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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06977360
• Lead Sponsor: National Cancer Centre, Singapore

Brief Summary

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.

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 Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Study Start: 2025-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Cancer Centre, Singapore; 🇸🇬 Singapore, Singapore