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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Behavioral: Surveys; Behavioral: Interviews

• Registration Number: NCT05497024
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-08-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surveys	Surveys	Participants may answer questions that are sensitive in nature.
Interviews	Interviews	The interview may occur over phone, web conferencing, or in-person.

Primary Outcome Measures

Name	Time	Method
The Ottawa Acceptability Scale	through study completion and average of 1 year	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)

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States