Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 5:24 AM
Study NCT ID:
NCT06977360
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
National Cancer Centre, Singapore
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: