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Trial Title:
Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing
NCT ID:
NCT05497024
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Behavioral
Intervention name:
Interviews
Description:
Participants will discuss background, such as race, education, and living situation.
Participants will discuss Prostate cancer Participants will discuss feedback on the
educational material
Arm group label:
Interviews
Intervention type:
Behavioral
Intervention name:
Surveys
Description:
Participants may answer questions that are sensitive in nature.
Arm group label:
Surveys
Summary:
This protocol describes development and user testing of an educational shared decision
making intervention to help men with prostate cancer who are on active surveillance make
decisions with their health care providers about if and when to de-escalate surveillance
testing. The project is important because for many patients their cancer does not
progress to the point of needed curative treatment or their health status changes such
that they are no longer good candidates for treatment. For these men, de-escalating
ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.
Detailed description:
Objectives:
The overall goal of this protocol is to develop and refine an educational tool for use by
patients and health-care providers to help men with localized prostate cancer make
informed decisions about discontinuation of active surveillance.
- Conduct cognitive and initial usability and acceptability testing of a prototype
decision aid with patients
- Conduct cognitive and initial usability and acceptability testing of a prototype
decision aid with care partners/caregivers
- Conduct expert reviews of a prototype decision aid with clinicians
Criteria for eligibility:
Study pop:
M D Anderson Cancer Center
Sampling method:
Non-Probability Sample
Criteria:
Patients
Inclusion Criteria:
1. Males aged 65 or older
2. Diagnosis of localized prostate cancer
3. On active surveillance for 12 or more months
4. Fluent in English
Exclusion Criteria:
1. Receiving treatment for another cancer (primary or recurrence)
Caregivers
Inclusion Criteria:
1. Aged 18 or older
2. Fluent in English
3. Involved with the care of an eligible patient (i.e. partner, close friend, family
member, companion)
Exclusion Criteria:
4. None
Clinicians
Inclusion Criteria:
1. Aged 18 or older
2. Fluent in English
3. Provides clinical care for patients with prostate cancer (e.g. medical oncologists,
urologists, radiation oncologists, nurse practitioners, physician assistants)
Exclusion Criteria:
1. None
Gender:
Male
Gender based:
Yes
Gender description:
Male
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lisa Lowenstein, MD
Phone:
713-563-0020
Email:
deescalatepca@mdanderson.org
Investigator:
Last name:
Lisa Lowenstein, MD
Email:
Principal Investigator
Start date:
August 15, 2022
Completion date:
February 2, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05497024
http://www.mdanderson.org
