Breast Neoplasms
Conditions
Keywords
Women
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.
Interventions
BEHAVIORALProject Connect Online
Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family
BEHAVIORALPCO 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
Sponsors
Susan G. Komen Breast Cancer Foundation
Breast Cancer Research Foundation
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of general and cancer-related psychological status | Baseline, 2 months, 4 months | web site self reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in overall physical health status | Baseline, 2 months, 4 months | web site self reported |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed