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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Participant's self-efficacy
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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).
Intervention: iCareBreast (Other)
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).
Intervention: Routine care (Other)
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.
Intervention: Routine care (Other)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- 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.)
- Process evaluation interview(Semi-structured interviews will be conducted around 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.)
Investigators
HE Hong-Gu
Associate Professor
National University of Singapore