Clinical trial · Observational
Decision Making in Men With Early Stage Prostate Cancer Patients and Partners/Close Allies
NCT01877070CI-TRIAL-00116648active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessments | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- early stage prostate patients & their partners/close allies
- interventionNames
- Behavioral: assessments
Primary outcomes (1)
- measure
- evaluate the impact of anxiety and the inability to tolerate ambiguity
- timeFrame
- 2 years
- 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.
Secondary outcomes (1)
- measure
- how partners/close allies influence the decision making process
- timeFrame
- 2 years
- description
- participants will be administered a set of questionnaires that assess psychological and affective functioning, and treatment preferences.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.