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Active, Not Recruiting

NCT Number: NCT01877070

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Westchester, Harrison, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Assessments

Behavioral

Primary outcomes

  1. evaluate the impact of anxiety and the inability to tolerate ambiguity

    Time frame: 2 years

    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 outcomes

  1. how partners/close allies influence the decision making process

    Time frame: 2 years

    participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2013
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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