Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer

Study Overview
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Brief Summary
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This study investigates the effect of acupuncture in reducing symptom distress in adults with advanced colon cancer.

Detailed Description
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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 acupuncture's 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).

Official Title
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An Intervention to Improve End-of-Life Symptom Distress

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Advanced colon cancer that has not responded to two rounds of chemotherapy Speak, read, write English Live within a 50 mile radius of Pittsburgh, PA Not taking any steroid medication A platelet count of 75,000 or greater Never had acupuncture before Exclusion Criteria: Allergy to stainless steal Implanted pacemaker Current skin infection Needle phobia Metastatic disease to the central nervous system (brain, spinal cord)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acupuncture|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced colorectal cancer, acupressure /acupuncture, anxiety, colorectal neoplasm, human therapy evaluation, neoplasm /cancer palliative treatment, quality of life, terminal patient care, hypothalamic pituitary adrenal axis, pain, psychological aspect of cancer, stress management, alternative medicine, behavioral /social science research tag, human subject, patient oriented research