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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

ClinicalTrials.gov IDNCT06977360

PhaseNA

Enrollment40

SponsorNational Cancer Centre, Singapore

Age21 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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.

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 outcomes

The feasibility of research method and Intervention (Throughout data collection period, estimated up to six months or until last subject with last visit completion whichever is later.)
The acceptability of intervention (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 knowledge of breast cancer treatment (Baseline (on enrolment day), and after Intervention (two months immediately post intervention))

Eligibility information

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.

Study locations

National Cancer Centre, Singapore, Singapore, Singapore

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.