Brief Title
Interactive Educational Website for Women With Ovarian Cancer & Caregivers
Official Title
Making End of Life Decision in Ovarian Cancer: When to Enter Hospice? A Prototype Interactive Computer Program for Patients and Providers
Brief Summary
Ovarian cancer accounts for more deaths than any other gynecologic malignancy. The majority
of patients are diagnosed with Stage III-IV disease. Nearly 80% of these patients will recur
resulting in 5-year survival rates of 14-32%. Although enrollment is increasing in hospice,
hospice programs have been challenged to reach eligible patients. Several factors limit the
number of people who enroll in hospice and the length of their hospice stay. Prognostication
challenges and the increasing availability of cancer therapies for people with cancer set the
stage for a mismatch between certification of a 6 month prognosis and contemporary medical
care. Additionally patients often are not aware of hospice and the services they can provide.
Detailed Description
In this study, we will pilot-test a technology-based approach for women with Stage III/IV or
recurrent ovarian cancer, their caregiver, and their providers to assist in and study the
decision-making process that surrounds end-of-life decisions, specifically, opting for
palliative care and/or entry into hospice care. We will randomize the women and their
caregivers into either our intervention or control websites. All subjects will complete a
battery of demographic, psychosocial, health status and outcomes, health information, and
decision making measures at baseline and 60-day post-baseline.
Once the participant has completed the baseline survey, he/she will be automatically brought
to their assigned website. Both the patient and their caregiver will be assigned the same
group (intervention or control). All participants will have open access to their respective
study websites for a minimum of 60 days. During enrollment, participants will agree to access
their respective websites at least 2-3 times per week. Both patients and caregivers assigned
to the control arm will view a website containing documents generally provided as part of the
usual care. They will be requested to log in with the same frequency as the intervention
group.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Comparison of Number of Women Who Completed Advanced Directive
Secondary Outcome
Comparison of Number of Women Who Report Appointment with Palliative Care
Condition
Stage III Ovarian Cancer
Intervention
Usual Care Educational Website
Study Arms / Comparison Groups
Intervention Group
Description: Using the Prototype System website: An interactive educational system for patients and their caregivers includes features allowing users to create their own profile, share a journal with others, and post to respective discussion forums. In addition, core intervention components include distress monitoring, educational items, details about the healthcare team and an areas to keep track of questions for providers.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
53
Start Date
August 2012
Completion Date
December 2014
Primary Completion Date
December 2014
Eligibility Criteria
Inclusion Criteria:
- Women with Stage III, IV or recurrent ovarian, primary peritoneal or fallopian tube
cancer or a nominated caregiver or such women
- 18 years old or older
- At least a 5th grade education
- Able to read and write in English
- Access to computer and internet
- Voluntary written informed consent before study entry, with the understanding that
consent may be withdrawn by the subject at any time without prejudice to future
medical care
- No known major psychiatric or neurological diagnosis (schizophrenia or active chemical
dependency)
Exclusion Criteria:
- Borderline ovarian cancer
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Melissa A. Geller, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01626014
Organization ID
2012NTLS005
Responsible Party
Sponsor
Study Sponsor
University of Minnesota
Study Sponsor
Melissa A. Geller, M.D., Principal Investigator, Masonic Cancer Center, University of Minnesota
Verification Date
November 2015