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

NCT ID: NCT02866994

Last Updated: 2020-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-04

Study Completion Date

2019-06-17

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Project Connect Online (PCO)

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

Group Type EXPERIMENTAL

Project Connect Online

Intervention Type BEHAVIORAL

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

PCO PLUS

Creation of personal website to share breast cancer experience with friends and family, as well as other women diagnosed with breast cancer

Group Type EXPERIMENTAL

PCO PLUS

Intervention Type 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

Interventions

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Project Connect Online

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Susan G. Komen Breast Cancer Foundation

OTHER

Sponsor Role collaborator

Breast Cancer Research Foundation

OTHER

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Ganz, MD

Role: PRINCIPAL_INVESTIGATOR

Proffessor and Director, Health Policy & Management

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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20155036

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SAC110009

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

14-001744

Identifier Type: -

Identifier Source: org_study_id

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