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

NCT01877070 | Active Not Recruiting

• 1 other identifier: 13-076
• Study Type: observational
• Target: 541
• Locations: 1 country
• Sites: 3

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.

Conditions

Low Risk Prostate Cancer

Keywords

assessments; 13-076

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• how partners/close allies influence the decision making process

  2 years

Study Arms (1)

early stage prostate patients & their partners/close allies

Behavioral: assessments

Interventions

assessments BEHAVIORAL

early stage prostate patients & their partners/close allies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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
• years old or older

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (3)

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Yesne Alici, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 13, 2013
• Study Start: June 1, 2013
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

US (3)