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

Breast Neoplasms Clinical Trial

— PCO  

Official title:

Project Connect: Enhancing Connections During Metastatic Breast Cancer (PCO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866994
• Other study ID #: 14-001744
• Secondary ID: 20155036SAC11000
• Status: Completed
• Phase: N/A
• Start date: June 4, 2015
• Est. completion date: June 17, 2019

Study information

• Verified date: April 2020
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• Project Connect Online
Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family
• 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

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Breast Cancer Research Foundation, Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychological mediator and moderator assessment	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
Primary	Change of general and cancer-related psychological status	web site self reported	Baseline, 2 months, 4 months
Secondary	Change in overall physical health status	web site self reported	Baseline, 2 months, 4 months