Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04214210
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2019-11-03
Brief Title:
The DIALOGUE Study Swiss-Korean Billateral Collaboration
Sponsor:
University of Basel
Organization:
University of Basel
Study Overview
Official Title:
The DIALOGUE Study Using Digital Health to Improve Care for Families With Predisposition to Hereditary Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIALOGUE
Brief Summary:
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
1 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
2 Develop the K-CASCADE research infrastructure in Korea by expanding the research infrastructure developed by the CASCADE Consortium in Switzerland
3 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
4 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
Specific Aims
1 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
2 Develop the K-CASCADE research infrastructure in Korea by expanding the research infrastructure developed by the CASCADE Consortium in Switzerland
3 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
4 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
Detailed Description:
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
The linguistic and cultural adaptation of FGT will be based on literature regarding implementation of health interventions and specific elements for message tailoring The investigators will develop tailored messages in English and translate them into multilingual programs at the eighth grade reading level taking into account social norms legislation health insurance policy cultural values and social networks
Participants will be prompted to complete the five modules at their own pace within four weeks after they first engage with the intervention The four-week interval will enable them to learn information in a sequential manner and to have adequate time to reflect and act based on the provided information while also providing a controlled learning environment Tailored feedback will be based on responses to questions in the baseline assessment Within the four weeks they will receive email alerts to visit the website and complete the five modules with the URL link that will direct them to the adapted FGT
The comparison website will provide targeted information about HBOC and enable sharing genetic test results The Korean team will define the contents of the comparator website that will mimic the structure and function of an existing website and share a protocol for translations from English into Korean and Swiss languages
Mini-focus groups with clinicians involved in genetic counseling will evaluate if the content of each module and the tailored messages are appropriate for the target populations Focus groups with HBOC families will provide suggestions to enhance comprehensibility usefulness acceptability and feasibility of the intervention Feedback received from clinicians and focus groups will help with further refinement of the content of each module and the tailored messages
Usability and acceptability of a final version of the adapted FGT will be conducted with new members of the target population in each country Participants will be asked to think-aloud while navigating the website and voice their thoughts feelings and opinions while they are completing each task Usability testing will also help understand how to improve the interface Feedback will be analyzed and incorporated into final revisions of the digital platform
The Swiss sample will be identified through the five oncology and genetic testing centers participating in the CASCADE Consortium from three linguistic regions of Switzerland The Korean sample will be identified from similar clinics in Seoul Koyang and Daejeon
Focus groups with 20-24 participants 10-12 mutation carriers and 10-12 relatives will be conducted at national languages of each country There will be homogeneity within members of each focus group but the samples will be diversified in terms of demographics and clinical history between groups Usability and acceptability testing will be performed with 5 new mutation carriers per country and language version
Expert clinicians 6-10 involved in genetic consultation in each country and per linguistic region will be identified through the CASCADE Consortium and the SAKK Network in Switzerland and through the KOHBRA network in Korea
Recruitment for the focus groups will be done through the family-based cohort in Switzerland andor flyers advertising the study posted in the affiliated institutions and clinics and through social network service platforms in Korea Focus groups will be co-lead by two members of the research team in each country and each linguistic region in Switzerland Usability testing sessions will be videotaped Acceptability will be assessed with a seven-item survey assessing ease of use clarity appropriate length level of detail relevance interest and satisfaction
Focus groups with HBOC families and clinicians will be audio recorded and transcribed verbatim using codes to protect individual identification Transcripts will be reviewed and content analyzed Two members of the research team in each country will review the videotapes obtained from usability testing and the think aloud protocol Data about usability and acceptability will be analyzed with descriptive statistics
Aim 2 Develop the K-CASCADE research infrastructure in Korea by expanding an existing research infrastructure developed by the CASCADE Consortium in Switzerland
The design for K-CASCADE assessments and procedures for sample identification and data collection will follow procedures similar to the Swiss CASCADE study The investigators will use this infrastructure to measure the long-term outcomes of the randomized trial
