Clinical trial NCT01877070: Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
Official title: Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Low Risk Prostate Cancer
Keywords: assessments
13-076
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2013-06-13
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from outpatient clinics at both the Urology Service at Memorial Sloan-Kettering Cancer Center (MSKCC). Patients may also be contacted by e-mail (securely using MSKSecure) or by mail.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: evaluate the impact of anxiety and the inability to tolerate ambiguity
timeFrame: 2 years
Secondary outcomes:
measure: how partners/close allies influence the decision making process
timeFrame: 2 years
Other outcomes:
Locations:
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christian Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: