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An Intervention to Improve End-of-Life Symptom Distress

Phase 1
18 Years
Not Enrolling
Colorectal Neoplasms

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Trial Information

An Intervention to Improve End-of-Life Symptom Distress

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).

Inclusion Criteria

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Principal Investigator

Ellen Redinbaugh, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:

R01 AT001028-01



Start Date:

June 2002

Completion Date:

August 2006

Related Keywords:

  • Colorectal Neoplasms
  • 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
  • Neoplasms
  • Colorectal Neoplasms



University of Pittsburgh Medical Center, Cancer Institute Pittsburgh, Pennsylvania  15213