An Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery

NCT04172350 | Unknown DMC

• 1 other identifier: 2019/2632
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop a mobile app-based periopeartive intervnetion for women undergoing breast cancer surgery and examine the effectiveness of the program on participants' health outcomes of self-efficacy, anxiety and depression, pain and fatigue, quality of life, and satisfaction with perioperative care. This study also aims to explore the perceptions of participants on strengths and weaknesses of using the app.

Conditions

Breast Cancer Female; Surgery

Keywords

women; breast cancer; surgery; perioperative care; self-efficacy; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Participant's self-efficacy

  Participant's self-efficacy level will be measured using the 10-item General Self-Efficacy (GSE) Scale. The total score for GSE is tabulated by the sum of all scores of each component. The scoring system ranges between 10 and 40. The higher the score achieved, the higher the level of self-efficacy (Schwarzer \& Jerusalem, 1995).

  Participant's self-efficacy will be assessed at baseline (about 2 weeks before surgery) and assessing changes between baseline and 2 weeks after surgery.

Secondary Outcomes (5)

• Participant's anxiety and depression

  Participant's anxiety and depression will be assessed at baseline (about 2 weeks before surgery) and assessing changes between baseline and 2 weeks after surgery.

• Participant's pain and fatigue

  Participant's pain and fatigue will be assessed at baseline (about 2 weeks before surgery) and assessing changes between baseline and 2 weeks after surgery.

• Participant's quality of life

  Participant's quality of life will be assessed at baseline (about 2 weeks before surgery) and assessing changes between baseline and 2 weeks after surgery.

• Satisfaction with perioperative care

  Participant's satisfaction with perioperative care will be assessed around 2 weeks after surgery.

• Process evaluation interview

  Semi-structured interviews will be conducted around 2 weeks after surgery.

Study Arms (2)

Intervention group: iCareBreast plus routine care

EXPERIMENTAL

Participants in the intervention group will receive the routine care provided by the hospital (the same as the control group) plus the iCareBreast mobile app, which provides i) pre-surgery education and instructions; ii) post-surgery education, instructions, and recovery plan; iii) positive psychological support; and iv) social support. The total intervention period is 29 days (14 days before surgery, operation day, and 14 days after the surgery).

Other: iCareBreast; Other: Routine care

Control group: Routine care

ACTIVE COMPARATOR

Participants in the control group will only receive routine care provided by the attending Hospital. Participants being allocated to the control group may freely use the Internet to search for information regarding breast cancer but will not be granted to access the iCareBreast app.

Other: Routine care

Interventions

iCareBreast OTHER

The iCareBreast BuddyCare mobile app is an interactive surgery preparation and recovery app for patients. It is a patient-centric care coordination and patient engagement mobile app that supports patients' perioperative journey. The app provides day-to-day information throughout the perioperative journey to patients from 2 weeks before surgery to 2 weeks after the surgery. Meanwhile the healthcare professional can monitor patients' use of the app. That is, the iCareBreast App provides patients with all the information about the surgery-related procedure and treatment via an efficient, user-friendly and interactive timeline. Patients will receive pop-up reminders daily for them to use the app. The objective of this app is to allow each patient to focus on caring for herself as a patient.

Intervention group: iCareBreast plus routine care

Routine care OTHER

Routine care provided by the hospital includes general information regarding pre-operation preparation and post-operative care (e.g. wound care, pain management and physiotherapy).

Control group: Routine care; Intervention group: iCareBreast plus routine care

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are the age of 21 years old and above at the point of recruitment;
• are diagnosed with breast cancer;
• will undergo breast cancer surgery (mastectomy or wide excision);
• can speak, read and write in English; and
• has access to smart phone.

You may not qualify if:

• been suffering from psychiatric illness or impaired cognitive function;
• alcohol or substance abuse within the previous year;
• anxiety disorder and other mood disorder as identified from their medical records; and
• been in the bereavement period in the last 6 months.

Sponsors & Collaborators

• HE Hong-Gu: lead
• KK Women's and Children's Hospital: collaborator
• Buddy Healthcare Ltd OY: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

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  RESULT

• Pang Y, He H, Ng RP, Lee NKL, Htein MMW, Zhao XX, Li YH, Chan EJ, Zhu L, Liu GY, Pikkarainen M, Lim SH. Effectiveness of an Innovative Mobile-Based Perioperative Care Program for Women Undergoing Breast Cancer Surgery (iCareBreast): Randomized Controlled Trial. J Med Internet Res. 2025 Apr 21;27:e71684. doi: 10.2196/71684.

  PMID: 40258266 DERIVED

Related Links

• Cancer Statistics
• Khalik, S. (2017, June 20). Breast, prostate cancers rising sharply in Singapore.
• National Cancer Centre Singapore. (2017). Obesity and Breast Cancer.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hong-Gu HE, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong-Gu HE, PhD

CONTACT

+6565167448; nurhhg@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal investigator will generate the randomisation number and randomisation sequences according to the block randomisation method. The randomly generated sequences would be used for recruitment of the participants, who will be assigned in successive order according to the sequence. Opaque and sealed envelopes containing slips of paper indicate the randomly allocated group. One research assistant will recruit participants and conduct randomisation and another research assistant who is blind from the group allocation will collect post-test data. Through these carefully deliberated processes, randomization and allocation concealment will be ensured.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: A two-group pre- and post-test randomized controlled trial will be conducted. A total of 112 eligible women who are diagnosed with breast cancer and are required for breast surgery will be recruited from the Breast Department in a public tertiary hospital in Singapore. Participants will be randomly allocated to either the intervention group (receiving routine care provided by the hospital plus iCareBreast) or the control group (only receiving routine care provided by the hospital) using a block randomisation.

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: November 19, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2021
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)