National Cancer Centre, Singapore
Singapore
Location status: Recruiting
Location contact
Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed
CONTACT
NCT Number: NCT06977360
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.
Interested in participating?
Request Info21 year–100 year
Female
Interventional
Not applicable
Singapore
Location status: Recruiting
Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Women who:
Exclusion criteria
Those who :
Routine care provided by NCCS
Routine care provided by NCCS (identical to the control group) along with access to the iCareBreast+ mobile app
Time frame: 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.
Time frame: After intervention (two months immediately post intervention)
Process evaluation (semi-structured interview) and app quality (mobile app rating scale score)
Time frame: 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).
Time frame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
Changes of knowledge Score (Knowledge Score from a scale of 0-10)
Time frame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
Changes of anxiety and depression Score (Hospital Anxiety and Depression scale).
Time frame: 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))
Time frame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
Changes of Social support Score (The Medical Outcomes Study Social Support Survey).
Time frame: After Intervention (two months immediately post intervention)
Satisfaction Score (Satisfaction Score from a single item 6-point Ordinal Descriptive Scale).
Contact information is provided by the study sponsor or research team.
Bernard JG Chua, MBBS (Hons)(Aus), MRCP (UK)
CONTACT
Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed
CONTACT
National Cancer Centre, Singapore
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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