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

National Cancer Centre, Singapore

Status

Enrolling

Conditions

Breast Cancer

Treatments

Other: Routine care + iCareBreast+ mobile app

Other: Routine care

Study type

Interventional

Funder types

Other

Identifiers

NCT06977360

iCareBreast+

Details and patient eligibility

About

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:

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

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

21 to 100 years old

Volunteers

No Healthy Volunteers

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.