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Interactive Educational Website for Women With Ovarian Cancer & Caregivers

Primary Purpose

Stage III Ovarian Cancer, Stage IV Ovarian Cancer, Recurrent Ovarian Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Usual Care Educational Website
Prototype System
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage III Ovarian Cancer focused on measuring Stage III ovarian cancer, Stage IV ovarian cancer, recurrent ovarian cancer, primary peritoneal cancer, fallopian tube cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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  • Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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

Sites / Locations

  • Masonic Cancer Center, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm 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.

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).

Outcomes

Primary Outcome Measures

Comparison of Number of Women Who Completed Advanced Directive
Count of number of women with ovarian cancer who completed a new or updated their Advanced Directive during the study period.

Secondary Outcome Measures

Comparison of Number of Women Who Report Appointment with Palliative Care
Count of number of women with ovarian cancer who report an appointment with a Palliative Care specialist

Full Information

First Posted
June 20, 2012
Last Updated
November 30, 2015
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01626014
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Usual Care Educational Website
Intervention Description
Using the control website: Participants access a website with standard ovarian cancer informational handouts.
Intervention Type
Behavioral
Intervention Name(s)
Prototype System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of Number of Women Who Completed Advanced Directive
Description
Count of number of women with ovarian cancer who completed a new or updated their Advanced Directive during the study period.
Time Frame
Day 60 After Baseline
Secondary Outcome Measure Information:
Title
Comparison of Number of Women Who Report Appointment with Palliative Care
Description
Count of number of women with ovarian cancer who report an appointment with a Palliative Care specialist
Time Frame
Day 60 After Baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa A. Geller, M.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Interactive Educational Website for Women With Ovarian Cancer & Caregivers

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