Animal-Assisted Therapy and Recreation Therapy in Relieving Distress in Cancer Patients Undergoing Treatment for Pain - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00103688

Purpose

RATIONALE: Animal-assisted therapy and recreation therapy may help relieve mental and physical distress in cancer patients being treated for pain and help them live more comfortably.

PURPOSE: This randomized clinical trial is studying how well animal-assisted therapy and recreation therapy works in relieving distress in cancer patients undergoing treatment for pain.

Condition	Intervention
Pain Psychosocial Effects of Cancer and Its Treatment Unspecified Adult Solid Tumor, Protocol Specific	Other: laboratory biomarker analysis Procedure: animal-assisted therapy Procedure: pain therapy Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Supportive Care
Official Title:	The Effect of Animal-Assisted Therapy on Distress in Oncology Patients Being Treated for Pain

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Psychological and physiological distress as measured by the Edmonton Symptom Assessment Scale and the Fear Visual Analog Scale before and after each intervention

Secondary Outcome Measures:

Pain intensity and unpleasantness as measured by the Descriptor Differential Scale before and after each intervention
Use (dose and time of administration) of PRN pain medications as measured every 24 hours
Attitudes toward pets as measured by the Pet Attitude Scale before and after each intervention

Estimated Enrollment:	150
Study Start Date:	December 2006
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the effect of animal-assisted therapy and recreational therapy on psychological and physiological distress in oncology patients being treated for pain.

Secondary

Determine the effect of these therapies on the level of pain unpleasantness and the use of PRN pain medications in these patients.
Determine the effect of these therapies on the level of pain intensity in these patients.
Determine the effect of these therapies on patient attitudes towards pets.

OUTLINE: This is a randomized, cross-over study. Patients are randomized to 1 of 2 arms.

Arm I: Patients undergo a 20-minute animal-assisted therapy (AAT) session with an AAT dog and dog owner on day 1 followed by a 20-minute session with a recreational therapist on day 2.
Arm II: Patients undergo a 20-minute session with a recreational therapist on day 1 followed by a 20-minute AAT session with a dog and dog owner on day 2.

Patients in both arms complete two questionnaires before and after each therapy session to measure physiological and psychological distress related to pain. Patients also undergo measurement of pain-related physiological distress by assessment of salivary cortisol. For patients with indwelling catheters, serum beta-endorphin levels are measured as markers of distress. Medication use data are collected every 24 hours during study.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of cancer
Currently enrolled in a primary research protocol and referred for consult to the National Institute of Health's pain and palliative care team and/or recreation therapy
- Participation in this study is contingent upon approval of principal investigator of primary protocol
  - Participation in this study may not interrupt or alter primary cancer therapy
Rating of ≥ 4 on the distress scale and/or 6 yes boxes checked

PATIENT CHARACTERISTICS:

Able to speak English and read at a 5th-grade level
No allergies to or fear of dogs
No strict contact or respiratory isolation restrictions
No neutropenia

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103688

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Ann Berger, MD, MSN

NIH - Warren Grant Magnuson Clinical Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00103688 History of Changes
Obsolete Identifiers:	NCT00431639
Other Study ID Numbers:	CDR0000529950, NCI-05-CC-0093
Study First Received:	February 11, 2005
Last Updated:	July 20, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
pain

ClinicalTrials.gov processed this record on February 09, 2012