The DIALOGUE Study: Using Digital Health to Improve Care for Families With Predisposition to Hereditary Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 16
- 主要终点
- Change in proportion of informed relatives
研究概览
简要总结
In Hereditary Breast and Ovarian Cancer (HBOC) communication of genetic test results with relatives is essential to cascade testing. According to privacy laws those identified with the pathogenic variant have the sole responsibility to share information about test results and implications to relatives. Up to 50% of biological relatives are unaware of relevant genetic information, suggesting that benefits of genetic testing are not communicated effectively. Interventions designed to help mutation carriers communicate with relatives are critical for cascade genetic testing. Technology could play a significant role in facilitating communication and genetic education within HBOC families The investigators will develop a digital health platform for Swiss and Korean HBOC families. The digital platform will be based on the Family Gene Toolkit (FGT), a web-based intervention designed to enhance communication of genetic test results within HBOC families that has been tested for acceptability, usability, and participant satisfaction. The investigators will expand a Swiss research infrastructure to enable future collaborative projects between the two countries.
Specific Aims
- Develop a digital health platform to support the communication of cancer predisposition in HBOC families, based on linguistic and cultural adaptation methods of the FGT for the Swiss and Korean population
- Develop the K-CASCADE research infrastructure in Korea by expanding the research infrastructure developed by the CASCADE Consortium in Switzerland
- Evaluate the efficacy of the digital platform on psychological distress and communication of genetic test results, and knowledge of cancer genetics, coping, and decision making
- Explore the reach, effectiveness, adoption, implementation, and maintenance of the digital platform The digital platform will be based on the FGT with linguistic adaptation for web and mobile access. Aim 1 will be achieved with focus groups with 20-24 HBOC mutation carriers and relatives and 6-10 providers involved in genetic services. For Aim 2, a Korean database of HBOC families (K-CASCADE) will be based on the Swiss CASCADE database. For Aim 3, feasibility and efficacy of the digital solution against the comparison intervention will be assessed in a randomized trial with a sample of 104 HBOC mutation carriers (52 in each arm). Aim 4 will be achieved with survey and interview data collected from HBOC families and healthcare providers during all phases of the study.
详细描述
The study will adapt and evaluate a digital platform to support communication of genetic test results in HBOC families. The Family Gene Toolkit (FGT) will be adapted to be less resource intensive and disseminated to a larger audience without increasing costs. The study will also develop the K-CASCADE research infrastructure in order to measure the long-term outcomes of the embedded randomized trial.
Methods
Aim 1: Develop a digital platform to support the communication of cancer predisposition among HBOC families, based on linguistic and cultural adaptation of the FGT for the Swiss and Korean population.
FGT included four modules designed to increase knowledge of cancer genetics (Module 1); provide decisional support for genetic testing (Module 2); increase active coping to common challenges faced by HBOC families (Module 3); provide a five-steps, skills-building communication training (Module 4). The digital health solution will be based on the four original modules and an additional fifth module, covering information about management of hereditary cancer risk based on the most updated national recommendations.
Team members will develop a custom web application to collect baseline information from participants, deliver the intervention and the comparator, randomize participants, collect follow up data, facilitate users to send text and email messages to relatives and share genetic testing results. Readily available e-learning products will create different tailored messages, multiple interactions and assessments, and an interface that can be accessed on desktop and mobile devices. Stakeholders will review the content online and provide feedback on word choices, sensitivity of messages, and appearance of the website. The Korean team will develop a module on cancer risk management options and the Swiss team will adapt and tailor the remaining modules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Speak and read German, French, Italian, English, or Korean
- •Residence in Switzerland or in Korea
- •Has been identified with a pathogenic variant associated with HBOC or
- •Has ≥1 first-, second-degree relative or first cousing with HBOC
- •Mentally able to provide informed consent
排除标准
- •mutation carriers who do not have any family members;
- •husbands and partners, although they may play an important role in decisions for genetic testing and risk management of disease, will not be included in the study;
- •participants with a prior diagnosis of a mental disease and those unable to provide informed consent;
- •those physically ill and not being able to complete a baseline survey;
- •those without access to the web through a computer, tablet, or smartphone.
