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

This study is currently recruiting participants.
Verified March 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01877070
First received: June 11, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Low Risk Prostate Cancer
Behavioral: assessments

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • evaluate the impact of anxiety and the inability to tolerate ambiguity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • how partners/close allies influence the decision making process [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.


Estimated Enrollment: 288
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
early stage prostate patients & their partners/close allies

Each patient and his partner will fill out assessments at baseline. Thereafter we will obtain the patients' treatment decision (AT or AS) within approximately 3 months. Once a patient makes a decision, he and his partner will complete another set of questionnaires. We will examine the associations between baseline assessments and the treatment decision as well as the changes in the assessments and the treatment decision. 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.

We will also schedule interviews with approximately 36 patients and their partners/close allies to obtain the themes and subthemes of their decision-making. Those invited for interviews may or may not be from the same day.

Behavioral: assessments

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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) and the Department of Urology at Mount Sinai (MSSM). Patients may also be contacted by mail.

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 < than or = to 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 < than or = to 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01877070

Contacts
Contact: Christian Nelson, PhD 646-888-0030
Contact: Andrew Roth, MD 646-888-0024

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Christian Nelson, PhD    646-888-0030      
Contact: Andrew Roth, MD    646-888-0024      
Principal Investigator: Christian Nelson, PhD         
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Michael A Diefenbach, MD         
Principal Investigator: Michael Diefenbach, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Mount Sinai School of Medicine
Investigators
Principal Investigator: Christian Nelson, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01877070     History of Changes
Other Study ID Numbers: 13-076
Study First Received: June 11, 2013
Last Updated: March 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
assessments
13-076

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014