Clinical trial · Interventional
Ovarian Cancer Patient-Centered Decision Aid
- 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 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.
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 |
|---|---|---|---|
| Stage III Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Aid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Decision Aid (PCOA)
- description
- PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.
- interventionNames
- Other: Decision Aid
- type
- NO_INTERVENTION
- label
- UC (Standard care)
- description
- Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.
Primary outcomes (2)
- measure
- Satisfaction With Decision
- timeFrame
- at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available