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NCT Number: NCT06977360

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

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.

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Key information

Age range

21 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre, Singapore

Singapore

Location status: Recruiting

Location contact

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

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine care

Other

Routine care provided by NCCS

Routine care + iCareBreast+ mobile app

Other

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

Primary outcomes

  1. 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.

  2. 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)

  3. 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).

  4. 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)

Secondary outcomes

  1. 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)

    Changes of anxiety and depression Score (Hospital Anxiety and Depression scale).

  2. 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)

    Changes of Cancer related quality of lief Score (Functional Assessment of Cancer Therapy-Breast (FACT-B))

  3. 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 Social support Score (The Medical Outcomes Study Social Support Survey).

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

    Time frame: After Intervention (two months immediately post intervention)

    Satisfaction Score (Satisfaction Score from a single item 6-point Ordinal Descriptive Scale).

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+65 64368000

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

CONTACT

[email protected]

+65 64368000

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Collaborators

  • Buddy Healthcare Ltd OY

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 18, 2025
Registry last updated
Sep 12, 2025

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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