Breast CancerNCT06977360
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
A study testing Routine care and Routine care + iCareBreast+ mobile app in people with Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Routine care and Routine care + iCareBreast+ mobile app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 23 May 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre, Singapore
Singapore
Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed
About this study
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:
- To develop a new iteration of an innovative smartphone-based self-care solution for patients with breast cancer undergoing chemotherapy (iCareBreast+);
- To assess the feasibility and acceptability of iCareBreast+; and
- 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.
Read the 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
- Being tested
- Routine care, Routine care + iCareBreast+ mobile app
- Keywords
- Breast Cancer, Digital Health, mHealth, Mobile health, Psychosocial, Randomized Controlled Trial, Self-efficacy, Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
Routine care provided by NCCS
Routine care + iCareBreast+ mobile appOther
Routine care provided by NCCS (identical to the control group) along with access to the iCareBreast+ mobile app
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Not described Receives: Other: Routine care |
| Intervention Group | Experimental | Not described Receives: Other: Routine care + iCareBreast+ mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of research method and Intervention
Participants recruitment and attrition rates.
Measured: Throughout data collection period, estimated up to six months or until last subject with last visit completion whichever is later.
The acceptability of intervention
Process evaluation (semi-structured interview) and app quality (mobile app rating scale score)
Measured: After intervention (two months immediately post intervention)
The impact of psychosocial intervention (iCareBreast+ app) on cancer self-efficacy
Changes of Self-efficacy Score (Self-efficacy Score from the cancer Behaviour Inventory-Brief (CBI-B) survey).
Measured: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on knowledge of breast cancer treatment
Changes of knowledge Score (Knowledge Score from a scale of 0-10)
Measured: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
Secondary outcomes (4)
The impact of psychosocial Intervention (iCareBreast+ app) on anxiety and depression
Changes of anxiety and depression Score (Hospital Anxiety and Depression scale).
Measured: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on cancer related quality of life
Changes of Cancer related quality of lief Score (Functional Assessment of Cancer Therapy-Breast (FACT-B))
Measured: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on cancer self-efficacy
Changes of Social support Score (The Medical Outcomes Study Social Support Survey).
Measured: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on satisfaction of oncological care
Satisfaction Score (Satisfaction Score from a single item 6-point Ordinal Descriptive Scale).
Measured: After Intervention (two months immediately post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start23 May 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Buddy Healthcare Ltd OY
- Responsible party
- Sponsor
- Investigators
- Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977360
- Sponsor's protocol ID
- iCareBreast+
- Status last verified
- Sep 2025
- First submitted
- 9 May 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06977360
- Acronym / sponsor ID
- iCareBreast+
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Digital Health, mHealth, Mobile health, Psychosocial, Randomized Controlled Trial, Self-efficacy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Buddy Healthcare Ltd OY
- Study start
- 23 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To develop a new iteration of an innovative smartphone-based self-care solution for patients with breast cancer undergoing chemotherapy (iCareBreast+);
- To assess the feasibility and acceptability of iCareBreast+; and
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Other: Routine care |
| Intervention Group | Experimental | Other: Routine care + iCareBreast+ mobile app |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine careRoutine care provided by NCCS | Other | Control Group |
| Routine care + iCareBreast+ mobile appRoutine care provided by NCCS (identical to the control group) along with access to the iCareBreast+ mobile app | Other | Intervention Group |
Primary outcome
The feasibility of research method and Intervention
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.
The acceptability of intervention
Time frame: After intervention (two months immediately post intervention)
Process evaluation (semi-structured interview) and app quality (mobile app rating scale score)
The impact of psychosocial intervention (iCareBreast+ app) on cancer self-efficacy
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).
The impact of psychosocial Intervention (iCareBreast+ app) on knowledge of breast cancer treatment
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)
4 secondary outcomes
The impact of psychosocial Intervention (iCareBreast+ app) on anxiety and depression
Time frame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on cancer related quality of life
Time frame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on cancer self-efficacy
Time frame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
The impact of psychosocial Intervention (iCareBreast+ app) on satisfaction of oncological care
Time frame: After Intervention (two months immediately post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine care and Routine care + iCareBreast+ mobile app in people with Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed (+65 64368000, ryan.shea.tan.y.c@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of research method and Intervention (time frame: Throughout data collection period, estimated up to six months or until last subject with last visit completion whichever is later.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.