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

Active, not recruiting

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
early stage prostate patients & their partners/close allies	assessments	-

Primary Outcome Measures

Name	Time	Method
evaluate the impact of anxiety and the inability to tolerate ambiguity	2 years	on the decision making process in men with prostate cancer who are eligible for active surveillance and their partners/close allies. All participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.

Secondary Outcome Measures

Name	Time	Method
how partners/close allies influence the decision making process	2 years	participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.

Locations (3): Memorial Sloan Kettering Westchester
🇺🇸
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Mount Sinai Hospital
🇺🇸
New York, New York, United States

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