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Interactive Educational Website for Women With Ovarian Cancer & Caregivers
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01626014
First received: June 20, 2012
Last updated: November 30, 2015
Last verified: November 2015
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Purpose
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.
| Condition | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 |
Resource links provided by NLM:
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Enrollment: | 53 |
| Study Start Date: | August 2012 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626014
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626014
Locations
| United States, Minnesota | |
| Masonic Cancer Center, University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
| Principal Investigator: | Melissa A. Geller, M.D. | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT01626014 History of Changes |
| Other Study ID Numbers: |
2012NTLS005 |
| Study First Received: | June 20, 2012 |
| Last Updated: | November 30, 2015 |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
Stage III ovarian cancer Stage IV ovarian cancer recurrent ovarian cancer primary peritoneal cancer fallopian tube cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases |
ClinicalTrials.gov processed this record on August 18, 2017