iCareBreast+: a smartphone self-care app for women with breast cancer on chemotherapy
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
This pilot tests whether iCareBreast+, a smartphone self-care app, helps women with stage 1–3 breast cancer who are starting chemotherapy feel more confident, informed, and better able to manage symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 100 Years |
| Sex | Female |
| Sponsor | National Cancer Centre, Singapore Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06977360 on ClinicalTrials.gov |
What this trial studies
This two-group pilot randomized controlled trial will recruit 40 women with stage 1–3 breast cancer undergoing chemotherapy at the National Cancer Centre Singapore and randomly assign them to receive routine care plus the iCareBreast+ app or routine care alone. The app was refined using comprehensive assessments of patient needs and includes self-care content, psychosocial support resources, and interactive features delivered over a 2-month period. Feasibility and acceptability outcomes (recruitment, attrition, usability, perceived usefulness, and app quality) will be collected alongside validated measures of self-efficacy, knowledge of treatment, anxiety, depression, health-related quality of life, social support and satisfaction with oncologic care at baseline and after the intervention. This pilot will provide preliminary effect size estimates to inform a larger definitive trial.
Who should consider this trial
Good fit: Women aged 21 or older with stage 1–3 breast cancer who are initiating or within the first four cycles of chemotherapy, can read English or Mandarin, and have a smartphone are ideal candidates.
Not a fit: Patients with other active cancers, major psychiatric disorders, recent substance abuse, concurrent psychosocial interventions, recent bereavement, pregnancy, or those without smartphone access or English/Mandarin proficiency are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, the app could boost patients' confidence and knowledge, reduce anxiety, and improve quality of life during chemotherapy while complementing standard care.
How similar studies have performed: Previous small trials of smartphone-based and web-based self-management or psychosocial support for breast cancer have shown feasibility and modest improvements in knowledge, symptom management, and distress, but larger trials are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Singapore
- National Cancer Centre, Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed — National Cancer Centre, Singapore
- Study coordinator: Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed
- Email: ryan.shea.tan.y.c@singhealth.com.sg
- Phone: +65 64368000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.