Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-06 @ 10:56 AM
Study NCT ID:
NCT03287492
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2017-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT of QPS vs General Information Sheet
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of Two Different Information Materials in Patients With Advanced Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how well information materials work in helping communication between physicians and participants with cancer that has spread to other places in the body and their caregivers. Approaches that encourage participants to actively participate and ask appropriate questions during their visit may be important to enhance their understanding of their illness and empower them to make important decisions regarding their medical care.
Detailed Description:
PRIMARY OBJECTIVES:
I. To compare patients' perception of helpfulness in communicating with their physicians between a question prompt sheet (QPS) and a general information sheet (GIS).
SECONDARY OBJECTIVES:
I. To compare caregivers' perception of helpfulness in communicating with their physicians between the QPS and the GIS.
II. To examine the level of patients' and caregivers' overall satisfaction with the consultation with the use of the QPS versus the GIS.
III. To examine physicians' views about the information material and overall satisfaction with the use of the QPS versus the GIS.
IV. To explore how the use of QPS affects the average speaking time of patient or physician during the consultation visit.
V. To establish demographic and clinical predictors of patients' perception of helpfulness of a QPS.
VI. To examine the overall patients' preference between the QPS and GIS in an open label phase.
VII. To compare the change in patient anxiety state with the use of the QPS versus the GIS.
VIII. To explore the factors underlying patients' preferences for the QPS or GIS.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I: Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
GROUP II: Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
I. To compare patients' perception of helpfulness in communicating with their physicians between a question prompt sheet (QPS) and a general information sheet (GIS).
SECONDARY OBJECTIVES:
I. To compare caregivers' perception of helpfulness in communicating with their physicians between the QPS and the GIS.
II. To examine the level of patients' and caregivers' overall satisfaction with the consultation with the use of the QPS versus the GIS.
III. To examine physicians' views about the information material and overall satisfaction with the use of the QPS versus the GIS.
IV. To explore how the use of QPS affects the average speaking time of patient or physician during the consultation visit.
V. To establish demographic and clinical predictors of patients' perception of helpfulness of a QPS.
VI. To examine the overall patients' preference between the QPS and GIS in an open label phase.
VII. To compare the change in patient anxiety state with the use of the QPS versus the GIS.
VIII. To explore the factors underlying patients' preferences for the QPS or GIS.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I: Participants receive QPS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
GROUP II: Participants receive GIS and answer questions from physician. At follow up visit, participants receive both QPS and GIS.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: