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The Effect of Animal-Assisted Therapy on Distress in Oncology Patients Being Treated for Pain

Phase 3
18 Years
Not Enrolling
Pain, Cancer

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Trial Information

The Effect of Animal-Assisted Therapy on Distress in Oncology Patients Being Treated for Pain

The purpose of this study is to evaluate the effectiveness of the NIH Animal-Assisted
Therapy (AAT) program on distress in oncology patients treated for pain. More than simply a
physiologic or sensory response, pain is multidimensional. Pain management programs are
best developed by selecting interventions based on the individual's pain experience.
Strategies with several courses of action that complement each other may be selected to work
together in a synergistic response to maximize pain relief. The goal of palliative care is
to achieve the highest possible quality of life for patients, and indirectly, their
families, through symptom control and attention to the whole patient: addressing physical,
psychosocial, and emotional dimensions.

Limited research with persons receiving palliative care for cancer indicates that a variety
of complementary interventions can mitigate psychological distress and improve quality of
life (Ernst, 2001). A growing body of literature documenting positive effects of pet
ownership and animal-assisted therapy (AAT) on patients with chronic illnesses warrants
consideration of this type of intervention among the complementary approaches that may
benefit terminally ill cancer patients.

The purpose of the proposed preliminary study is to explore the possible benefits of the
existing NIH AAT program on psychological and physiological distress in cancer patients
referred for pain and palliative care consults at the NIH Clinical Center. The primary
outcome variable of interest is distress. Secondary outcomes of interest are pain
intensity, pain unpleasantness, and use of pain medications. Attitudes towards pets is
considered a moderating variable and will also be assessed.

A pre-post, within-subjects design will be used. Patients will be assigned in randomized
block order to a comparison and treatment condition, administered at the same time of day on
two consecutive days. The treatment condition is 20 minutes of AAT and the comparison
condition is a 20-minute neutral discussion with a Recreational Therapist. All participants
will be adult oncology patients consulted to the pain and palliative care service, and
recreation therapy.

Psychological data will be collected pre and post session by survey instruments; medication
use will be collected every 24 hours; physiological stress will be measured by salivary
cortisol and, for patients with established indwelling catheters only, serum beta-endorphin

Repeated measures ANOVA will be used to assess the effect of the two conditions (treatment
vs. comparison) on each of the dependent variables. Descriptive statistics will be used to
summarize baseline demographics.

Inclusion Criteria


All adult cancer patients enrolled in research protocols who have a pain and palliative
care consult, or a recreation therapy consult at the NIH Clinical Center may be eligible
for the current study. Since the AAT provided at the NIH Clinical Center is generally
available to the heterogeneous cancer population (with the exception of neutropenic
patients) and the primary outcome of interest is distress regardless of the type of
cancer, a heterogenous sample of cancer patients is considered appropriate for this
investigation. While adults are the target population for this pilot study, if results
are encouraging, minors will be considered for inclusion in subsequent studies.


- Ability to speak English and read at a 5th grade level

- 18 years of age or older

- Able to give informed consent

- Consulted to pain and palliative care team and Recreation Therapy

- Diagnosis of cancer

Available to be at the CRC on two consecutive days in the morning hours.


- Interruption of primary protocol

- Allergies to or fear of dogs

- Patient on strict contact, or respiratory isolation restrictions

- Neutropenic patients

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Ann M Berger, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)


United States: Federal Government

Study ID:




Start Date:

February 2005

Completion Date:

January 2009

Related Keywords:

  • Pain
  • Cancer
  • Cancer Pain
  • Animal-Assisted Therapy
  • Recreation Therapy



National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892