About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males aged 65 or older
Diagnosis of localized prostate cancer
On active surveillance for 12 or more months
Fluent in English
Disqualifiers
Aged 18 or older
Fluent in English
Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)
None
Trial population
M D Anderson Cancer Center
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Interviews
BehavioralParticipants will discuss background, such as race, education, and living situation. Participants will discuss Prostate cancer Participants will discuss feedback on the educational material
Surveys
BehavioralParticipants may answer questions that are sensitive in nature.
Treatment groups
Trial outcomes
Primary outcomes
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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
American Cancer Society, Inc.
Collaborator