (Hospital Anxiety and Depression scale).	Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on cancer related quality of life	Changes of Cancer related quality of lief Score (Functional Assessment of Cancer Therapy-Breast (FACT-B))	Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on cancer self-efficacy	Changes of Social support Score (The Medical Outcomes Study Social Support Survey).	Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on satisfaction of oncological care	Satisfaction Score (Satisfaction Score from a single item 6-point Ordinal Descriptive Scale).	After Intervention (two months immediately post intervention)

Collaborators and Investigators

• Sponsor: National Cancer Centre, Singapore
• Collaborators: Buddy Healthcare Ltd OY
• Investigators: Principal Investigator: Dr Ryan Shea YC TAN, MBBS, MRCP(UK), MMed, National Cancer Centre, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2025
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: May 9, 2025
• First Submitted That Met QC Criteria: May 9, 2025
• First Posted (Actual): May 18, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; Randomized Controlled Trial; mHealth; Chemotherapy; Self-efficacy; Digital Health; Mobile health; Psychosocial
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: iCareBreast+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No