Effects of Pet Therapy on Pain in Cancer Patients

NCT00431639 | Completed Phase 2

• 2 other identifiers: 05009305-CC-0093
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine how animal-assisted therapy (AAT) affects aspects of pain. It will explore the possible benefits of the National Institutes of Health's AAT program on distress in cancer patients receiving pain and palliative care at the NIH Clinical Center. A number of studies on the benefits of patients interacting with companion animals have shown a positive effect of both pet ownership and AAT for patients with chronic illness. However, few such experimental studies have been conducted with cancer patients. Patients 18 years of age and older who have been diagnosed with cancer and have been referred for consult with NIH's pain and palliative care team and recreation therapy may be eligible for this study. Participants have two study sessions, each lasting about 20 minutes on two different days. In one session, they visit with an animal assistant therapy dog and its handler. In the other session they engage in a conversation that the patient identifies as non-stressful. Patients are asked to fill out four forms before and after each session with questions and statements about their pain, attitude towards pets, symptoms they might be having, and demographic information, such as age, sex, marital status, and so forth. On four separate occasions, 1 teaspoon of blood is drawn and a swab of saliva is collected from the mouth up to an hour after the session.

Conditions

Cancer

Keywords

Animal-Assisted Therapy; Pain; Oncology; Cancer Pain

Outcome Measures

Primary Outcomes (1)

• Animal Assisted therapy on oncology patients being treated for pain

  Psychological and physiological distress is the primary outcome of interest in this study. This variable will be measured by two self report instruments, the Edmonton Symptom Assessment Scale and the Fear Visual Analog Scale, and two physiological assessments, salivary cortisol and serum beta endorphin. Several biochemical assays have been used as surrogate markers for stress. In this study, we propose to investigate two of these assays, serum beta-endorphin and salivary cortisol, in conjunction with other tools to assess levels of stress prior to, during and subsequent to treatment with animal-assisted therapy.

  72 hours

Study Arms (2)

Comparison

ACTIVE COMPARATOR

For the comparison condition, subjects will be asked to choose one of four topics that will be determined thatday with a recreational therapist for 20 minutes.

Behavioral: Animal Assisted Therapy

Treatment

ACTIVE COMPARATOR

The treatment condition will consist of a 20-minute visit by a therapy dog and its owner. Therapy dogowners will be instructed to limit conversation with the patient to topics of the therapy dog, thepatients pets, and pets in general.

Behavioral: Animal Assisted Therapy

Interventions

Animal Assisted Therapy BEHAVIORAL

Every subject will be exposed to both treatment and comparison conditions.

Comparison; Treatment

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Interruption of primary protocol
• Allergies to or fear of dogs
• Patient on strict contact, or respiratory isolation restrictions
• Neutropenic patients

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• Friedmann E, Thomas SA. Pet ownership, social support, and one-year survival after acute myocardial infarction in the Cardiac Arrhythmia Suppression Trial (CAST). Am J Cardiol. 1995 Dec 15;76(17):1213-7. doi: 10.1016/s0002-9149(99)80343-9.

  PMID: 7502998 BACKGROUND

• Barker SB, Pandurangi AK, Best AM. Effects of animal-assisted therapy on patients' anxiety, fear, and depression before ECT. J ECT. 2003 Mar;19(1):38-44. doi: 10.1097/00124509-200303000-00008.

  PMID: 12621276 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Pain; Cancer Pain

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ann M Cohen Berger, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 3, 2007
• First Posted: February 6, 2007
• Study Start: February 4, 2005
• Primary Completion: January 22, 2009
• Study Completion: December 21, 2018
• Last Updated: April 11, 2019

Record last verified: 2018-12-21

Locations

US (1)