NCT Number: NCT00186524
Do Community Cancer Support Groups Reduce Physiological Stress in Women With Primary Breast Cancer?
Women with primary breast cancer may benefit from participating in supports groups as they cope with treatment and the psychological challenges of survivorship. Studies have documented that these women benefit from support groups run in a university setting; however, no one has documented that they benefit from community cancer support groups. Many community cancer support groups exist and provide service to a large number of women with breast cancer. It is important to know if these groups are providing comparable service to well researched support groups. We conducted this study as the first randomized study of community compared to university-style support groups. Women had a 50/50 chance of being assigned to either a community or a university style support group based on a coin flip. This study took place in two sites The Wellness Community East Bay (Walnut Creek) and San Francisco. Two community groups were studied.
i) This study evaluated the strengths and weaknesses of two community-based support group interventions for breast cancer patients [The Wellness (TWC) and Cancer Support (CSC) Communities, in the San Francisco area]. We compared them with a type of therapy developed in the university setting (Stanford's Supportive-Expressive group therapy), studied which aspects are most effective, and who benefits the most. We compared these women on change in emotional distress, means of coping with cancer, and social and family support. In addition, change in physiological response to stress was measured using saliva samples.
ii) We were able to achieve recruitment for 6 of 8 groups proposed. We randomized 72 women in blocks of 12 taking consecutive women per site until we accrued 12 for each group. Of those, 61 women actually attended groups, of those 46 women to date completed at least one follow-up and were available for analysis for this report. We screened 108 women, 16 who were screened out on initial phone contact, 20 women began to go through our baseline interviews and assessments and either decided not to enroll or dropped out before we could compose a group for the second S.F. randomization. Our final two follow-up assessments for our final group in the East Bay are being conducted right now (8 month) and will be conducted in October, 2002 (12 month) so they are not available for assay or analysis for this final report.
iii) We examined 5 outcome variables for this report and found that women participating in the community groups changed at about the same level over the 4 months of group therapy as the women in the Stanford groups. This was true for depression symptoms, trauma symptoms, social support, self-efficacy, and post-traumatic-growth. These analyses are preliminary until we complete our final follow-up assessments. It is encouraging for the community groups that women benefited at the same rate as they did in the well-researched Stanford groups. Conclusions for this study are somewhat limited because we could not complete the recruitment of our entire sample. However, there is every reason to suppose that community groups are as effective at serving women with primary breast cancer as Stanford's groups though they are based on very different ideas of therapy. It is important to note that all of these groups were led by therapists, and that we may have found other results if the groups had been led by peers or other types of professionals. This study reduces the human and economic cost of breast cancer in California by validating community groups usually offered free to women with breast cancer.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
Cancer Support Community, San Francisco, California, United States
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- be > 18 years old
- be diagnosed with primary breast cancer (Stages I-III, without metastasis or recurrence) within the past 5 years
- be able to read, speak, and understand English;
- be < 18 months post treatment; -
Exclusion criteria
participation in more than 8 sessions of a support group.
-
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Stanford University
Other
Collaborators
- California Breast Cancer Research Program
- The Dana Foundation
- The Wellness Community
Registry information
Important dates
- First posted
- Sep 16, 2005
- Registry last updated
- Mar 15, 2011
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Tumor-Derived FGF19
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsAfrican Cancer Genome: GMD
NCT05754658
Breast Cancer, Breast Diseases
Philadelphia, Pennsylvania, United States
View Trial Details24GUT540 : Meeting of Breast Cancer Patients and Pathologists
NCT07040514
Breast Cancer, Breast Diseases
Lebanon, New Hampshire, United States
View Trial DetailsNeoadjuvant Pembrolizumab and Carboplatin Plus Paclitaxel for Stage I Triple-negative Breast Cancer
NCT06604858
Breast Cancer, Breast Diseases
A Coruña, Spain
View Trial Details