Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Efficacy Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This protocol describes pilot testing of an educational shared decision-making intervention to help men with localized prostate cancer 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
Primary Objective:
The overall goal of this protocol is to test initial efficacy of three versions of 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. A pre-post design was selected to provide initial efficacy data of the different versions of the shared decision-making intervention. Thereby, providing preliminary data in preparation for a follow-up comparative study.
Primary outcome measures
- Preparation for Decision Making Scale [Time frame: Through study completion and average of 1 year]
Eligibility criteria
Inclusion criteria
Patients:
- Males aged 65 or older
- Diagnosis of localized prostate cancer
- Have not received curative intent treatment for their prostate cancer
- Fluent in English
Care partners/caregivers:
- Aged 18 or older
- Fluent in English
- Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)
Exclusion criteria
Patients
1\. Currently receiving treatment for another cancer (primary or recurrence)
Care partners/caregivers
1\. None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- M.D. Anderson Cancer Center — Houston
Identifiers
NCT: NCT06785441 · 2023-0128