研究组 & 干预措施
Tailored Family Gene Toolkit
The tailored FGT will include 5 modules designed to increase knowledge of cancer genetics (1); provide decisional support for genetic testing (2); increase active coping to challenges faced by HBOC families (3); provide a 5-steps, skills-building communication training (4); and provide information about management of hereditary cancer risk (5).
Messages will involve shallow tailoring (e.g. sex of mutation carrier), and deep tailoring with complex elements of relevance (e.g. coping style). Tailoring will be based on personalization, tailored feedback, and content matching, based on Swiss and Korean languages and legislation, health insurance policy, and cultural values.
Participants will be asked to complete the 5 modules within 4 weeks after they first engage with the intervention. The 4-week interval will enable learning new information while having time to reflect and act. They will receive email alerts to complete the 5 modules with the URL link directing them to the FGT.
干预措施: Adapted Family Gene Toolkit (Other)
Targeted intervention
The comparator will provide targeted information about HBOC and enable sharing genetic test results. The Korean team will define the contents of the comparator that will mimic the structure and function of an existing website, already available in the US. The Korean team will create a translation process protocol, and share this guide for further translations from English into Korean and the three Swiss national languages. Both trial arms the tailored and the targeted platform will be technically implemented in the same system, in order to track access and usage of the platform and provide a user-friendly experience to participants. The Swiss team will also provide the implementation of the comparison website.
干预措施: Targeted intervention (Other)
结局指标
主要结局
Change in proportion of informed relatives
时间窗: Baseline, 2 months and 6 months post-intervention
Change in proportion of relatives that were invited to use the platform(s) over overall number of relatives eligible for cascade genetic testing
Effectiveness
时间窗: Baseline, 12 months, 24 months, 36 months, 48 months
Change in number of "relative invites" initiated through the website
Profile of Mood States (POMS)
时间窗: Baseline, 2 months and 6 months post-intervention
Change in psychological distress of mutation carriers and relatives. The higher the score the higher the psychological distress.
Implementation
时间窗: Baseline, 12 months, 24 months, 36 months, 48 months
Change in number of mutation carriers referred to the web-site
Maintenance
时间窗: Baseline, 12 months, 24 months, 36 months, 48 months
Change in number of visits to the web-site
Informing Relatives Inventory
时间窗: Baseline, 2 months and 6 months post-intervention
Change in intention of mutation carriers to inform relatives about pathogenic variant and need for cascade genetic testing. The higher the score the higher the intention to inform relatives.
Intention to have genetic testing
时间窗: Baseline, 2 months and 6 months post-intervention
1 item, 7-point Likert-type scale ranging from 1 to 7 and assessing change in intention of untested, at risk relatives to have genetic testing. The higher the score the higher the intention to have genetic testing.
Reach
时间窗: Baseline, 12 months, 24 months, 36 months, 48 months
Change in the absolute number of individuals willing to participate in the study
Adoption
时间窗: Baseline, 12 months, 24 months, 36 months, 48 months
Change in number of clinical sites willing to participate in the study
次要结局
- Cancer surveillance(Baseline, 12 months, 24 months, 36 months, 48 months)
- Decision regret(Baseline, 2 month and 6 month post-intervention)
- Acceptability - investigator developed(Baseline and 6 month post-intervention)
- K-CASCADE(through study completion, an average of 4 years)
- Brief Cope(Baseline, 2 month and 6 month post-intervention)
- Decision conflict(Baseline, 2 month and 6 month post-intervention)
- Cancer diagnoses(Baseline, 12 months, 24 months, 36 months, 48 months)
- Breast cancer risk factors and genetics knowledge index(Baseline, 2 month and 6 month post-intervention)
研究者
Maria Katapodi
Professor of Nursing, Department of Clinical Research
University of Basel