Interactive Educational Website for Women With Ovarian Cancer & Caregivers

Study Description

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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.

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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	53 participants
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
Study Start Date :	August 2012
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	December 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT01626014 History of Changes
Other Study ID Numbers:	2012NTLS005
First Posted:	June 22, 2012
Last Update Posted:	December 2, 2015
Last Verified:	November 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