Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies (NCT01877070) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
United States541 participantsStarted 2013-06
Plain-language summary
The purpose of this study is to collect information on how patients and their partners/close allies make treatment decisions when they have been diagnosed with early stage prostate cancer.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
For patients:
* Men who meet the NCCN guidelines for low risk prostate cancer, which include all of the following:
* Most recent Gleason score ≤ 6, or clinical stage T1a or less;
* Most recent PSA level below 10;
* In the most recent biopsy, had fewer than 3 positive biopsy cores (with ≤ 50% cancer in each); OR the patient's doctor discussed active surveillance as a treatment option (as documented in visit notes of the patient's medical record)
* Are able to speak, read, write and understand English well enough to provide informed consent and complete study tasks
* Has not made a treatment decision prior to consent, as per self report
* 18 years of age or older
For partners/close allies:
* Considered a partner/close ally to the patient in the treatment making decision, as reported by the patient
* Are able to speak, read, write and understand English well enough to provide informed consent and complete study tasks
* 18 years old or older
Exclusion Criteria:
For patients:
* History of a cancer other than prostate cancer and non-melanoma skin cancer
* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent or participating in the study activities (i.e., acute psychiatric symptoms which require individual treatment)
For partners/close allies:
* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed co…
What they're measuring
1
evaluate the impact of anxiety and the inability to tolerate ambiguity