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Decision Making for Active Surveillance in Prostate Cancer Patients and Partners/Close Allies


N/A
18 Years
N/A
Open (Enrolling)
Both
Low Risk Prostate Cancer

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Trial Information

Decision Making for Active Surveillance in Prostate Cancer Patients and Partners/Close Allies


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, 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); and

- 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)

Type of Study:

Observational

Study Design:

Observational Model: Family-Based, Time Perspective: Prospective

Outcome Measure:

evaluate the impact of anxiety and the inability to tolerate ambiguity

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Christian Nelson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

13-076

NCT ID:

NCT01877070

Start Date:

June 2013

Completion Date:

June 2015

Related Keywords:

  • Low Risk Prostate Cancer
  • assessments
  • 13-076
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Mount Sinai HospitalNew York, New York  10029