Settings for recruitment will be open to interested member institutions within the KOHBRA network with attention towards diversity in hospital geographical location and other characteristics to increase sample representativeness and generalizability With an expected minimum of 5 hospital settings over a period of 3 years the accessible target population is estimated at 2700 persons 15 personsmonth x 12 months x 3 years x 5 hospitals of which 50-60 roughly 1350-1600 individuals are estimated to participate Korean men and women with an HBOC-associated pathogenic variant will be invited to participate and invite their first- and second-degree relatives and their first cousins to the study Investigators anticipate recruiting about 15 participants per month
Mutation carriers identified in participating centers will be invited to the study with an invitation letter signed by their physician Flyers will first be shared with clinicians via email andor face-to-face meetings and patient advertisements will be posted in the centers
For data collection on psychosocial variables the Swiss CASCADE platform will be used to maintain consistency and accuracy of data entry data cleaning and analyses Korean respondents will be able to log on as K-CASCADE participants through the Swiss CASCADE website and participate in the baseline survey For clinical data collection written consent will be obtained from Korean participants who agree to share their health data and their electronic medical records will be accessed and entered into a separate database by a Korean research associate
Korean participants data entered in the Swiss CASCADE platform will be available for descriptive and comparative analyses using their epidemiological and psychosocial data along with coded and non-identified clinical data
Aim 3 Explore the benefits of the digital platform on psychological distress and communication of genetic test results as well as knowledge of cancer genetics coping and decision making
The investigators will assess the feasibility of delivering the intervention and indicators of engagement obtained from meta-data such as the number of modules accessed time spent and the utilization of links which are automatically recorded on the website To assess intervention effects a randomized controlled trial evaluating the adapted FGT compared to a comparison website will be conducted Randomization will occur at the family level ie the platform will randomly assign each mutation carrier and relatives to either intervention arm Several instruments will be completed by all study participants at baseline T1 prior to the intervention and again 2 months T2 and 6 months T3 later
The Swiss sample will be identified through the oncology and genetic testing centers from three linguistic regions of Switzerland participating in the CASCADE Consortium The Korean sample will be identified from similar clinics at Seoul Koyang and Daejeon
The study will include 114 participants in order to have a total of N 104 evaluable families 52 for each website This sample size would allow detecting whether using the adapted FGT compared to the comparator website would increase the proportion of informed relatives by 25 with a statistical power of 80 a significance level of 5 and an expected drop-out rate of 9 The investigators assumed an average of 28 relatives per family and the distribution of the proportion of relatives based on data from the Swiss family-based cohort
The Swiss investigators anticipate identifying approximately 90 new mutation carriers per year from the five clinical centers affiliated with the CASCADE Consortium In Korea 150-250 new HBOC cases per year are estimated among the five participating institutions From the pool of potential participants it is expected that less than 10 have no relatives and less than 10 have no access to a computer tablet or smartphone making them ineligible for the study Based on similar studies it is expected that 75 of all eligible probands will participate in the study Investigators expect to recruit and retain the necessary final sample of 114 individuals with an HBOC associated pathogenic variant and their relatives in about 18 months
Potential participants carrying an HBOC-associated pathogenic variant will be emailed a code and the URL link to the website and a unique passcode to provide baseline assessments To alleviate ethical concerns in contacting relatives without their explicit consent mutation carriers will invite relatives to the website By providing a signed consent and completing the baseline survey mutation carriers and relatives indicate their participation to the study Eight weeks T1 and six months T2 after the first engagement with the intervention participants will receive an email reminder to log in to the website and complete the follow up survey Baseline and follow up surveys will each take about 30 minutes to complete
Pre- and post-intervention data values from self-administered surveys will be checked for validity Scales with alpha of 071 and higher will be used Missing data will be dealt with multiple imputation or other techniques The primary outcome will be calculated with a Wilcoxon-Mann-Whitney test to compare the proportions of informed relatives per study arm Other primary and secondary data and metadata from automatic recording of website activity will be analyzed with descriptive statistics including calculating means and frequencies of key variables and subject descriptors Chi-square test for differences in proportions and t-test for differences in means will assess the associations between demographic factors and clinical characteristics All analyses will be conducted using the statistical software R using two-sided statistical tests and confidence intervals with standard significance and confidence levels α 5 and 100 - α 95
Aim 4 Explore the reach effectiveness adoption implementation and maintenance of the digital platform
To explore the potential for dissemination and implementation of the adapted FGT the investigators will use the RE-AIM framework and explore reach effectiveness adoption implementation and maintenance of the adapted FGT at the individual and at the organizational level
Information about the different dimensions of the RE-AIM framework will be collected with different formats including refusal forms study evaluation questions at the follow up survey mini-interviews with non-participants and healthcare providers and systematically collecting feedback from clinical settings about rates of cascade genetic testing in each country
