- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02866994
Project Connect Online: An Internet-based Intervention for Women With Breast Cancer (PCO)
September 29, 2020 updated by: Jonsson Comprehensive Cancer Center
Project Connect: Enhancing Connections During Metastatic Breast Cancer (PCO)
This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of women with metastatic breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women at least 18 years of age;
- first diagnosis of Stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis;
- ability to complete the intervention and assessments in English; and
- willingness to attend in-person PCO workshop;
Exclusion Criteria:
- male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses);
- local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and
- use of a personal website to post cancer-relevant material in the past six months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Project Connect Online (PCO)
Creation of personal website to share breast cancer experience with friends and family
|
Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family
|
Experimental: PCO PLUS
Creation of personal website to share breast cancer experience with friends and family, as well as other women diagnosed with breast cancer
|
Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family, as well as other women diagnosed with breast cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of general and cancer-related psychological status
Time Frame: Baseline, 2 months, 4 months
|
web site self reported
|
Baseline, 2 months, 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in overall physical health status
Time Frame: Baseline, 2 months, 4 months
|
web site self reported
|
Baseline, 2 months, 4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological mediator and moderator assessment
Time Frame: Baseline, 2 months, 4 months
|
phone and web based assessment: Comparative effectiveness of the two conditions will be evaluated with analysis of covariance (ANCOVA), in which the dependent variable is CES-D (Center for Epidemiologic Studies-Depression scale, condition assignment and any variables on which baseline imbalance is observed.
|
Baseline, 2 months, 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Patricia Ganz, MD, Proffessor and Director, Health Policy & Management
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2015
Primary Completion (Actual)
June 17, 2019
Study Completion (Actual)
June 17, 2019
Study Registration Dates
First Submitted
August 1, 2016
First Submitted That Met QC Criteria
August 10, 2016
First Posted (Estimate)
August 15, 2016
Study Record Updates
Last Update Posted (Actual)
October 1, 2020
Last Update Submitted That Met QC Criteria
September 29, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-001744
- 20155036 (Other Grant/Funding Number: Breast Cancer Research Foundation)
- SAC110009 (Other Identifier: Susan G. Komen Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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