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, Singapore40 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The feasibility of research method and Intervention

Participants recruitment and attrition rates.

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

Process evaluation (semi-structured interview) and app quality (mobile app rating scale score)

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

The impact of psychosocial intervention (iCareBreast+ app) on cancer self-efficacy

Changes of Self-efficacy Score (Self-efficacy Score from the cancer Behaviour Inventory-Brief (CBI-B) survey).