N/A
Completed N=124
Ovarian Cancer Patient-Centered Decision Aid
Source: ClinicalTrials.gov NCT02259699 ↗Enrolled (actual)
124
Serious AEs
—
Results posted
Jun 2019
Primary outcomePrimary: Satisfaction With Decision — 85.3; 86.9; 85.8; 91.5 transformed scale score — p=0.582
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Satisfaction With Decision |
85.3; 86.9; 85.8; 91.5; 87.1; 90.6 | 0.582 |
| PRIMARY Decisional Regret |
16.6; 11.7; 15.4; 15.0 | 0.087 |
| SECONDARY Shared Decision Making |
79.5; 78.7 | 0.807 |
| SECONDARY Satisfaction With Care (EORTC) Overall Quality Rating |
84.4; 90.9; 82.4; 86.9 | 0.071 |
| SECONDARY Cancer Therapy Satisfaction |
81.9; 85.8; 83.0; 81.9 | 0.177 |
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
Data sourced from ClinicalTrials.gov (NCT02259699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.