Effects of Pet Therapy on Pain in Cancer Patients
Condition: Cancer
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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
      levels.

      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.
    

Intervention name(s): Animal Assisted Therapy
Intervention type(s): Behavioral
Intervention description(s): Every subject will be exposed to both treatment and comparison conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Animal-Assisted Therapy; Pain; Oncology; Cancer Pain