Interactive Educational Website for Women With Ovarian Cancer & Caregivers
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|ClinicalTrials.gov Identifier: NCT01626014|
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : December 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stage III Ovarian Cancer Stage IV Ovarian Cancer Recurrent Ovarian Cancer Fallopian Tube Cancer||Behavioral: Usual Care Educational Website Behavioral: Prototype System||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Making End of Life Decision in Ovarian Cancer: When to Enter Hospice? A Prototype Interactive Computer Program for Patients and Providers|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Intervention Group
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.
Behavioral: Prototype System
An interactive 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.
Active Comparator: Control Group
Using the Usual Care Educational Website : a website which will contain information regarding ovarian cancer however it will not be interactive. It will contain pdf documents of the material handed out in clinic (usual care).
Behavioral: Usual Care Educational Website
Using the control website: Participants access a website with standard ovarian cancer informational handouts.
- Comparison of Number of Women Who Completed Advanced Directive [ Time Frame: Day 60 After Baseline ]Count of number of women with ovarian cancer who completed a new or updated their Advanced Directive during the study period.
- Comparison of Number of Women Who Report Appointment with Palliative Care [ Time Frame: Day 60 After Baseline ]Count of number of women with ovarian cancer who report an appointment with a Palliative Care specialist
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626014
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Melissa A. Geller, M.D.||Masonic Cancer Center, University of Minnesota|