Enhancing informed consent in cancer clinical trials;development and evaluation o

Information

  • Research Project
  • 7492835
  • ApplicationId
    7492835
  • Core Project Number
    R03CA130598
  • Full Project Number
    5R03CA130598-02
  • Serial Number
    130598
  • FOA Number
    PAR-06-458
  • Sub Project Id
  • Project Start Date
    9/4/2007 - 17 years ago
  • Project End Date
    8/31/2010 - 14 years ago
  • Program Officer Name
    AGURS-COLLINS, TANYA
  • Budget Start Date
    9/1/2008 - 16 years ago
  • Budget End Date
    8/31/2010 - 14 years ago
  • Fiscal Year
    2008
  • Support Year
    2
  • Suffix
  • Award Notice Date
    8/29/2008 - 16 years ago

Enhancing informed consent in cancer clinical trials;development and evaluation o

[unreadable] DESCRIPTION (provided by applicant): Doctor patient communication about clinical trials is problematic. Increasing patient participation in consultations is associated with better patient outcomes. One method that has demonstrated significant promise in aiding doctor-patient communication are Question Prompt Lists (QPLs). QPLs consist of a list of sample written questions separated into content categories. These simple patient interventions have not been tested in the oncology clinical trial setting. Questions vary across oncology contexts. The results of studies using context-specific QPLs suggest that they are well received by patients and increase specific types of questions asked. The pilot research proposed in this study will develop and evaluate the acceptability of a QPL specific to oncology clinical trials. The utility of this new QPL will be assessed in the clinical setting using a novel measure, the question match ratio. The specific aims of this exploratory study are to; 1) develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients and 2) explore the utility of the QPL for Clinical Trials in oncology consultations containing a discussion of a Phase I, II or III clinical trial. In stage 1 of the proposed study, (i) lung, breast and prostate cancer patients and their carers and (ii) health care professionals, will participate in separate focus groups to help develop and explore the acceptability of a QPL for Clinical Trials Question list. A qualitative analysis expert will analyze these data. This analysis will inform a final version of the QPL. Stage 2 of the project involves pilot testing the QPL in a sample of lung, prostate and breast cancer patients to explore the utility of the question list and patient satisfaction with the consultation. Prior to their clinical trial, patients will be asked to use the QPL by circling questions they would like to ask. They will complete pre- consultation information and involvement preference scales and post consultation achievement of involvement preferences and satisfaction with the consultation scale. The consultations will be audiotaped, transcribed and coded and these data analyzed using a new measure, the Question Match Ratio. This ratio will be compared with patient satisfaction and preference data to determine the utility of the QPL. It is anticipated that these data will be used to establish the acceptability and utility of the QPL in oncology clinical trial context and providing an evidence base for a proposed randomized clinical trial of the QPL. Patient-doctor communication is often problematic as patients commonly misunderstand trial information and do not achieve their preferences for decision involvement. By creating a question prompt list specifically for discussions concerning clinical trials, patients will gain a better understanding of the clinical trial process and therefore feel more comfortable with the accrual process. This could improve accrual rates as well as communication between doctors and patients. [unreadable] [unreadable] [unreadable]

IC Name
NATIONAL CANCER INSTITUTE
  • Activity
    R03
  • Administering IC
    CA
  • Application Type
    5
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    93500
  • Sub Project Total Cost
  • ARRA Funded
  • CFDA Code
    393
  • Ed Inst. Type
  • Funding ICs
    NCI:93500\
  • Funding Mechanism
  • Study Section
    ZCA1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    SLOAN-KETTERING INSTITUTE FOR CANCER RES
  • Organization Department
  • Organization DUNS
    064931884
  • Organization City
    NEW YORK
  • Organization State
    NY
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    10065
  • Organization District
    UNITED STATES