Data collected for Aim 4 will be analyzed with qualitative and quantitative methods presented in equivalent sections of Aim 1 and Aim 3 Narrative data obtained from mini-interviews will be audio recorded and transcribed verbatim and analyzed for common themes Descriptive analyses will include calculating means and frequencies of key variables and subject descriptors Chi-square test for differences in proportions and T-test for differences in means will compare key variables between participants and non-participants
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
The linguistic and cultural adaptation of FGT will be based on literature regarding implementation of health interventions and specific elements for message tailoring The investigators will develop tailored messages in English and translate them into multilingual programs at the eighth grade reading level taking into account social norms legislation health insurance policy cultural values and social networks
Participants will be prompted to complete the five modules at their own pace within four weeks after they first engage with the intervention The four-week interval will enable them to learn information in a sequential manner and to have adequate time to reflect and act based on the provided information while also providing a controlled learning environment Tailored feedback will be based on responses to questions in the baseline assessment Within the four weeks they will receive email alerts to visit the website and complete the five modules with the URL link that will direct them to the adapted FGT
The comparison website will provide targeted information about HBOC and enable sharing genetic test results The Korean team will define the contents of the comparator website that will mimic the structure and function of an existing website and share a protocol for translations from English into Korean and Swiss languages
Mini-focus groups with clinicians involved in genetic counseling will evaluate if the content of each module and the tailored messages are appropriate for the target populations Focus groups with HBOC families will provide suggestions to enhance comprehensibility usefulness acceptability and feasibility of the intervention Feedback received from clinicians and focus groups will help with further refinement of the content of each module and the tailored messages
Usability and acceptability of a final version of the adapted FGT will be conducted with new members of the target population in each country Participants will be asked to think-aloud while navigating the website and voice their thoughts feelings and opinions while they are completing each task Usability testing will also help understand how to improve the interface Feedback will be analyzed and incorporated into final revisions of the digital platform
The Swiss sample will be identified through the five oncology and genetic testing centers participating in the CASCADE Consortium from three linguistic regions of Switzerland The Korean sample will be identified from similar clinics in Seoul Koyang and Daejeon
Focus groups with 20-24 participants 10-12 mutation carriers and 10-12 relatives will be conducted at national languages of each country There will be homogeneity within members of each focus group but the samples will be diversified in terms of demographics and clinical history between groups Usability and acceptability testing will be performed with 5 new mutation carriers per country and language version
Expert clinicians 6-10 involved in genetic consultation in each country and per linguistic region will be identified through the CASCADE Consortium and the SAKK Network in Switzerland and through the KOHBRA network in Korea
Recruitment for the focus groups will be done through the family-based cohort in Switzerland andor flyers advertising the study posted in the affiliated institutions and clinics and through social network service platforms in Korea Focus groups will be co-lead by two members of the research team in each country and each linguistic region in Switzerland Usability testing sessions will be videotaped Acceptability will be assessed with a seven-item survey assessing ease of use clarity appropriate length level of detail relevance interest and satisfaction
Focus groups with HBOC families and clinicians will be audio recorded and transcribed verbatim using codes to protect individual identification Transcripts will be reviewed and content analyzed Two members of the research team in each country will review the videotapes obtained from usability testing and the think aloud protocol Data about usability and acceptability will be analyzed with descriptive statistics
Aim 2 Develop the K-CASCADE research infrastructure in Korea by expanding an existing research infrastructure developed by the CASCADE Consortium in Switzerland
The design for K-CASCADE assessments and procedures for sample identification and data collection will follow procedures similar to the Swiss CASCADE study The investigators will use this infrastructure to measure the long-term outcomes of the randomized trial
Settings for recruitment will be open to interested member institutions within the KOHBRA network with attention towards diversity in hospital geographical location and other characteristics to increase sample representativeness and generalizability With an expected minimum of 5 hospital settings over a period of 3 years the accessible target population is estimated at 2700 persons 15 personsmonth x 12 months x 3 years x 5 hospitals of which 50-60 roughly 1350-1600 individuals are estimated to participate Korean men and women with an HBOC-associated pathogenic variant will be invited to participate and invite their first- and second-degree relatives and their first cousins to the study Investigators anticipate recruiting about 15 participants per month
Mutation carriers identified in participating centers will be invited to the study with an invitation letter signed by their physician Flyers will first be shared with clinicians via email andor face-to-face meetings and patient advertisements will be posted in the centers
