Increasing Minority Participation in Clinical Trials
7 september 2017 uppdaterad av: Consuelo H Wilkins, Vanderbilt University Medical Center
Increasing Minority Group Participation in Clinical Trials a Randomized Controlled Study of an Office-based Educational Video
This study will measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation.
This study will also determine the feasibility of implementing an office-based video educational program.
Studieöversikt
Detaljerad beskrivning
Clinical trials are essential to scientific discovery and are critical to translating research in to practice. Despite their significance, clinical trial participation rates remain low, especially among underrepresented minority groups. Several barriers exist to minority group participation in clinical trial, one of which lack of awareness about clinical trials. Video educational programs show promise as an effective strategy to increase knowledge and clinical trial participation. The specific aims are as follows:
- Measure the effects of an office-based, clinical trial education video on clinical trial knowledge and enrollment in clinical trials, in a clinical sample with no previous history of clinical trial participation.
- Determine the feasibility of implementing an office-based video educational program.
Studietyp
Interventionell
Inskrivning (Faktisk)
63
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer Participants will have no previous history of clinical trial research participation
Exclusion Criteria:
- Previous history of clinical trial research participation
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: Standard care/control group
First, participants will complete a brief electronic survey measuring their opinions on clinical trials.
Next, participants in the standard of care group will be provided standard educational resources (booklet and DVD), with no additional instructions.
Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
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Experimentell: Video viewing group
First, participants will complete a brief electronic survey measuring their opinions on clinical trials.
Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic.
Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
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First, participants will complete a brief electronic survey measuring their opinions on clinical trials.
Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic.
Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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study feasibility
Tidsram: 12 months
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The stages of implementation completion (SIC) measure will be used as an internal tool utilized by the study team to track time to achievement of key implementation milestones.
An 8-stage implementation plan to measure feasibility of the office-based educational program will be executed across 3 phases.
Three scores will be derived from the SIC measure.
The first score is the number of stages completed.
The second score is the time spent at each stage.
The third score is the proportion of activities completed at each stage.
Implementation of the SIC model poses no additional burden on study participants.
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12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Clinical trial participation
Tidsram: 12 months
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Information on clinical trial participation will be collected by a team member by reviewing the participants' health record and by contacting the VICC clinical trial team.
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12 months
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Clinical trial knowledge survey
Tidsram: 7-10 days
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This survey consist of 22-items assessing a participants views on clinical trials on 5 domains (positive beliefs, safety, information needs, negative expectations, and patient involvement).
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7-10 days
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Likelihood to participate survey
Tidsram: 7-10 days
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This survey consist of 5-items assessing reasons for not participating in research, views about sources of research, views about sharing of research data, trust, and willingness to advise research teams.
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7-10 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Consuelo H. Wilkins, MD, Meharry-Vanderbilt Alliance, Vanderbilt University Medical Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2014
Primärt slutförande (Faktisk)
28 juni 2017
Avslutad studie (Faktisk)
28 juni 2017
Studieregistreringsdatum
Först inskickad
5 november 2015
Först inskickad som uppfyllde QC-kriterierna
6 november 2015
Första postat (Uppskatta)
9 november 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 september 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 september 2017
Senast verifierad
1 september 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 14117
- P30CA068485 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .