NCT06977360

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: Female
• Age: 21 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Routine care	Routine care provided by NCCS
OTHER	Routine care + iCareBreast+ mobile app	Routine care provided by NCCS (identical to the control group) along with access to the iCareBreast+ mobile app

Timeline

• Start date: 2025-05-23
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2025-05-18
• Last updated: 2025-09-12

Locations

1 site across 1 country: Singapore