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

ConditionBreast Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age21-100

SponsorNational Cancer Centre, Singapore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Control GroupExperimental treatment 1 intervention

Group B: Intervention GroupExperimental treatment 1 intervention

Trial 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).

Time frame