Patient Reported Symptoms in Ovarian Cancer (PRECISION)

Patient Reported Symptoms in Ovarian Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01422265

Enrollment

Registered

2011-08-23

Start date

2011-06-30

Completion date

2015-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Brief summary

This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred \> 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred \> 6 months after platinum-based chemotherapy * This must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma * Are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy * Are currently under observation or being treated with bevacizumab as a second-line maintenance therapy * Have a valid email address and access to the internet * Provide voluntary written informed consent * Speak and read English fluently

Exclusion criteria

* Current participation in a blinded clinical trial for ovarian cancer treatment. (Participation in a trial involving only supportive care medicines and/or growth factors is acceptable) * Another primary diagnosis of cancer in a different site

Design outcomes

Primary

Measure	Time frame
Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression	Up to 9 months

Secondary

Measure	Time frame
MDASI-OC Symptom Severity Score	Up to 9 months
MDASI-OC Symptom Interference Score	By month 9
HRQoL scores	Up to 9 months

Countries

United States

Outcome results