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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT02866994
Collaborator
Susan G. Komen Breast Cancer Foundation (Other), Breast Cancer Research Foundation (Other)
33
Enrollment
1
Location
2
Arms
48.4
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Behavioral: Project Connect Online
  • Behavioral: PCO PLUS
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
33 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 :
Jun 4, 2015
Actual Primary Completion Date :
Jun 17, 2019
Actual Study Completion Date :
Jun 17, 2019

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. Change of general and cancer-related psychological status [Baseline, 2 months, 4 months]

    web site self reported

Secondary Outcome Measures

  1. Change in overall physical health status [Baseline, 2 months, 4 months]

    web site self reported

Other Outcome Measures

  1. Psychological mediator and moderator assessment [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1University of California, Los AngelesLos AngelesCaliforniaUnited States90095

Sponsors and Collaborators

  • Jonsson Comprehensive Cancer Center
  • Susan G. Komen Breast Cancer Foundation
  • Breast Cancer Research Foundation

Investigators

  • Principal Investigator: Patricia Ganz, MD, Proffessor and Director, Health Policy & Management

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02866994
Other Study ID Numbers:
  • 14-001744
  • 20155036
  • SAC110009
First Posted:
Aug 15, 2016
Last Update Posted:
Oct 1, 2020
Last Verified:
Apr 1, 2020
Keywords provided by Jonsson Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2020