Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing

Prostate Cancer Clinical Trial

Official title:

Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Cognitive and Usability Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497024
• Other study ID #: 2022-0375
• Secondary ID: NCI-2022-06569
• Status: Recruiting
• Start date: August 15, 2022
• Est. completion date: February 2, 2027

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Lisa Lowenstein, MD
• Phone: 713-563-0020
• Email: deescalatepca[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Interviews
Participants will discuss background, such as race, education, and living situation. Participants will discuss Prostate cancer Participants will discuss feedback on the educational material
• Surveys
Participants may answer questions that are sensitive in nature.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Ottawa Acceptability Scale	The Ottawa Acceptability scale includes 10 items to assess participant's rating of the educational material ease of use, clarity of information, length, level of detail provided, ability to hold one's interest, and satisfaction with how the materials prepared them for discussing the decision with their clinician; Score Scale (Strongly agree, Agree, Neither agree nor disagree, Disagree Strongly disagree) and (Not at all, A little, Somewhat, Quite a bit, A great deal)	through study completion and average of 1 year

External Links

•   MD Anderson Cancer Center