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JOURNAL ONKOLOGIE – STUDIE

DIALOGUE The DIALOGUE Study: Swiss-Korean Billateral Collaboration

Rekrutierend

NCT-Nummer:
NCT04214210

Studienbeginn:
März 2020

Letztes Update:
04.11.2020

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University of Basel

Collaborator:
Yonsei University, University Hospital, Basel, Switzerland, Hopital du Jura, Delemont, Switzerland, Department of Computer Science Yonsei University, Seoul, Korea, National Cancer Center, Korea, Chungnam National University, Ente Ospedaliero Cantonale, Ticino,

Studienleiter

Maria C. Katapodi, PhD
Principal Investigator
Department of Clinical Research, University of Basel

Kontakt

Studienlocations (3 von 4)

University Hospital Basel
4056 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Viola Heinzelmann-Schartz, MD
Phone: ++41612653654
E-Mail: Viola.Heinzelmann@usb.ch

Nicole Burki, MD
Phone: ++41615565883
E-Mail: nicole.buerki@usb.ch
» Ansprechpartner anzeigen
Istituto Oncologico della Zvizzera Italiana
6962 Bellinzona
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Rossella Graffeo, MD
Phone: +918118435
E-Mail: Rossella.GraffeoGalbiati@eoc.ch

Carla Pedrazzani, PhD
Phone: ++918118435
E-Mail: Carla.pedrazzani@unibas.ch
» Ansprechpartner anzeigen
Universitatklinik fur Medizinische Onkologie, Inselspital
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Manuela Rabaglio, MD
Phone: ++41316324370
E-Mail: Manuela.Rabaglio@insel.ch

Muriel Fluri, MSN
Phone: ++41316325944
E-Mail: muriel.fluri@insel.ch
» Ansprechpartner anzeigen
Unite d'Oncogenetique et de Prevention des Cancers
1205 Geneva
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Pierre Chappuis, MD, PhD
Phone: ++41223729853
E-Mail: Pierre.Chappuis@hcuge.ch

Monica Aceti, PhD
Phone: ++41223729853
E-Mail: monica.aceti@unibas.ch
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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 language(s) 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

and/or 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 2,700 persons (15 persons/month x 12 months x 3 years x 5 hospitals), of which

50-60% roughly 1,350-1,600 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 and/or 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, i.e., 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 2.8 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 0.71 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Studien-Rationale

Primary outcome:

1. Profile of Mood States (POMS) (Time Frame - 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.

2. Change in proportion of informed relatives (Time Frame - 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

3. Informing Relatives Inventory (Time Frame - 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.

4. Intention to have genetic testing (Time Frame - 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.

5. Reach (Time Frame - Baseline, 12 months, 24 months, 36 months, 48 months):
Change in the absolute number of individuals willing to participate in the study

6. Effectiveness (Time Frame - Baseline, 12 months, 24 months, 36 months, 48 months):
Change in number of "relative invites" initiated through the website

7. Adoption (Time Frame - Baseline, 12 months, 24 months, 36 months, 48 months):
Change in number of clinical sites willing to participate in the study

8. Implementation (Time Frame - Baseline, 12 months, 24 months, 36 months, 48 months):
Change in number of mutation carriers referred to the web-site

9. Maintenance (Time Frame - Baseline, 12 months, 24 months, 36 months, 48 months):
Change in number of visits to the web-site

Secondary outcome:

1. Acceptability - investigator developed (Time Frame - Baseline and 6 month post-intervention):
Change in attitude toward the intervention based on 16 items, 7 point Likert type scale. Minimum score 16, maximum 112, higher score indicates better acceptability

2. K-CASCADE (Time Frame - through study completion, an average of 4 years):
Number of individuals who take part in the study in Korea

3. Cancer diagnoses (Time Frame - Baseline, 12 months, 24 months, 36 months, 48 months):
Change in number of cancer diagnoses reported by participants

4. Cancer surveillance (Time Frame - Baseline, 12 months, 24 months, 36 months, 48 months):
Change in number of MRIs and mammograms reported by participants

5. Breast cancer risk factors and genetics knowledge index (Time Frame - Baseline, 2 month and 6 month post-intervention):
Change in genetic literacy and knowledge of genetic and epidemiological breast cancer risk factors. Minimum score 0, maximum score 36, higher score indicates higher knowledge of risk factors

6. Brief Cope (Time Frame - Baseline, 2 month and 6 month post-intervention):
Change in number of participants who engage in active coping e.g. information seeking vs. avoidance

7. Decision regret (Time Frame - Baseline, 2 month and 6 month post-intervention):
Change in decision regret for mutation carriers. Minimum score 5, maximum score 35, higher score means higher decision regret

8. Decision conflict (Time Frame - Baseline, 2 month and 6 month post-intervention):
Change in decision conflict for untested relatives. Minimum score 16, maximum score 112, higher score means higher decision conflict

Studien-Arme

  • Experimental: 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.
  • Active Comparator: 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.

Geprüfte Regime

  • Adapted Family Gene Toolkit:
    Five web-based 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); increase knowledge about management of hereditary cancer risk based on the most updated recommendations from the National Comprehensive Cancer Network (Module 5).
  • Targeted intervention:
    The comparison website will provide targeted information about HBOC and enable sharing genetic test results.The Korean team will define the contents of the comparison website that will mimic the structure and function of a 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 three Swiss national languages. The tailored and the targeted platform will be technically implemented in the same system, to track access and usage of the platform and provide a user-friendly experience.

Quelle: ClinicalTrials.gov


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