ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000639426

Ethics application status

Approved

Date submitted

12/05/2016

Date registered

17/05/2016

Date last updated

21/04/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Breast Cancer e-Support Program (Mobile Application) to improve symptom management, self-efficacy, social support, Quality of Life, anxiety and depression for Chinese Women with Breast Cancer Undergoing Chemotherapy

Scientific title

Secondary ID [1]

Funding body: Natural Science Foundation of China,
Number: 71503219

Universal Trial Number (UTN)

U1111-1182-8350

Trial acronym

BCS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

breast cancer

Condition category

Condition code

Cancer

Breast

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Breast Cancer e-Support (BCS) program is a mobile application program. The participants in the intervention group need to scan the two-dimension code in the website of http://breastesupport.xmu.edu.cn/ and download the APP. It has a fixed structure that cover four cycles of chemotherapy, which is about 12 weeks. Bandura’s self-efficacy theory and the social exchange theory were used to guide the development of BCS. BCS has four modules: 1) Learning centre; 2) Discussion forum; 3) Ask-The-Expert; 4) Personal stories. These four modules are visually recognizable on the homepage of BCS. It is up to women how often and how long they make use of the intervention.

In the Learning centre part, 12 topics related to symptom management and library will be provided in this part. 12 topics with learning materials will include: 1) nausea and vomit management; 2) improving diet by making healthier food choice; 3) choosing appropriate exercise; 4) stress management via relaxation training; 5) weight management; 6) how to deal with body changes; 7) fatigue management; 8) sleep management; 9) alopecia management; 10) improving communication with health care providers; 11) processing and communicating emotional experiences to people inside of one’s existing network; and 12) How to deal with negative emotions. To create the 12 topics, detailed discussion with multidisciplinary Chinese oncology professionals were carried out. Women will be encouraged to go through a topic and practice the corresponding strategies each week. All the learning materials are geared towards skills building on symptom self-management. The library will provide basic information about symptoms, diagnosis, stages, treatment options, community support service, and answers to frequently asked questions. There will also be links to reliable cancer websites.

The discussion forum is where social networking occurs. Women will be encouraged to provide feedback and encouragement to each other. They will be invited to discuss the topics in the learning material. The discussion will be moderated by a qualified healthcare professional. She will provide encouragement and suggestions to women regarding their progress on symptom management. Women will be encouraged to post message to the discussion forum any time. They can ask questions and discuss topics with a safe environment. They can share information and experience, ask questions, offer insight into their own personal situations, and share hopes and fears.

The Ask-The-Expert service provides women with the opportunity to anonymously ask health related questions by email at any time. Healthcare professionals (one doctor and one head nurse in the studying hospitals) will provide response to the question within 48 hours. Only the health care professionals and senders have access to the questions and the responses.

In the personal stories part, Five recorded interviews with women who completed chemotherapy after breast cancer diagnosis and surgery will be available in this part. Women who have different breast cancer stage, ages, and socio-economic status will be interviewed and recorded in these videos to provide role model for women with different background. women will be encouraged to post their feedback and share their feelings after watching the videos.

All the modules aim to enhance women’s self-efficacy, social support, and symptom management. Mastery experiences include the discussion of symptom management related to chemotherapy in the learning centre. Vicarious experiences involve reading others’ personal stories and share their own stories. Verbal persuasion includes feedback and verbal cues from peers and healthcare professionals in the Discussion forum and Ask-The-Expert. Arousal state includes the learning materials and sharing experience that expect symptom which might occur during chemotherapy and the management strategies. In addition, Discussion forum and Ask-The-Expert are designed to build women’s social network, thus women can obtain structural support and functional support from peer and healthcare professionals.

Fidelity of the intervention
It is important to maintain the fidelity of the intervention to enhance the internal and external validity of the program. Different strategies will be used to enhance the fidelity of BCS such as maintain the consistency in the delivery of the intervention and monitoring and reinforcing women’s compliance with the intervention.

To maintain the consistency in the delivery of the intervention, the same researcher (ZJM) will organize the topics, give feedback and verbal cues in the Discussion forum in the program. The moderator (ZJM) will also moderate the online forum by reading all messages each day, facilitating online discussion, providing expert information when requested, and intervening appropriately if message posted is inappropriate or hostile. The researcher is a PhD nursing student who is familiar with the knowledge of breast cancer and chemotherapy. To encourage women to comply with the intervention, the benefits of BCS such as their questions being answered by healthcare professionals within 48 hours will be emphasized to women.

To assess the intervention adherence, the website contains tracking system. The researchers could monitor who access to BCS, how often, the modules that they access in and how long they spend their time in each module. The internet usage data such as frequency and duration of logins, website activity of each module of BCS will be recorded and evaluated

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Women in the control groups will receive routine care provided by the hospital. The routine care involves support by nurses and doctors while they stay for two days in the hospital during each cycle of chemotherapy. As usual, the nurse will provide information on chemotherapy and side effects before women start treatment. There are currently no BCS for education and social support provided by healthcare services in the studying sites. The control group may freely use internet to search information about breast cancer. They do not have access to the BCS intervention which need authorization from the main investigator to log in the APP.

Control group

Active

Outcomes

Primary outcome [1]

self-efficacy: Stanford Inventory of Cancer Patient Adjustment (SICPA)

Timepoint [1]