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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

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