Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273208
Status:
COMPLETED
Last Update Posted:
2007-08-02
First Post:
2006-01-05
Brief Title:
An Intervention to Decrease Fatigue Among Breast Cancer Survivors
Sponsor:
Mercy Medical Center
Organization:
Mercy Medical Center
Study Overview
Official Title:
Being Well Staying Healthy An Integrated Mind-Body Medicine Intervention to Decrease Fatigue Among Breast Cancer Survivors PILOT STUDY
Status:
COMPLETED
Status Verified Date:
2007-08
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:
This research project is being done to design and then test whether a 10 week program can help reduce the symptoms of being tired and fatigued among women who have had breast cancer The pilot study will include 4 groups of women two groups of women from Baltimore and two groups of women from Washington County Maryland Each group will have 5 to 6 women The purpose of this pilot study is to help us find the best things to include in the program to help women who have had breast cancer and who have severe problems with fatigue that has lasted months to years after being treated with chemotherapy or radiation therapy
Following the pilot program we will conduct and evaluate using a quasi-experimental design comparing fatigue scores before and after the intervention the efficacy of the refined 10-week integrated mindbody medicine approach to reduce symptoms of fatigue among breast cancer survivors who have completed their adjuvant therapy Four intervention groups 12 women per group will be conducted two in the urban setting and two in the rural setting We will assess fatigue symptoms at baseline immediately after the program 2 months and 6 months following completion of the program We will compare mean baseline scores to post-intervention scores
The ultimate goal is to develop a non-pharmacologic holistic low risk intervention for improving symptoms of fatigue and thus improving quality of life among breast cancer survivors
Following the pilot program we will conduct and evaluate using a quasi-experimental design comparing fatigue scores before and after the intervention the efficacy of the refined 10-week integrated mindbody medicine approach to reduce symptoms of fatigue among breast cancer survivors who have completed their adjuvant therapy Four intervention groups 12 women per group will be conducted two in the urban setting and two in the rural setting We will assess fatigue symptoms at baseline immediately after the program 2 months and 6 months following completion of the program We will compare mean baseline scores to post-intervention scores
The ultimate goal is to develop a non-pharmacologic holistic low risk intervention for improving symptoms of fatigue and thus improving quality of life among breast cancer survivors
Detailed Description:
Research Question
Fatigue is a common persistent symptom following treatment for breast cancer challenging a womens ability to promptly regain her overall health and well-being The aim of the study is to design evaluate and implement an integrated mind-body medicine intervention to reduce symptoms of persistent fatigue
The research questions being addressed are Can a 10 week mind-body medicine intervention program improve fatigue scores from the disability range to the non-disabled range and does the improvement in fatigue symptoms persist up to 6 months following the intervention
The aims of the study are to Aim I Pilot test a 10 week mindbody medicine group intervention among 4 groups of breast cancer survivors with 5 women per group Groups will be stratified by urbanrural setting Baltimore regionWashington County race African American and White and educational status These pilot groups will evaluate the program to help refine the intervention to be comprehensible and culturally sensitive
Aim II A 10-week intervention program will be developed specifically targeted to alleviate fatigue among breast cancer survivors Weekly sessions of approximately 2 hours duration will be held Four intervention groups with approximatley 12 women per group women will be conducted in two regions an urban setting and a rural setting The interventions will be conducted at the Womens Center for Health Medicine at the Mercy Medical Center in downtown Baltimore and the Robinwood Outpatient Medical Facility in Hagerstown Maryland Washington County The Womens center is located downtown Baltimore with access to public transportation as well as a having convenient parking with valet services The Robinwood Center is also centrally located in Washington County near Hagerstown MD
Rationale
Thirty-five percent of breast cancer survivors between 1 and 5 years following the diagnosis of breast cancer report symptoms of fatigue that fall into the disability range despite remaining disease-free Bower 2000 Lindley 1998 There is a paucity of information on what interventions may be most useful in reducing fatigue symptoms Most interventions have focused on one factor that may contribute to fatigue such as sleep disturbance or pain Exercise interventions have been tried but have mostly focused on fatigue during chemotherapy or radiation therapy and have not addressed the problem of persistent fatigue
