Table 2.

Schedule of study-related evaluations

VariableBefore enrollingBaselineEvery 3 moEvery 6 moBaseline, 6, 12, 24, and 60 mo6, 12, 24, 36, 48, 60 moAnnualAs needed
Cancer genetic risk assessmentX*
Eligibility assessmentX
Choice of treatmentX
History and physical examinationX
Baseline QuestionnaireX
Quality of Life InstrumentsX
Medical Decision-Making formXX§
Health Outcome Follow-up formX
Cancer Incidence formXX
Cancer Follow-up formX
Pathology reportX RRSOX
CA-125 for ROCAXX ScreeningX RRSO
Mammogram (recommended)X
Whole blood (for DNA)X
Serum, plasmaXX ScreeningX RRSO
  • * BRCAPRO calculation if necessary.

  • May have been done up to 6 wk (42 d) before the date of study enrollment. Pelvic examination was not required.

  • Only patients enrolled before April 26, 2006 and include the following instruments: Medical Outcome Study Short Form-36, Impact of Events Scale, Center for Epidemiological Studies Depression Scale, Speilberger State-Trait Anxiety Scale, Sexual Activity Questionnaire, Multidimensional Impact of Cancer Risk Assessment, and Endocrine Subscale of the FACT.

  • § Medical Decision-Making form will also be completed when participants enrolled in the screening cohort of the study choose to undergo RRSO.

  • The Cancer Follow-up form is to be completed only for patients who are diagnosed with cancer and complete a Q0-0199 (Treatment Completion form).

  • For participants who undergo RRSO after having enrolled in the screening cohort of the study and for women who develop primary peritoneal carcinomatosis after having undergone RRSO.

  • ** May have been done up to 3 mo (90 d) before the date of study enrollment as long as a report could be obtained.

  • †† As dictated by ROCA.