Making End of Life Decision in Ovarian Cancer: When to Enter Hospice? A Prototype Interactive Computer Program for Patients and Providers
18 Years
N/A
Female
Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Recurrent Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
Trial Information
Making End of Life Decision in Ovarian Cancer: When to Enter Hospice? A Prototype Interactive Computer Program for Patients and Providers
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.
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consent may be withdrawn by the subject at any time without prejudice to future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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Comparison of Number of Women Who Completed Advanced Directive
Outcome Description:
Count of number of women with ovarian cancer who completed a new or updated their Advanced Directive during the study period.
Outcome Time Frame:
Day 60 After Baseline
Safety Issue:
No
Principal Investigator
Melissa A. Geller, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Institutional Review Board
Study ID:
2012NTLS005
NCT ID:
NCT01626014
Start Date:
August 2012
Completion Date:
December 2013
Related Keywords:
- Stage III Ovarian Cancer
- Stage IV Ovarian Cancer
- Recurrent Ovarian Cancer
- Primary Peritoneal Cancer
- Fallopian Tube Cancer
- Stage III ovarian cancer
- Stage IV ovarian cancer
- recurrent ovarian cancer
- primary peritoneal cancer
- fallopian tube cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis, Minnesota 55455 |
