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

NCT ID: NCT01877070

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 541 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2026-06-30

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.

Conditions

Low Risk Prostate Cancer

Study Design

• Observational Model Type: FAMILY_BASED
• Study Time Perspective: PROSPECTIVE

Study Groups

early stage prostate patients & their partners/close allies

assessments

Intervention Type: BEHAVIORAL

Interventions

assessments

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Nelson, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Mount Sinai Hospital

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

13-076

Identifier Type: -

Identifier Source: org_study_id