For data collection on psychosocial variables the Swiss CASCADE platform will be used to maintain consistency and accuracy of data entry data cleaning and analyses Korean respondents will be able to log on as K-CASCADE participants through the Swiss CASCADE website and participate in the baseline survey For clinical data collection written consent will be obtained from Korean participants who agree to share their health data and their electronic medical records will be accessed and entered into a separate database by a Korean research associate
Korean participants data entered in the Swiss CASCADE platform will be available for descriptive and comparative analyses using their epidemiological and psychosocial data along with coded and non-identified clinical data
Aim 3 Explore the benefits of the digital platform on psychological distress and communication of genetic test results as well as knowledge of cancer genetics coping and decision making
The investigators will assess the feasibility of delivering the intervention and indicators of engagement obtained from meta-data such as the number of modules accessed time spent and the utilization of links which are automatically recorded on the website To assess intervention effects a randomized controlled trial evaluating the adapted FGT compared to a comparison website will be conducted Randomization will occur at the family level ie the platform will randomly assign each mutation carrier and relatives to either intervention arm Several instruments will be completed by all study participants at baseline T1 prior to the intervention and again 2 months T2 and 6 months T3 later
The Swiss sample will be identified through the oncology and genetic testing centers from three linguistic regions of Switzerland participating in the CASCADE Consortium The Korean sample will be identified from similar clinics at Seoul Koyang and Daejeon
The study will include 114 participants in order to have a total of N 104 evaluable families 52 for each website This sample size would allow detecting whether using the adapted FGT compared to the comparator website would increase the proportion of informed relatives by 25 with a statistical power of 80 a significance level of 5 and an expected drop-out rate of 9 The investigators assumed an average of 28 relatives per family and the distribution of the proportion of relatives based on data from the Swiss family-based cohort
The Swiss investigators anticipate identifying approximately 90 new mutation carriers per year from the five clinical centers affiliated with the CASCADE Consortium In Korea 150-250 new HBOC cases per year are estimated among the five participating institutions From the pool of potential participants it is expected that less than 10 have no relatives and less than 10 have no access to a computer tablet or smartphone making them ineligible for the study Based on similar studies it is expected that 75 of all eligible probands will participate in the study Investigators expect to recruit and retain the necessary final sample of 114 individuals with an HBOC associated pathogenic variant and their relatives in about 18 months
Potential participants carrying an HBOC-associated pathogenic variant will be emailed a code and the URL link to the website and a unique passcode to provide baseline assessments To alleviate ethical concerns in contacting relatives without their explicit consent mutation carriers will invite relatives to the website By providing a signed consent and completing the baseline survey mutation carriers and relatives indicate their participation to the study Eight weeks T1 and six months T2 after the first engagement with the intervention participants will receive an email reminder to log in to the website and complete the follow up survey Baseline and follow up surveys will each take about 30 minutes to complete
Pre- and post-intervention data values from self-administered surveys will be checked for validity Scales with alpha of 071 and higher will be used Missing data will be dealt with multiple imputation or other techniques The primary outcome will be calculated with a Wilcoxon-Mann-Whitney test to compare the proportions of informed relatives per study arm Other primary and secondary data and metadata from automatic recording of website activity will be analyzed with descriptive statistics including calculating means and frequencies of key variables and subject descriptors Chi-square test for differences in proportions and t-test for differences in means will assess the associations between demographic factors and clinical characteristics All analyses will be conducted using the statistical software R using two-sided statistical tests and confidence intervals with standard significance and confidence levels α 5 and 100 - α 95
Aim 4 Explore the reach effectiveness adoption implementation and maintenance of the digital platform
To explore the potential for dissemination and implementation of the adapted FGT the investigators will use the RE-AIM framework and explore reach effectiveness adoption implementation and maintenance of the adapted FGT at the individual and at the organizational level
Information about the different dimensions of the RE-AIM framework will be collected with different formats including refusal forms study evaluation questions at the follow up survey mini-interviews with non-participants and healthcare providers and systematically collecting feedback from clinical settings about rates of cascade genetic testing in each country
Data collected for Aim 4 will be analyzed with qualitative and quantitative methods presented in equivalent sections of Aim 1 and Aim 3 Narrative data obtained from mini-interviews will be audio recorded and transcribed verbatim and analyzed for common themes Descriptive analyses will include calculating means and frequencies of key variables and subject descriptors Chi-square test for differences in proportions and T-test for differences in means will compare key variables between participants and non-participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None