Clinical trial NCT04172350: An Innovative Care-improvement Smartphone-based Perioperative Solution for Women Undergoing Breast Cancer Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Female
Surgery
Keywords: women
breast cancer
surgery
perioperative care
self-efficacy
randomised controlled trial
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: KK Women's and Children's Hospital
name: Buddy Healthcare Ltd OY
First posted: 2019-11-21
Enrollment: 112
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participant's self-efficacy
timeFrame: 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:
measure: Participant's anxiety and depression
timeFrame: 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.
measure: Participant's pain and fatigue
timeFrame: 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.
measure: Participant's quality of life
timeFrame: 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.
measure: Satisfaction with perioperative care
timeFrame: Participant's satisfaction with perioperative care will be assessed around 2 weeks after surgery.
measure: Process evaluation interview
timeFrame: Semi-structured interviews will be conducted around 2 weeks after surgery.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: National University of Singapore
name: Hong-Gu HE, PhD
role: PRINCIPAL_INVESTIGATOR
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