Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Digital Health
mHealth
Mobile health
Psychosocial
Randomized Controlled Trial
Self-efficacy
Chemotherapy
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Buddy Healthcare Ltd OY
First posted: 2025-05-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.

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.

Primary outcomes:
measure: The feasibility of research method and Intervention
timeFrame: Throughout data collection period, estimated up to six months or until last subject with last visit completion whichever is later.
measure: The acceptability of intervention
timeFrame: After intervention (two months immediately post intervention)
measure: The impact of psychosocial intervention (iCareBreast+ app) on cancer self-efficacy
timeFrame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
measure: The impact of psychosocial Intervention (iCareBreast+ app) on knowledge of breast cancer treatment
timeFrame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
Secondary outcomes:
measure: The impact of psychosocial Intervention (iCareBreast+ app) on anxiety and depression
timeFrame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
measure: The impact of psychosocial Intervention (iCareBreast+ app) on cancer related quality of life
timeFrame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
measure: The impact of psychosocial Intervention (iCareBreast+ app) on cancer self-efficacy
timeFrame: Baseline (on enrolment day), and after Intervention (two months immediately post intervention)
measure: The impact of psychosocial Intervention (iCareBreast+ app) on satisfaction of oncological care
timeFrame: After Intervention (two months immediately post intervention)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre, Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Dr Ryan Shea YC Tan, MBBS, MRCP(UK), MMed
role: PRINCIPAL_INVESTIGATOR
References: