NCT01626014

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2012

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.3 years

First QC Date

June 20, 2012

Last Update Submit

November 30, 2015

Conditions

Stage III Ovarian CancerStage IV Ovarian CancerRecurrent Ovarian CancerFallopian Tube Cancer

Keywords

Stage III ovarian cancerStage IV ovarian cancerrecurrent ovarian cancerprimary peritoneal cancerfallopian tube cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 60 After Baseline

Secondary Outcomes (1)

  • Comparison of Number of Women Who Report Appointment with Palliative Care

    Day 60 After Baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Usual Care Educational WebsiteBEHAVIORAL

Using the control website: Participants access a website with standard ovarian cancer informational handouts.

Control Group
Prototype SystemBEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with Stage III, IV or recurrent ovarian, primary peritoneal or fallopian tube cancer or a nominated caregiver or such women
  • 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)

You may not qualify if:

  • Borderline ovarian cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Melissa A. Geller, M.D.

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 22, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(1)