Clinical trial NCT02259699: Ovarian Cancer Patient-Centered Decision Aid
Official title: Ovarian Cancer Patient-Centered Decision Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage III Ovarian Cancer
Keywords: Ovarian Cancer
Intraperitoneal chemotherapy
Intravenous chemotherapy
decision making
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-10-08
Enrollment: 124
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to develop and test a new decision aid -named Patient Centered Outcome Aid (PCOA)-that will allow patients to assimilate information and identify trade-offs about the impact of IP/IV therapy versus IV-only therapy on their QOL and survival, based on their own preferences and personal clinical characteristics, described in terms that are meaningful to them. To accomplish this, the investigators will 1)develop the PCOA, a patient- and provider-friendly decision aid and 2)test the effectiveness of PCOA through a randomized controlled trial (RCT).

The investigators hypothesize that PCOA will be significantly better than usual care, resulting in patients reporting more satisfaction with their treatment decision, less decision regret, better quality of life, and more satisfaction with their care compared with similar patients not having access to PCOA. If these hypotheses are substantiated, patients and providers will have an improved model for communication and decision making, leading to better patient outcomes.

Detailed description: Ovarian cancer is typically diagnosed at an advanced stage and carries the highest fatality-to-case ratio of all gynecologic malignancies diagnosed in the United States. Arguably the most effective treatment regimen to date is provided through intraperitoneal (IP) chemotherapy delivery, together with intravenous (IV) chemotherapy, which in the most recent phase III randomized trial conferred the longest median survival (65.6 months) ever reported in advanced ovarian cancer, compared to 49.7 months in the IV-only treatment arm. However, during active treatment, patients randomized to the IP therapy group reported significantly worse quality of life (QOL), and more treatment-related toxicities. In short, women are less likely to die if they receive an IP component to their chemotherapy, a finding that was underscored by an NCI Clinical Alert. However, there may be greater toxicity with IP treatment. The tradeoff between short-term reduced QOL and longer survival is difficult for patients to understand and then incorporate meaningfully into their decision-making process. In fact, for reasons that are not entirely clear, many patients are not offered IP therapy. Patient-centered care requires that they be given the opportunity to participate in treatment decision-making.

Eligibility criteria: Inclusion Criteria:

* RCT participants will include stage III optimally debulked advanced ovarian cancer patients from urban and rural regions of the country, who will be randomized to either our patient-centered decision-aid or the usual care control arm

Exclusion Criteria:

* By the nature of the neoplasm under study, gender specific (ovarian cancer), only female patients will be included
* Patient enrollment will include women from all English speaking ethnic groups

  -\> the age of 21
* All minority ovarian cancer survivors will be eligible
* Women under age 21 will not be included in this study because it is not common to be diagnosed with advanced epithelial ovarian cancer in females under age 21

Primary outcomes:
measure: Satisfaction With Decision
timeFrame: at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)
measure: Decisional Regret
timeFrame: At treatment completion (T3) and 9 months post enrollment (T4)
Secondary outcomes:
measure: Shared Decision Making
timeFrame: at treatment initiation (T1)
measure: Satisfaction With Care (EORTC) Overall Quality Rating
timeFrame: at treatment completion (T3) and 9 months post enrollment (T4)
measure: Cancer Therapy Satisfaction
timeFrame: at treatment completion (T3) and 9 months post enrollment (T4)
Other outcomes:
measure: Process Outcome - Satisfaction With PCOA Aid
timeFrame: at treatment initiation
Locations:
city: Irvine
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Irvine
name: Lari Wenzel, PhD
role: PRINCIPAL_INVESTIGATOR
References: