Ovarian Cancer Patient-Centered Decision Aid

NCT02259699 | Completed Results

• 1 other identifier: PCORI CE-12-11-4755
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage III Ovarian Cancer

Keywords

Ovarian Cancer; Intraperitoneal chemotherapy; Intravenous chemotherapy; decision making

Outcome Measures

Primary Outcomes (2)

• Satisfaction With Decision

  Satisfaction with Decision scale (SWD) is a 6-item scale measuring satisfaction with health care decisions, developed and validated in the context of women making decisions about hormone replacement therapy, and subsequently validated in adults with depression making decisions about treatment. The scale has good internal consistency reliability (alpha = 0.85), evidence of construct validity, relevance to designing and assessing patient-centered decision support interventions, and is sensitive to changes in information in trials of decision aids. The scale uses a 1-5 rating (1=strongly disagree; 5 = strongly agree). Scores from these 6 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with the decision.

  at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)

• Decisional Regret

  The Decision Regret Scale is a 5-item scale which is a reliable and valid indicator of health care decision regret at a given point in time, with excellent psychometric properties. In this study, the question stem will ask "about the decision you made about selecting IP/IV treatment." Total scores were linearly transformed to a 0-100 scale. The lowest possible score, 0, means no regret. The highest possible score, 100, means high regret. This outcome will be measured from T2 - T4, but is not appropriate to ask at the time of the T1 assessment, which is just after the treatment decision has been made, but prior to treatment delivery. Use of this measure will allow us to evaluate whether the PCOA, compared to usual care, helps to reduce regret during and after cancer treatment.

  At treatment completion (T3) and 9 months post enrollment (T4)

Secondary Outcomes (3)

• Shared Decision Making

  at treatment initiation (T1)

• Satisfaction With Care (EORTC) Overall Quality Rating

  at treatment completion (T3) and 9 months post enrollment (T4)

• Cancer Therapy Satisfaction

  at treatment completion (T3) and 9 months post enrollment (T4)

Other Outcomes (1)

• Process Outcome - Satisfaction With PCOA Aid

  at treatment initiation

Study Arms (2)

Decision Aid (PCOA)

EXPERIMENTAL

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.

Other: Decision Aid

UC (Standard care)

NO INTERVENTION

Standard pamphlets will be given to patients to educate them about IV and IV/IP therapies.

Interventions

Decision Aid OTHER

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.

Also known as: Patient Centered Outcome Aid (PCOA)

Decision Aid (PCOA)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of California

Irvine, California, 92697, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Lari Wenzel
• Organization: University of California, Irvine

lwenzel@uci.edu

949-824-3926

Study Officials

• Lari Wenzel, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: October 8, 2014
• Study Start: December 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-03

Locations

US (1)