Fatigue is a complex multi-dimensional symptom with several contributing factors Pain sleep disturbance depression decreased physical activity and menopausal symptoms are associated with fatigue Couzi 1995 Servaes 2002 Bennett 2004 and Bower 2000 Therefore a broad-based intervention program holds the most promise for alleviating fatigue We propose to examine the efficacy of a holistic mindbody medicine approach to empower women to address many of the factors associated with fatigue and incorporate healthy behaviors into their routine to alleviate fatigue The intervention is a 10 week program modeled after the MindBody Medicine program established by Dr Herbert Benson of the Harvard-affliliated Mind Body Medicine Institute
Methods Study Design Quasi-experimental beforeafter study design
Population The target population is women with breast cancer diagnosed within the past 5 years The eligibility criteria include
Women within 5 years of the diagnosis of breast cancer and currently disease free
Women must have completed chemotherapy andor radiation therapy 6 months prior to joining the study
Women may be taking adjuvant hormonal therapy eg tamoxifen or aromatase inhibitors
Women scoring less than 50 consistent with servere fatigue leading to disability and limitations on the energyfatigue subscale of the SF-36 health survey Appendix A
Intervention
Each session will last approximately 90 minutes We will offer the sessions at the most convenient time for participants eg early morning lunch time or evening The time will be established based on availability of the participants
Sample Size
The pilot study will recruit 5 women for each of 4 groups Two urban groups African American and White and two rural groups stratified by educational status less than high school high school graduate and higher No formal sample size was calculated for the pilot study The women will evaluate each session for comprehension and relevance to their situation eg exercise interventions may vary significantly for an urban resident versus a rural resident Following the completion of the 10 week program we will also ask each woman to evaluate the program as a whole
Sample size calculations for the main intervention component were based on results of a survey of fatigue and quality of life among breast cancer survivors 1 to 5 years following the diagnosis of breast Bower 2000 That study used the energyfatigue subscale of the SF-36 Health Survey Ware 1992 That instrument has also been shown to correlate with the Piper fatigue scale an instrument specifically designed and evaluated among breast cancer patients Piper 1998 We will administer both survey instruments but will base sample size estimates on the SF-36 a more widely used health survey instrument
The SF-36 energyfatigue subscale defines disabilitylimitation as scores under 50 In a survey of breast cancer survivors women classified as disabled due to fatigue scoring less than 50 on the subscale had a mean score of 37 Bower 2000 Overall in that study breast cancer survivors had a mean score of 60 standard deviation 20 Women who fall into the disabled range of the energyfatigue subscale will be recruited for this study We estimate that the intervention will improve mean scores to a level of 5051 average 14 point improvement to the non-disabled range We will compare mean scores before and after the intervention session Assuming a mean score of 37 and a projected mean score improvement of 14 points 10 women per intervention group will give a power of 80 to detect a mean difference of 14 points using paired-t-test We will recruit 12 patients per group allowing for potential dropouts during the intervention Thus each of 4 groups of women should provide adequate power to detect a meaningful clinical improvement in fatigue scores
Recruitment
Women will be recruited through the Hoffberger Breast Center the Medical Oncology Practice at Mercy and for Washington County through the John Marsh Cancer Center
Fatigue is a common persistent symptom following treatment for breast cancer challenging a womens ability to promptly regain her overall health and well-being The aim of the study is to design evaluate and implement an integrated mind-body medicine intervention to reduce symptoms of persistent fatigue
The research questions being addressed are Can a 10 week mind-body medicine intervention program improve fatigue scores from the disability range to the non-disabled range and does the improvement in fatigue symptoms persist up to 6 months following the intervention
The aims of the study are to Aim I Pilot test a 10 week mindbody medicine group intervention among 4 groups of breast cancer survivors with 5 women per group Groups will be stratified by urbanrural setting Baltimore regionWashington County race African American and White and educational status These pilot groups will evaluate the program to help refine the intervention to be comprehensible and culturally sensitive
Aim II A 10-week intervention program will be developed specifically targeted to alleviate fatigue among breast cancer survivors Weekly sessions of approximately 2 hours duration will be held Four intervention groups with approximatley 12 women per group women will be conducted in two regions an urban setting and a rural setting The interventions will be conducted at the Womens Center for Health Medicine at the Mercy Medical Center in downtown Baltimore and the Robinwood Outpatient Medical Facility in Hagerstown Maryland Washington County The Womens center is located downtown Baltimore with access to public transportation as well as a having convenient parking with valet services The Robinwood Center is also centrally located in Washington County near Hagerstown MD
Rationale
Thirty-five percent of breast cancer survivors between 1 and 5 years following the diagnosis of breast cancer report symptoms of fatigue that fall into the disability range despite remaining disease-free Bower 2000 Lindley 1998 There is a paucity of information on what interventions may be most useful in reducing fatigue symptoms Most interventions have focused on one factor that may contribute to fatigue such as sleep disturbance or pain Exercise interventions have been tried but have mostly focused on fatigue during chemotherapy or radiation therapy and have not addressed the problem of persistent fatigue
Fatigue is a complex multi-dimensional symptom with several contributing factors Pain sleep disturbance depression decreased physical activity and menopausal symptoms are associated with fatigue Couzi 1995 Servaes 2002 Bennett 2004 and Bower 2000 Therefore a broad-based intervention program holds the most promise for alleviating fatigue We propose to examine the efficacy of a holistic mindbody medicine approach to empower women to address many of the factors associated with fatigue and incorporate healthy behaviors into their routine to alleviate fatigue The intervention is a 10 week program modeled after the MindBody Medicine program established by Dr Herbert Benson of the Harvard-affliliated Mind Body Medicine Institute
Methods Study Design Quasi-experimental beforeafter study design
Population The target population is women with breast cancer diagnosed within the past 5 years The eligibility criteria include
Women within 5 years of the diagnosis of breast cancer and currently disease free
Women must have completed chemotherapy andor radiation therapy 6 months prior to joining the study
Women may be taking adjuvant hormonal therapy eg tamoxifen or aromatase inhibitors
Women scoring less than 50 consistent with servere fatigue leading to disability and limitations on the energyfatigue subscale of the SF-36 health survey Appendix A
Intervention
Each session will last approximately 90 minutes We will offer the sessions at the most convenient time for participants eg early morning lunch time or evening The time will be established based on availability of the participants
Sample Size
The pilot study will recruit 5 women for each of 4 groups Two urban groups African American and White and two rural groups stratified by educational status less than high school high school graduate and higher No formal sample size was calculated for the pilot study The women will evaluate each session for comprehension and relevance to their situation eg exercise interventions may vary significantly for an urban resident versus a rural resident Following the completion of the 10 week program we will also ask each woman to evaluate the program as a whole
Sample size calculations for the main intervention component were based on results of a survey of fatigue and quality of life among breast cancer survivors 1 to 5 years following the diagnosis of breast Bower 2000 That study used the energyfatigue subscale of the SF-36 Health Survey Ware 1992 That instrument has also been shown to correlate with the Piper fatigue scale an instrument specifically designed and evaluated among breast cancer patients Piper 1998 We will administer both survey instruments but will base sample size estimates on the SF-36 a more widely used health survey instrument
The SF-36 energyfatigue subscale defines disabilitylimitation as scores under 50 In a survey of breast cancer survivors women classified as disabled due to fatigue scoring less than 50 on the subscale had a mean score of 37 Bower 2000 Overall in that study breast cancer survivors had a mean score of 60 standard deviation 20 Women who fall into the disabled range of the energyfatigue subscale will be recruited for this study We estimate that the intervention will improve mean scores to a level of 5051 average 14 point improvement to the non-disabled range We will compare mean scores before and after the intervention session Assuming a mean score of 37 and a projected mean score improvement of 14 points 10 women per intervention group will give a power of 80 to detect a mean difference of 14 points using paired-t-test We will recruit 12 patients per group allowing for potential dropouts during the intervention Thus each of 4 groups of women should provide adequate power to detect a meaningful clinical improvement in fatigue scores
Recruitment
Women will be recruited through the Hoffberger Breast Center the Medical Oncology Practice at Mercy and for Washington County through the John Marsh Cancer Center
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