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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Risk Prostate Cancer
• Intervention / Treatment: Behavioral: assessments

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.

• Study Type: Observational
• Enrollment (Estimated): 541

Contacts and Locations

Study Locations

• United States
  • New York
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Family-Based
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
early stage prostate patients & their partners/close allies	Behavioral: assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the impact of anxiety and the inability to tolerate ambiguity	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.	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Yesne Alici, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 11, 2013
• First Posted (Estimated): June 13, 2013

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: assessments; 13-076
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 13-076