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

NCT06977360 | Recruiting

• 1 other identifier: iCareBreast+
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.To develop a new iteration of an innovative smartphone-based self-care solution for patients with breast cancer undergoing chemotherapy (iCareBreast+);
2. 2.To assess the feasibility and acceptability of iCareBreast+; and
3. 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

Breast Cancer

Keywords

Breast Cancer; Digital Health; mHealth; Mobile health; Psychosocial; Randomized Controlled Trial; Self-efficacy; Chemotherapy

Outcome Measures

Primary Outcomes (4)

• The feasibility of research method and Intervention

  Participants recruitment and attrition rates.

  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)

  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).

  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)

  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

  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

  Baseline (on enrolment day), and after Intervention (two months immediately post intervention)

• The impact of psychosocial Intervention (iCareBreast+ app) on cancer self-efficacy

  Baseline (on enrolment day), and after Intervention (two months immediately post intervention)

• The impact of psychosocial Intervention (iCareBreast+ app) on satisfaction of oncological care

  After Intervention (two months immediately post intervention)

Study Arms (2)

Control Group

EXPERIMENTAL

Other: Routine care

Intervention Group

EXPERIMENTAL

Other: Routine care + iCareBreast+ mobile app

Interventions

Routine care OTHER

Routine care provided by NCCS

Control Group

Routine care + iCareBreast+ mobile app OTHER

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

Intervention Group

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Buddy Healthcare Ltd OY: collaborator

Study Sites (1)

National Cancer Centre, Singapore

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

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

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+65 64368000; ryan.shea.tan.y.c@singhealth.com.sg

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

CONTACT

+65 64368000; bernard.chua.j.g@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 18, 2025
• Study Start: May 23, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)