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Completed

NCT Number: NCT02866994

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project Connect Online

Behavioral

Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family

PCO PLUS

Behavioral

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

Primary outcomes

  1. Change of general and cancer-related psychological status

    Time frame: Baseline, 2 months, 4 months

    web site self reported

Secondary outcomes

  1. Change in overall physical health status

    Time frame: Baseline, 2 months, 4 months

    web site self reported

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Breast Cancer Research Foundation
  • Susan G. Komen Breast Cancer Foundation

Registry information

Official study title

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

Acronym: PCO

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2016
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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