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Recruiting 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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Routine care, Routine care + iCareBreast+ mobile app.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 21 years — 100 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

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

Primary outcome measures

  • 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 acceptability of intervention [Time frame: 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 knowledge of breast cancer treatment [Time frame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)]
Secondary outcome measures (4)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Singapore · 1 center
  • National Cancer Centre, Singapore — Singapore

Identifiers

NCT: NCT06977360 · iCareBreast+

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