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Breast Cancer FemaleiCareBreastNCT04172350

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

A study testing iCareBreast and Routine care in people with Breast Cancer Female and Surgery, run by HE Hong-Gu at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older, women only
Conditions the study is for
Breast Cancer Female, Surgery
What is being tested?
iCareBreast and Routine care
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteSingapore
Study dates
19 Nov 2019to 31 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong-Gu HE, PhD contact

+6565167448

nurhhg@nus.edu.sg

Singapore1 site, 1 recruiting

  • KK Women's and Children's Hospital

    Singapore, 229899

    Hong-Gu He, PhD, +6565167448, nurhhg@nus.edu.sg

    Swee Ho, PhD, +6563945815, lim.swee.ho@singhealth.com.sg

    Recruiting

Other trials in Singapore

About this study

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

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.

Read the 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.

Being tested
iCareBreast, Routine care
Keywords
women, breast cancer, surgery, perioperative care, self-efficacy, randomised controlled trial
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iCareBreastOther

    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 careOther

    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).

Study groups in NCT04172350
Study groupRoleWhat they receive
Intervention group: iCareBreast plus routine careExperimentalParticipants 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).
Receives: Other: iCareBreast; Other: Routine care
Control group: Routine careActive comparatorParticipants 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.
Receives: Other: Routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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 (5)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: Participant's satisfaction with perioperative care will be assessed around 2 weeks after surgery.

  5. 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.

    Measured: Semi-structured interviews will be conducted around 2 weeks after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start19 Nov 2019
  3. Primary completion31 Oct 2020 (estimated)
  4. Study completion31 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04172350
Sponsor's protocol ID
2019/2632
Acronym
iCareBreast
Status last verified
Nov 2019
First submitted
19 Nov 2019
Last updated
25 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andreu Vaillo Y, Murgui Perez S, Martinez Lopez P, Romero Retes R. Mini-Mental Adjustment to Cancer Scale: Construct validation in Spanish breast cancer patients. J Psychosom Res. 2018 Nov;114:38-44. doi: 10.1016/j.jpsychores.2018.09.004. Epub 2018 Sep 15.

    PubMed 30314577

  • Beck KR, Tan SM, Lum SS, Lim LE, Krishna LK. Validation of the emotion thermometers and hospital anxiety and depression scales in Singapore: Screening cancer patients for distress, anxiety and depression. Asia Pac J Clin Oncol. 2016 Jun;12(2):e241-9. doi: 10.1111/ajco.12180. Epub 2014 Mar 27.

    PubMed 24673756

  • Bener A, Alsulaiman R, Doodson L, El Ayoubi HR. An assessment of reliability and validity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 among breast cancer patients in Qatar. J Family Med Prim Care. 2017 Oct-Dec;6(4):824-831. doi: 10.4103/jfmpc.jfmpc_17_17.

    PubMed 29564271

  • Boesen EH, Karlsen R, Christensen J, Paaschburg B, Nielsen D, Bloch IS, Christiansen B, Jacobsen K, Johansen C. Psychosocial group intervention for patients with primary breast cancer: a randomised trial. Eur J Cancer. 2011 Jun;47(9):1363-72. doi: 10.1016/j.ejca.2011.01.002. Epub 2011 Mar 31.

    PubMed 21458989

  • Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007 Aug;42(4):1758-72. doi: 10.1111/j.1475-6773.2006.00684.x.

    PubMed 17286625

  • Brady L. My Journey With Triple Negative Breast Cancer. Plast Surg Nurs. 2015 Jul-Sep;35(3):137-44. doi: 10.1097/PSN.0000000000000107. No abstract available.

    PubMed 26313679

  • Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101.

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Braybrooke JP, Mimoun S, Zarca D, Elia D, Pinder B, Lloyd AJ, Breheny K, Lomazzi M, Borisch B. Patients' experiences following breast cancer treatment: an exploratory survey of personal and work experiences of breast cancer patients from three European countries. Eur J Cancer Care (Engl). 2015 Sep;24(5):650-61. doi: 10.1111/ecc.12222. Epub 2014 Jul 23.

    PubMed 25053521

  • Broglio K. Randomization in Clinical Trials: Permuted Blocks and Stratification. JAMA. 2018 Jun 5;319(21):2223-2224. doi: 10.1001/jama.2018.6360. No abstract available.

    PubMed 29872845

  • Chan A, Lew C, Wang XJ, Ng T, Chae JW, Yeo HL, Shwe M, Gan YX. Psychometric properties and measurement equivalence of the Multidimensional Fatigue Syndrome Inventory- Short Form (MFSI-SF) amongst breast cancer and lymphoma patients in Singapore. Health Qual Life Outcomes. 2018 Jan 19;16(1):20. doi: 10.1186/s12955-018-0846-6.

    PubMed 29351803

  • Chaoul A, Milbury K, Spelman A, Basen-Engquist K, Hall MH, Wei Q, Shih YT, Arun B, Valero V, Perkins GH, Babiera GV, Wangyal T, Engle R, Harrison CA, Li Y, Cohen L. Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy. Cancer. 2018 Jan 1;124(1):36-45. doi: 10.1002/cncr.30938. Epub 2017 Sep 20.

    PubMed 28940301

  • Chenail, R. J. (2011). How to conduct clinical qualitative research on the patient's experience. Qualitative Report, 16(4), 1173-1190.

  • Cobo-Cuenca AI, Martin-Espinosa NM, Rodriguez-Borrego MA, Carmona-Torres JM. Determinants of satisfaction with life and self-esteem in women with breast cancer. Qual Life Res. 2019 Feb;28(2):379-387. doi: 10.1007/s11136-018-2017-y. Epub 2018 Oct 15.

    PubMed 30324585

  • Coyne IT. Sampling in qualitative research. Purposeful and theoretical sampling; merging or clear boundaries? J Adv Nurs. 1997 Sep;26(3):623-30. doi: 10.1046/j.1365-2648.1997.t01-25-00999.x.

    PubMed 9378886

Questions about this trial

What is this clinical trial studying?

A study testing iCareBreast and Routine care in people with Breast Cancer Female and Surgery, run by HE Hong-Gu at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hong-Gu HE, PhD (+6565167448, nurhhg@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04172350, which also lists 69 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.

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