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

  • United States
    • 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
Behavioral: Project Connect Online
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
Behavioral: PCO PLUS
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.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Susan G. Komen Breast Cancer Foundation
Breast Cancer Research Foundation

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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