An Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery
NCT ID: NCT04172350
Last Updated: 2019-11-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
112 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-11-19
Study Completion Date
2021-10-31
Brief Summary
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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.
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Detailed Description
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Background: Breast cancer is the most common cancer in women worldwide and Singapore. In addition to the disease itself, undergoing surgery is also a stressful event for patients. Many of them have physical and psychosocial challenges. A variety of psychosocial interventions have been developed to improve patients'/survivors' health outcomes with some intervention using mobile technology. However, there is no any smart-phone based solution that have developed a comprehensive perioperative solution for this group of patients.
Aim: This study aims to (1) develop an Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery (iCareBreast); (2) examine the effectiveness of the iCareBreast on participants' health outcomes of self-efficacy (primary outcome), anxiety and depression, pain and fatigue, quality of life, and satisfaction with perioperative care; and (3) explore the perceptions of participants on strengths and weaknesses of iCareBreast.
Research Questions:
* Do the participants receiving routine care plus the iCareBreast report higher level of self-efficacy when compared to those receiving routine care alone?
* Do the participants receiving routine care plus the iCareBreast report lower levels of anxiety and depression when compared to those receiving routine care alone?
* Do the participants receiving routine care plus the iCareBreast report lower levels of postoperative pain and fatigue when compared to those in the control group?
* Do the participants receiving routine care plus the iCareBreast report higher level of quality of life when compared to those receiving routine care alone?
* Do the participants receiving routine care plus the iCareBreast report higher level of satisfaction with perioperative care when compared to those receiving routine care alone?
* What are the perceptions of participants on strengths and weaknesses of iCareBreast?
Hypothesis As compared to the participants in the control group, those in the intervention group who receive routine care plus the iCareBreast will report a
* higher level of self-efficacy,
* lower levels of anxiety and depression,
* lower levels of pain and fatigue,
* higher level of quality of life, and
* higher level of satisfaction with perioperative care.
Methods: 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). Outcomes of self-efficacy, anxiety and depression, pain and fatigue, quality of life, and satisfaction with perioperative care will be measured by relevant valid and reliable instruments at two time-points (baseline and post-test). Around 15 participants in the intervention group will be invited to participate in semi-structured interviews to explore their opinions on the iCareBreast. Quantitative data will be analyzed by SPSS and qualitative data will be analyzed by using content analysis.
Significance of the study: This study will develop the iCareBreast, which will provide a platform for women undergoing breast cancer surgery to receive education about the disease, physical, psychological and social support as well as to enable interactions between health care workers and patients. This study will generate the preliminary effects of the iCareBreast to improve the aforementioned health outcomes of participants, which will be used to guide the change of future clinical practice to improve patient care. Mobile health holds promise as a low-cost communication tool for enhancing patient engagement and allowing healthcare providers to monitor recovery progress. This study will also inform the need for further studies for the implementation of similar solution for patients with other surgical needs.
Aim: This study aims to (1) develop an Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery (iCareBreast); (2) examine the effectiveness of the iCareBreast on participants' health outcomes of self-efficacy (primary outcome), anxiety and depression, pain and fatigue, quality of life, and satisfaction with perioperative care; and (3) explore the perceptions of participants on strengths and weaknesses of iCareBreast.
Research Questions:
* Do the participants receiving routine care plus the iCareBreast report higher level of self-efficacy when compared to those receiving routine care alone?
* Do the participants receiving routine care plus the iCareBreast report lower levels of anxiety and depression when compared to those receiving routine care alone?
* Do the participants receiving routine care plus the iCareBreast report lower levels of postoperative pain and fatigue when compared to those in the control group?
* Do the participants receiving routine care plus the iCareBreast report higher level of quality of life when compared to those receiving routine care alone?
* Do the participants receiving routine care plus the iCareBreast report higher level of satisfaction with perioperative care when compared to those receiving routine care alone?
* What are the perceptions of participants on strengths and weaknesses of iCareBreast?
Hypothesis As compared to the participants in the control group, those in the intervention group who receive routine care plus the iCareBreast will report a
* higher level of self-efficacy,
* lower levels of anxiety and depression,
* lower levels of pain and fatigue,
* higher level of quality of life, and
* higher level of satisfaction with perioperative care.
Methods: 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). Outcomes of self-efficacy, anxiety and depression, pain and fatigue, quality of life, and satisfaction with perioperative care will be measured by relevant valid and reliable instruments at two time-points (baseline and post-test). Around 15 participants in the intervention group will be invited to participate in semi-structured interviews to explore their opinions on the iCareBreast. Quantitative data will be analyzed by SPSS and qualitative data will be analyzed by using content analysis.
Significance of the study: This study will develop the iCareBreast, which will provide a platform for women undergoing breast cancer surgery to receive education about the disease, physical, psychological and social support as well as to enable interactions between health care workers and patients. This study will generate the preliminary effects of the iCareBreast to improve the aforementioned health outcomes of participants, which will be used to guide the change of future clinical practice to improve patient care. Mobile health holds promise as a low-cost communication tool for enhancing patient engagement and allowing healthcare providers to monitor recovery progress. This study will also inform the need for further studies for the implementation of similar solution for patients with other surgical needs.
Conditions
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Breast Cancer Female
Surgery
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
SINGLE
Outcome Assessors
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.
Study Groups
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Intervention group: iCareBreast plus routine care
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).
Group Type
EXPERIMENTAL
iCareBreast
Intervention Type
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.
Routine care
Intervention Type
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
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.
Group Type
ACTIVE_COMPARATOR
Routine care
Intervention Type
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).
Interventions
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iCareBreast
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 Type
OTHER
Routine care
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).
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
Minimum Eligible Age
21 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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KK Women's and Children's Hospital
OTHER_GOV
Sponsor Role
collaborator
Buddy Healthcare Ltd OY
UNKNOWN
Sponsor Role
collaborator
HE Hong-Gu
OTHER
Sponsor Role
lead
Responsible Party
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HE Hong-Gu
Associate Professor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Hong-Gu HE, PhD
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore
Locations
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KK Women's and Children's Hospital
Singapore, , Singapore
Site Status
RECRUITING
Countries
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Singapore
Central Contacts
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Facility Contacts
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References
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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.
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DERIVED
Related Links
Access external resources that provide additional context or updates about the study.
https://www.nccs.com.sg/patient-care/cancer-types/cancer-statistics
Cancer Statistics
https://www.straitstimes.com/singapore/health/breast-prostate-cancers-rising-sharply-in-spore
Khalik, S. (2017, June 20). Breast, prostate cancers rising sharply in Singapore.
https://www.nccs.com.sg/news/medical-news-singhealth/obesity-and-breast-cancer
National Cancer Centre Singapore. (2017). Obesity and Breast Cancer.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019/2632
Identifier Type: -
Identifier Source: org_study_id
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