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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 11, 2014
Last verified: September 2014

June 11, 2013
September 11, 2014
June 2013
June 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01877070 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies

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.

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. 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.

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.

Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Low Risk Prostate Cancer
Behavioral: assessments
early stage prostate patients & their partners/close allies
Intervention: Behavioral: assessments
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
288
June 2015
June 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Yes
Contact: Christian Nelson, PhD 646-888-0030
Contact: Andrew Roth, MD 646-888-0024
United States
 
NCT01877070
13-076
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Mount Sinai School of Medicine
Principal Investigator: Christian Nelson, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP