Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186524
Status:
COMPLETED
Last Update Posted:
2011-03-15
First Post:
2005-09-14
Brief Title:
Do Community Cancer Support Groups Reduce Physiological Stress in Women With Primary Breast Cancer
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 5050 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 Stanfords 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 SF 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 Stanfords 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
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 Stanfords 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 SF 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 Stanfords 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None