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

Low Risk Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01877070
• Other study ID #: 13-076
• Status: Active, not recruiting
• Start date: June 2013
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 541
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Low Risk Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• assessments

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Memorial Sloan Kettering Cancer Center