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

NCT ID: NCT06977360

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-23

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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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

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

Group Type EXPERIMENTAL

Routine care

Intervention Type OTHER

Routine care provided by NCCS

Intervention Group

Group Type EXPERIMENTAL

Routine care + iCareBreast+ mobile app

Intervention Type OTHER

Routine care provided by NCCS (identical to the control group) along with access to the iCareBreast+ mobile app

Interventions

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Routine care

Routine care provided by NCCS

Intervention Type OTHER

Routine care + iCareBreast+ mobile app

Routine care provided by NCCS (identical to the control group) along with access to the iCareBreast+ mobile app

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Buddy Healthcare Ltd OY

UNKNOWN

Sponsor Role collaborator

National Cancer Centre, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

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National Cancer Centre, Singapore

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed

Role: CONTACT

+65 64368000

Bernard JG Chua, MBBS (Hons)(Aus), MRCP (UK)

Role: CONTACT

+65 64368000

Facility Contacts

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Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed

Role: primary

Other Identifiers

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iCareBreast+

Identifier Type: -

Identifier Source: org_study_id

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