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

NCT02866994 | Completed

• 3 other identifiers: 14-00174420155036SAC110009
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Women

Outcome Measures

Primary Outcomes (1)

• Change of general and cancer-related psychological status

  web site self reported

  Baseline, 2 months, 4 months

Secondary Outcomes (1)

• Change in overall physical health status

  Baseline, 2 months, 4 months

Other Outcomes (1)

• Psychological mediator and moderator assessment

  Baseline, 2 months, 4 months

Study Arms (2)

Project Connect Online (PCO)

EXPERIMENTAL

Creation of personal website to share breast cancer experience with friends and family

Behavioral: Project Connect Online

PCO PLUS

EXPERIMENTAL

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

Interventions

Project Connect Online BEHAVIORAL

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

Project Connect Online (PCO)

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

PCO PLUS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Patricia Ganz, MD

  Proffessor and Director, Health Policy & Management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 15, 2016
• Study Start: June 4, 2015
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: October 1, 2020

Record last verified: 2020-04

Locations

US (1)