Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Routine care | Other | — | UNRESOLVED |
| Routine care + iCareBreast+ mobile app | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Control Group
- interventionNames
- Other: Routine care
- type
- EXPERIMENTAL
- label
- Intervention Group
- interventionNames
- Other: Routine care + iCareBreast+ mobile app
Primary outcomes (4)
- measure
- The feasibility of research method and Intervention
- timeFrame
- Throughout data collection period, estimated up to six months or until last subject with last visit completion whichever is later.
- description
- Participants recruitment and attrition rates.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available