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Project Connect Online: An Internet-based Intervention for Women With Breast Cancer (PCO)

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ClinicalTrials.gov Identifier: NCT02866994
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Breast Cancer Research Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: Project Connect Online Behavioral: PCO PLUS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Project Connect: Enhancing Connections During Metastatic Breast Cancer (PCO)
Actual Study Start Date : June 4, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change of general and cancer-related psychological status [ Time Frame: Baseline, 2 months, 4 months ]
    web site self reported


Secondary Outcome Measures :
  1. Change in overall physical health status [ Time Frame: Baseline, 2 months, 4 months ]
    web site self reported


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866994


Contacts
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Contact: Annette L Stanton, PhD 3108253105 astanton@ucla.edu
Contact: Lauren Harris, MA 3107944911 lhanover@ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Anette Stanton, PhD    310-825-3105    astanton@ucla.edu   
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Susan G. Komen Breast Cancer Foundation
Breast Cancer Research Foundation
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Patricia Ganz, MD Proffessor and Director, Health Policy & Management
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02866994     History of Changes
Other Study ID Numbers: 14-001744
20155036 ( Other Grant/Funding Number: Breast Cancer Research Foundation )
SAC110009 ( Other Grant/Funding Number: Susan G. Komen Breast Cancer Foundation )
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Jonsson Comprehensive Cancer Center:
Women
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases