Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034034
Status:
COMPLETED
Last Update Posted:
2007-01-05
First Post:
2002-04-19
Brief Title:
Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
An Intervention to Improve End-of-Life Symptom Distress
Status:
COMPLETED
Status Verified Date:
2007-01
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 study investigates the effect of acupuncture in reducing symptom distress in adults with advanced colon cancer
Detailed Description:
End-stage colorectal cancer is associated with physical and psychological symptoms that negatively affect patients quality of life QOL Nonpharmacological interventions that promote relaxation and reduce psychological distress are associated with a reduction of pain suggesting that psychological distress and anxiety may mediate the relationship between symptom severity and QOL Pilot data from a sample of 28 end-stage cancer patients supports the mediational role of psychological distress in the symptom severity - QOL relationship The results indicated that the mere presence or absence of a physical symptom is not related to patient QOL Rather greater symptom severity was associated with significantly poorer QOL and when the effects of psychological distress were controlled the relationships between symptom severity and QOL were no longer significant The proposed research focuses on psychological distress as an underlying mechanism of physical symptom severity among EOL cancer patients and a non-traditional approach acupuncture to relieving distress and symptom severity Acupuncture has been used successfully with end-of-life populations EOL to reduce pain and shortness of breath 4 Patients with psychological distress report the greatest benefit from acupuncture Rather than using acupuncture to treat pain and discomfort the proposed research will evaluate acupuncture that targets acupoints associated with anxiety and emotional well-being One hundred seventy patients with metastatic colorectal cancer will be recruited for the study through the University of Pittsburgh Cancer Institute UPCI
Participating patients will be randomized into one of three conditions 1 a true acupuncture condition 2 a sham acupuncture condition and 3 a usual care control group Assessment procedures will gather demographic QOL physical and psychological symptomatology medication use and salivary cortisol data Randomization will occur after baseline assessment and participants randomized to one of the two intervention conditions will receive acupuncture treatments three times a week for four weeks Follow-up assessments will occur weekly for four weeks following the intervention The proposed study will 1 test the efficacy of an acupuncture intervention in reducing psychological distress and physical symptom severity and 2 examine acupunctures role in regulating stress responses associated with hypothalamic-pituitary axis HPA activity Findings from this study will 1 promote our understanding of psychological distress as a mechanism of physical symptom distress and 2 promote the integration of Eastern healing philosophies acupuncture with the Western medical model stress-related HPA activation
Participating patients will be randomized into one of three conditions 1 a true acupuncture condition 2 a sham acupuncture condition and 3 a usual care control group Assessment procedures will gather demographic QOL physical and psychological symptomatology medication use and salivary cortisol data Randomization will occur after baseline assessment and participants randomized to one of the two intervention conditions will receive acupuncture treatments three times a week for four weeks Follow-up assessments will occur weekly for four weeks following the intervention The proposed study will 1 test the efficacy of an acupuncture intervention in reducing psychological distress and physical symptom severity and 2 examine acupunctures role in regulating stress responses associated with hypothalamic-pituitary axis HPA activity Findings from this study will 1 promote our understanding of psychological distress as a mechanism of physical symptom distress and 2 promote the integration of Eastern healing philosophies acupuncture with the Western medical model stress-related HPA activation
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