Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/20/2018
Start Date:June 2013
End Date:June 2019
Contact:Christian Nelson, PhD
Phone:646-888-0030

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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.

Each patient and his partner will fill out assessments at baseline. Thereafter we will obtain
the patients' treatment decision (AT or AS) within approximately 6 months. Once a patient
makes a decision, he and his partner will complete another set of questionnaires. The patient
and his partner will then complete the remaining questionnaires approximately 6, 12, 18, and
24 months following the treatment decision. We will examine the associations between baseline
assessments , and the treatment decision as well as the changes in the assessments and the
treatment decision. We will also assess associations between follow-up assessments and the
decision to change a treatment decision from AS to AT. Data from patients and partners/close
allies will generally be analyzed separately, thus patients who do not have a partner (or
partner declines to participate) can still be enrolled and their psychosocial outcomes
assessed.

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 consent or participating in the study
activities (i.e., acute psychiatric symptoms which require individual treatment)
We found this trial at
3
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Christian Nelson, PhD
Phone: 646-888-0030
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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500 Westchester Avenue
Harrison, New York 10604
Phone: 646-888-0030
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New York, New York 10029
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