Interactive Educational Website for Women With Ovarian Cancer & Caregivers

This study is currently recruiting participants.
Verified October 2013 by Masonic Cancer Center, University of Minnesota
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01626014
First received: June 20, 2012
Last updated: October 8, 2013
Last verified: October 2013

June 20, 2012
October 8, 2013
August 2012
December 2013   (final data collection date for primary outcome measure)
Comparison of Number of Women Who Completed Advanced Directive [ Time Frame: Day 60 After Baseline ] [ Designated as safety issue: No ]
Count of number of women with ovarian cancer who completed a new or updated their Advanced Directive during the study period.
Same as current
Complete list of historical versions of study NCT01626014 on ClinicalTrials.gov Archive Site
Comparison of Number of Women Who Report Appointment with Palliative Care [ Time Frame: Day 60 After Baseline ] [ Designated as safety issue: No ]
Count of number of women with ovarian cancer who report an appointment with a Palliative Care specialist
Same as current
Not Provided
Not Provided
 
Interactive Educational Website for Women With Ovarian Cancer & Caregivers
Making End of Life Decision in Ovarian Cancer: When to Enter Hospice? A Prototype Interactive Computer Program for Patients and Providers

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.

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.

Interventional
Phase 0
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer
  • Recurrent Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • Behavioral: Usual Care Educational Website
    Using the control website: Participants access a website with standard ovarian cancer informational handouts.
  • 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.
  • 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.
    Intervention: Behavioral: Prototype System
  • 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).
    Intervention: Behavioral: Usual Care Educational Website
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Melissa Geller, M.D. 612-626-3111 gelle005@umn.edu
Contact: Matthew Gerber 612-624-9486 mhgerber@umn.edu
United States
 
NCT01626014
2012NTLS005
No
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Principal Investigator: Melissa A. Geller, M.D. Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP