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Improving Health Literacy in African-American Prostate Cancer Patients

15 juni 2020 uppdaterad av: Kerry Kilbridge, Emory University
Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.

Investigators hypothesize that the delivery of a scripted, tailored, low literacy educational supplement will result in a statistically significant decrease in decisional conflict, and a statistically significant improvement in comprehension of cancer treatment and its side effects compared to standard practice.

The study team will measure patients' comprehension of treatment options and side effects, as well as decisional conflict; after standard practice, and again after exposure to the educational supplement. Investigators will compare the urologists' assessment of patients' 1) health literacy 2) preferences for side effects 3) stage of decision making, 4) treatment choice or predisposition toward treatment choice. 5) preference for role in decision making (active, passive, or shared with physician); to measures obtained from patients. These comparisons will allow investigators to quantify the potential benefit to the physician of information obtained through the interview and low literacy educational supplement.

Studietyp

Interventionell

Inskrivning (Faktisk)

160

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30303
        • Grady Memorial Hospital
      • Atlanta, Georgia, Förenta staterna, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, Förenta staterna, 30322
        • Emory University
      • Atlanta, Georgia, Förenta staterna, 30033
        • Atlanta VA Medical Center

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

25 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Beskrivning

Inclusion Criteria:

  • Patients who have undergone pathology review of their prostate biopsy at Emory University, Grady Memorial Hospital, Saint Joseph's Hospital, and Atlanta VA Medical Center with AJCC clinical stage T1-T2 prostate cancer by physical exam

Exclusion Criteria:

  • RN or MD degree
  • History of head injury or dementia
  • History of cognitive impairment
  • Unable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist or urological provider

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: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Educational Supplement
Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.
Övrig: Educational Supplement
Participants will receive education about prostate cancer and treatments using models and props during a face-to-face interview. During the interview, participants will also be asked about medical terms and treatments regarding prostate cancer. The interview will last 45 to 60 minutes.
Övrig: Standard Practice Education
Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Decisional Conflict Scale Score
Tidsram: Baseline, Post-Intervention (Up to 6 Weeks)
The decisional conflict scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Baseline, Post-Intervention (Up to 6 Weeks)
Change in Comprehension of Treatment Options Score assessed by Interview
Tidsram: Baseline, Post-Intervention (Up to 6 Weeks)
Comprehension of treatment options will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand treatment after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
Baseline, Post-Intervention (Up to 6 Weeks)
Change in Comprehension of Side Effects Score assessed by Interview
Tidsram: Baseline, Post-Intervention (Up to 6 Weeks)
Comprehension of side effects will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand side effects after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
Baseline, Post-Intervention (Up to 6 Weeks)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rapid Estimate of Adult Literacy in Medicine (REALM) Score
Tidsram: Baseline

The REALM is a screening instrument to assess an adult patient's ability to read common medical words and lay terms for body parts and illnesses. Scores are assessed on an education grade equivalent;

0-18 = 3rd Grade and Below Will not be able to read most low literacy materials; will need repeated oral instructions, materials composed primarily of illustrations, or audio or video tapes

19-44 = 4th to 6th Grade Will need low literacy materials; may not be able to read prescription labels

45-60 = 7th to 8th Grade Will struggle with most patient education materials

61-66 = High School Will be able to read most patient education materials
Baseline
Change in the Stage of Decision Making Scale Score
Tidsram: Baseline, Post-Intervention (Up to 6 Weeks)
Stage of decision making refers to individual's readiness to engage in decision making, progress in making a choice, and receptivity to considering or re-considering options. This tool is not scored. However, the categories can be used to determine co-variation in decisional conflict (tends to be higher in earlier stages) and success of interventions (success higher among those in active deliberation stage).
Baseline, Post-Intervention (Up to 6 Weeks)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Emory University

Samarbetspartners

United States Department of Defense

Utredare

  • Huvudutredare: Kerry Kilbridge, MD, Dana-Farber Cancer Institute

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)

21 juli 2016

Primärt slutförande (Faktisk)

18 december 2018

Avslutad studie (Faktisk)

17 januari 2019

Studieregistreringsdatum

Först inskickad

23 oktober 2017

Först inskickad som uppfyllde QC-kriterierna

23 oktober 2017

Första postat (Faktisk)

26 oktober 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 juni 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 juni 2020

Senast verifierad

1 juni 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00091879

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Obeslutsam

Läkemedels- och apparatinformation, studiedokument

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produkt tillverkad i och exporterad från U.S.A.

Nej

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 .

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