CancerPhase 2NCT00431639
Effects of Pet Therapy on Pain in Cancer Patients
A Phase 2 study testing Animal Assisted Therapy in people with Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Cancer
- What is being tested?
- Animal Assisted Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2005to 21 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Interruption of primary protocol
- Allergies to or fear of dogs
- Patient on strict contact, or respiratory isolation restrictions
- Neutropenic patients
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Effect of Animal-Assisted Therapy on Distress in Oncology Patients Being Treated for Pain
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Animal Assisted Therapy
- Keywords
- Animal-Assisted Therapy, Pain, Oncology, Cancer Pain
- Medical subject headings
- Neoplasms, Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted TherapyBehavioural
Every subject will be exposed to both treatment and comparison conditions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Animal Assisted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2007 (estimated)
- Study start4 Feb 2005
- Primary completion22 Jan 2009
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ann M Cohen Berger, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431639
- Sponsor's protocol ID
- 050093
- Other IDs
- 05-CC-0093
- Status last verified
- 21 Dec 2018
- First submitted
- 3 Feb 2007
- Last updated
- 11 Apr 2019
- Results posted
- No
Publications
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.
PubMed 7502998Barker 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.
PubMed 12621276
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animal-Assisted Therapy on Distress in Oncology Patients Being Treated for Pain
- ClinicalTrials.gov ID
- NCT00431639
- Acronym / sponsor ID
- 050093
- Conditions
- Cancer
- Keywords
- Animal-Assisted Therapy, Pain, Oncology, Cancer Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 4 Feb 2005
- Primary completion
- 22 Jan 2009 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 6 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison | Active comparator | Behavioral: Animal Assisted TherapyFor 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. |
| Treatment | Active comparator | Behavioral: Animal Assisted TherapyThe 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Interruption of primary protocol
- Allergies to or fear of dogs
- Patient on strict contact, or respiratory isolation restrictions
- Neutropenic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal Assisted TherapyEvery subject will be exposed to both treatment and comparison conditions. | Behavioural | Comparison, Treatment |
Primary outcome
Animal Assisted therapy on oncology patients being treated for pain
Time frame: 72 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Background: PubMed 7502998Friedmann 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.
- Background: PubMed 12621276Barker 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.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Cohen Berger, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Animal Assisted Therapy in people with Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Animal Assisted therapy on oncology patients being treated for pain (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00431639, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.