Clinical trial NCT01626014: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Recurrent Ovarian Cancer
Fallopian Tube Cancer
Keywords: Stage III ovarian cancer
Stage IV ovarian cancer
recurrent ovarian cancer
primary peritoneal cancer
fallopian tube cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Comparison of Number of Women Who Completed Advanced Directive
timeFrame: Day 60 After Baseline
Secondary outcomes:
measure: Comparison of Number of Women Who Report Appointment with Palliative Care
timeFrame: Day 60 After Baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Melissa A. Geller, M.D.
role: PRINCIPAL_INVESTIGATOR
References: