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

Surgery Clinical Trial

— iCareBreast  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04172350
• Other study ID #: 2019/2632
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2019
• Source: National University, Singapore
• Contact: Hong-Gu HE, PhD
• Phone: +6565167448
• Email: nurhhg[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Surgery

Intervention

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.
• 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).

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
HE Hong-Gu	Buddy Healthcare Ltd OY, KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

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* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant's anxiety and depression	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.
Secondary	Participant's pain and fatigue	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.
Secondary	Participant's quality of life	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.
Secondary	Satisfaction with perioperative care	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.
Secondary	Process evaluation interview	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.

External Links

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