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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age65+
SponsorM.D. Anderson Cancer Center

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • Interviews

    Behavioral

    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

    Behavioral

    Participants may answer questions that are sensitive in nature.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Surveys1 intervention
Group B: Interviews1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
through study completion and average of 1 year

Secondary outcomes

Other outcomes

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