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

November 21, 2019 updated by: HE Hong-Gu

Developing and Examining Preliminary Effects of An Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery (iCareBreast): A Pilot Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Other: 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.
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).
Active Comparator: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant's self-efficacy
Time Frame: Participant's self-efficacy will be assessed at baseline (about 2 weeks before surgery) and assessing changes between baseline and 2 weeks after surgery.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant's anxiety and depression
Time Frame: 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 anxiety and depression levels will be measured using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items: 7 items measuring depression and the other 7 items measuring anxiety. The response ranges from 0 (no problem) to 3 (high level of problem). The total score ranged from 0 to 21 with the higher score indicating more anxiety or 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
Time Frame: 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.
Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) will be used to measure participant's pain and fatigue level in this study. The MFSI-SF consists of 30 items. Respondents indicate the extent to which they have experienced each symptom during the preceding one-week period (0 = not at all; 4 = extremely). Ratings are summed to obtain scores for 5 subscales (general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor) with the higher score indicating worse symptom.
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
Time Frame: 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.
Participant's quality of life will be measured by the European Organization for Research and Treatment-QOL questionnaire and breast cancer specific module (EORTC QLQ-BR23). The format uses Likert scales, with scoring from 1 ('not at all') to 4 ('very much'). The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss. The scoring of the EORTC QLQ-BR23 was performed according to the EORTC scoring manual. All scores were linearly transformed to a 0 to 100 scale with a higher functional score representing a more healthy level of functioning, while a higher symptom score represents a worse symptom/problem.
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
Time Frame: Participant's satisfaction with perioperative care will be assessed around 2 weeks after surgery.
A 6-point Ordinal Descriptive Scale (ODS) for assessing patients' satisfaction with perioperative care from 1 (very dissatisfied) to 6 (very satisfied) will be used to assess patients' self-reported level of satisfaction with perioperative care they received.
Participant's satisfaction with perioperative care will be assessed around 2 weeks after surgery.
Process evaluation interview
Time Frame: Semi-structured interviews will be conducted around 2 weeks after surgery.
A semi-structured interview guide will be used to interview about 15 participants from the intervention group for their opinion on the strengths, weaknesses of the iCareBreast, as well as their suggestions for improvement.
Semi-structured interviews will be conducted around 2 weeks after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HE Hong-Gu

Collaborators

KK Women's and Children's Hospital
Buddy Healthcare Ltd OY

Investigators

  • Principal Investigator: Hong-Gu HE, PhD, National University, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2019

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

November 19, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/2632

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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