Prostate Cancer
Conditions
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
Interventions
BEHAVIORALInterviews
Participants will discuss background, such as race, education, and living situation. Participants will discuss Prostate cancer Participants will discuss feedback on the educational material
BEHAVIORALSurveys
Participants may answer questions that are sensitive in nature.
Sponsors
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
CONTACTLisa Lowenstein, MD
PRINCIPAL_INVESTIGATORLisa Lowenstein, MD
M.D. Anderson Cancer Center
Outcome results
None listed