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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
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
Secondary ID [1] 289205 0
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 298760 0
Condition category
Condition code
Cancer 298811 298811 0 0
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] 294739 0
Treatment: Other
Intervention code [2] 294764 0
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] 298283 0
self-efficacy: Stanford Inventory of Cancer Patient Adjustment (SICPA)
Timepoint [1] 298283 0
T0: baseline, before randomisation
T1: immediately after intervention;
T2: 12 weeks after intervention.
Primary outcome [2] 298284 0
Social support: Multidimensional Scale of Perceived Social Support (MSPSS)
Timepoint [2] 298284 0
T0: baseline, before randomisation
T1: immediately after intervention;
T2: 12 weeks after intervention.
Secondary outcome [1] 323744 0
Symptom distress: M.D. Anderson Symptom Inventory (MDASI)
Timepoint [1] 323744 0
T0: baseline, before randomisation
T1: immediately after intervention;
T2: 12 weeks after intervention.
Secondary outcome [2] 323745 0
Quality of life: Functional Assessment of Cancer Treatment-B (FACT-B)
Timepoint [2] 323745 0
T0: baseline, before randomisation
T1: immediately after intervention;
T2: 12 weeks after intervention.
Secondary outcome [3] 323746 0
This is a composite secondary outcome
Anxiety and depression: Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 323746 0
T0: baseline, before randomisation
T1: immediately after intervention;
T2: 12 weeks after intervention.

Eligibility
Key inclusion criteria
(1) diagnosed with breast cancer within 3-8 weeks; (2) treated with curative intent surgery and adjuvant chemotherapy at the study sites; (3) able to access internet at home with computer or mobile phone; (4) cognitively and physically capable of participating and completing self-report questionnaire; (5) having a telephone and email address to contact for follow up; (6) able to speak and read Mandarin.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) having a concurrent major physical illness; (2) having a chronic mental health problem.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed. Slips will be put into one opaque envelopes, with pinks slips for randomly generated number, white slips for all other numbers. Women with breast cancer will be asked to pick a slip from the opaque envelopes. Based on the pink colour coded slip, women will be allocated into the experimental group; otherwise, in the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The Research Randomizer (2015) will be used to randomly generate a set of 53 unique, non-duplicating numbers from 1 to 106.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size determination
The primary outcome of self-efficacy is used to estimate effect size basing on power analysis (Cohen, 1992). Previous study on IIPs for women with breast cancer measured QoL, social support, and health competence and reported medium effect size (0.46), but the effect size of self-efficacy was not mentioned (Gustafson et al., 2008). Previous research on psychoeducation to enhance self-efficacy on Chinese patients with colorectal cancer (Zhang et al., 2014) demonstrated medium effect size of self-efficacy as 0.60. We estimated 20% attrition rate, based on the dropout rate of 10-15% in previous studies on internet-based interactive programs (Gustafson et al., 2008; Loiselle, Edgar, Batist, Lu, & Lauzier, 2010). To achieve a power of 0.80 at 0.05 level of significance, a minimum of 106 women (53 in each group) are required for this study.

Data analysis
All outcome measures will be analysed using IBM SPSS Statistics 21.0 (IBM Corp, 2013). Intention-to treat analysis will be adopted to manage missing data. The baseline differences between the interventional and control groups will be assessed with the Chi-square (?2) test for the binary demographic data and the independent sample t-test for continuous variable. Adjusted for the possible confounding factors of demographic variables, the repeated measures triply MANCOVA will be conducted to determine whether the BCS intervention is effective in improving self-efficacy, social support, QoL and reducing symptom distress, and anxiety and depression across three time points of data collection (Baseline, immediately and 12 weeks after intervention).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7875 0
China
State/province [1] 7875 0
Fujian Province and Hunan province

Funding & Sponsors
Funding source category [1] 293581 0
Government body
Name [1] 293581 0
National Natural Science foundation of China
Address [1] 293581 0
Shuangqin Road #83, Haiding District
Beijing, P.R.China
Post code:100085
Country [1] 293581 0
China
Primary sponsor type
University
Name
The University of Newcastle
Address
School of Nursing and Midwifery
Faculty of Health and Medicine
The University of Newcastle (UoN)
University Drive
Callaghan NSW 2308
Australia

Country
Australia
Secondary sponsor category [1] 292403 0
None
Name [1] 292403 0
Address [1] 292403 0
Country [1] 292403 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295028 0
Human Research Ethics Committee at the University of Newcastle
Ethics committee address [1] 295028 0
Research Services
Research Integrity Unit
NIER, Block C
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 295028 0
Australia
Date submitted for ethics approval [1] 295028 0
Approval date [1] 295028 0
09/05/2016
Ethics approval number [1] 295028 0
H-2015-0448

Summary
Brief summary
The major objectives of this Randomized Controlled Trial (RCT) is to evaluate the effectiveness of a BCS program (Mobile Application) in improving self-efficacy, social support, and QoL, reducing symptom distress, and decreasing anxiety and depression for Chinese women with breast cancer undergoing chemotherapy. It is hypothesized that when compared with the control group, women with breast cancer undergoing chemotherapy in the experimental group will have statistically significant:
1. improved self-efficacy, social support, QoL, as well as significantly reduced symptom distress, anxiety and depression (baseline, post-test 1, and post-test 2),
2. higher satisfaction level towards health care during chemotherapy.
Trial website
http://breastesupport.xmu.edu.cn/
Trial related presentations / publications
Public notes
N/A

Contacts
Principal investigator
Name 65822 0
Prof Sally Chan
Address 65822 0
RW1-39, Callaghan
School of Nursing and Midwifery
Faculty of Health and Medicine
The University of Newcastle
University Drive
Callaghan, NSW 2308
Australia
Country 65822 0
Australia
Phone 65822 0
+61 2 4921 7873
Fax 65822 0
+61 2 4921 6301
Email 65822 0
sally.chan@newcastle.edu.au
Contact person for public queries
Name 65823 0
Ms Jiemin Zhu
Address 65823 0
Room 208, Alice Lee Nursing Building
Nursing department, Medical College, Xiamen University,
Xiangan Nan Road
Xiangan District
Xiamen city, Fujian Province, P.R.China
Post Code: 361102
Country 65823 0
China
Phone 65823 0
+86 15960212649
Fax 65823 0
+86 592 2189613
Email 65823 0
jiemin.zhu@uon.edu.au
Contact person for scientific queries
Name 65824 0
Ms Jiemin Zhu
Address 65824 0
Room 208, Alice Lee Nursing Building
Nursing department, Medical College, Xiamen University,
Xiangan Nan Road
Xiangan District
Xiamen city, Fujian Province, P.R.China
Post Code: 361102
Country 65824 0
China
Phone 65824 0
+86 15960212649
Fax 65824 0
+86 592 2189613
Email 65824 0
jiemin.zhu@uon.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary