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A Social Media Approach to Improve Genetic Risk Communication Phase I

23. mai 2019 oppdatert av: M.D. Anderson Cancer Center
The goal of this research study is to create an internet-based program designed to improve the communication of health and health history information among family members affected by Lynch syndrome.

Studieoversikt

Detaljert beskrivelse

If you agree to take part in this study, you will be assigned to 1 of 3 groups based on when you joined the study.

Group 1:

If you are assigned to Group 1, you will take part in a focus group where you will be asked what you would want in a web-based program designed to improve the communication of health and health history information among family members affected by Lynch syndrome. You will also fill out a questionnaire with questions about your demographics (age, race, marital status) and your medical history. This visit should take about 1 hour to complete.

Group 2:

If you are assigned to Group 2, you will come to the Behavioral Research and Treatment Center (BRTC) at MD Anderson to use the initial version of the My Family Garden website. My Family Garden is designed to teach new ways of communicating about Lynch Syndrome and about other issues related to the disease (such as risks associated with the disease, etc.). You will be instructed on how to use the program by the study staff. After you use the website, you will have an interview where you will provide feedback on your session. You will be asked questions about your feelings about the website and about any possible improvements that could be made to the website. You will also fill out a questionnaire called the Website Analysis and MeasureMent Inventory (WAMMI) which is designed help rate websites. You will also fill out the demographics questionnaire described above.

You will be given the option of completing the WAMMI and demographics questionnaire at the BRTC after your session or at your home. If you choose to complete them at home, you will be provided with a self-addressed, postage-paid envelope so you can mail the questionnaires back to the study staff.

This visit should take about 90 minutes to complete.

Group 3:

If you are assigned to Group 3, you will use the final version of the My Family Garden website. This final version will include changes from the web designers after feedback has been given from the previous groups in this study.

After you use the website, you will have an interview where you will provide feedback on your session. You will be asked questions about your feelings about the website and about any possible improvements that could be made to the website. You will also fill out the WAMMI questionnaire and demographics questionnaire described above.

You will be given the option of coming to the BRTC at MD Anderson to use the My Family Garden computer program or using the program from your home. If you choose to use My Family Garden from your home, you will be given a secure, password-protected hyperlink via e-mail to access the program. You will be instructed on how to use the program by the study staff either in person or over the phone. If you use the program from your home, the study staff will give the interview over the phone. If you complete the questionnaire at your home, you will be provided with a self-addressed, postage-paid envelope so you can mail it back to the study staff.

Whether it is completed at MD Anderson or at home, this visit should last about 90 minutes.

Audiotapes:

All focus groups and interviews will be audiotaped. The audiotapes collected during the course of this study will be stored in locked file cabinets in a locked office and will be destroyed after 5 years.

Length of Study Participation:

Your participation in this study will be over after you have completed the study procedures described above.

This is an investigational study.

Up to 49 participants will be enrolled in this study. All participants will be enrolled at MD Anderson.

Studietype

Observasjonsmessig

Registrering (Forventet)

49

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Texas
      • Houston, Texas, Forente stater, 77030
        • University of Texas MD Anderson Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Participants recruited from Lynch syndrome families enrolled in the Human Pedigree Analysis Resource (HPAR), MDACC's hereditary cancer registry.

Beskrivelse

Inclusion Criteria:

  1. At least 18 years of age
  2. Able to read and speak english
  3. Completion of genetic counseling and testing for a Lynch syndrome mutation
  4. Persons with positive (i.e., carrier of Lynch syndrome MMR mutation) as well as indeterminate test results

Exclusion Criteria:

1) None

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Familiebasert
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Group 1
Patients participate in audiotaped focus group regarding web-based program, and fill out demographics questionnaire.
Participation in a focus group regarding web-based program designed to improve communication of health and health history information among family members affected by Lynch syndrome.
Complete questions about demographics (age, race, marital status) and medical history. This visit should take about 1 hour to complete.
Andre navn:
  • Undersøkelser
Group 2
Patients come to Behavioral Research and Treatment Center (BRTC) at MD Anderson to use initial version of My Family Garden website. Completion of Website Analysis and MeasureMent Inventory (WAMMI), and demographics questionnaires.
Complete questions about demographics (age, race, marital status) and medical history. This visit should take about 1 hour to complete.
Andre navn:
  • Undersøkelser

Group 2: Patients provide feedback regarding initial version of My Family Garden website.

Group 3: Patients provide feedback regarding final version of My Family Garden website.

Patients complete Website Analysis and MeasureMent Inventory. This visit should take about 90 minutes to complete.
Group 3
Patients use final version of My Family Garden website, and are interviewed which will be audiotaped. Completion of Website Analysis and MeasureMent Inventory (WAMMI), questionnaire and demographics questionnaire.
Complete questions about demographics (age, race, marital status) and medical history. This visit should take about 1 hour to complete.
Andre navn:
  • Undersøkelser

Group 2: Patients provide feedback regarding initial version of My Family Garden website.

Group 3: Patients provide feedback regarding final version of My Family Garden website.

Patients complete Website Analysis and MeasureMent Inventory. This visit should take about 90 minutes to complete.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluation of Internet-Based Program Among Lynch Syndrome Family Members
Tidsramme: 1 day
Quantitative analysis include descriptive statistics summarizing participants' demographic and clinical characteristics. Descriptive statistics calculated for each subscale of Website Analysis and MeasureMent Inventory (WAMMI) and for overall measure. Focus groups and interviews transcribed, coded and analyzed. Responses sorted into categorical and conceptual groups, field notes taken during user testing also used to aid in interpretation of interview data.
1 day

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Susan Peterson, MPH, PhD, M.D. Anderson Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2013

Primær fullføring (Forventet)

1. februar 2020

Studiet fullført (Forventet)

1. februar 2021

Datoer for studieregistrering

Først innsendt

18. juli 2012

Først innsendt som oppfylte QC-kriteriene

19. juli 2012

Først lagt ut (Anslag)

20. juli 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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