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NCT00431639 · ClinicalTrials.gov registry record · Phase 2
Effects of Pet Therapy on Pain in Cancer Patients
A Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00431639: Completed Phase 2 study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00431639 is a Phase 2 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00431639, a Phase 2 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- BEHAVIORAL Animal Assisted Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2005-02-04 |
| Est. Completion | 2018-12-21 |
| Phase | Phase 2 |
What the finished NCT00431639 record still lists
NCT00431639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Animal Assisted Therapy is the first listed.
NCT00431639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00431639 about?
NCT00431639 is a clinical study titled "Effects of Pet Therapy on Pain in Cancer Patients". 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 benefit...
What is the current status of trial NCT00431639?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2005-02-04. Estimated completion is 2018-12-21.
What interventions are being tested in trial NCT00431639?
The interventions under investigation include: Animal Assisted Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT00431639?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00431639's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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