Therapy-Associated CancerNCT06280612
The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients
A study testing Pet therapy in people with Therapy-Associated Cancer and Cancer Patient, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapy-Associated Cancer, Cancer Patient, Happiness
- What is being tested?
- Pet therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Sep 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria for admission to the study are 18≤ of age,
- Agreeing to participate in the research,
- Being conscious of receiving outpatient chemotherapy treatment for 3≤ months, and being able to communicate.
- The criteria included no impairment in mental and cognitive functions of patients/relatives in the live group,
- Patients in the live cat group not having any animal allergies, and the cat group having a cat.
Who cannot join
- Not agreeing to participate in the research,
- Being under 18 years of age,
- Having known psychological disorders, having a visual, hearing, or speech disability, and having an animal allergy.
- Also excluded are having a surgical wound (suture, drainage, etc.), neutropenia or severe infection (by resistant bacteria), fever, diarrhea, respiratory symptoms or vomiting during the week before the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients' Post-Chemotherapy Symptoms and Happiness Levels: A Randomized Controlled Study
It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined.
Read the detailed description
Cancer is a disease that requires a long-term struggle with the psychosocial and economic burden it creates on the individual, family and society, bringing with it many health problems. Although chemotherapy treatment is the main treatment method for patients, it can cause some changes in the individual's appearance while treating cancer and many symptoms such as nausea, vomiting, diarrhea, alopecia, and constipation after treatment. At the same time, patients may feel tired, sleepy and depressed after treatment. However, cancer patients and their families experiencing some unknown diagnosis and treatment processes related to cancer also cause them to be unhappy as a result of experiencing some physical, social, emotional and spiritual problems during the treatment.
It is reported in the literature that pet therapy or animal-assisted treatments reduce disease-related symptoms and make patients happy. Pet therapy is an auxiliary non-pharmacological form of treatment that heals physiological and psychological diseases through interactions between animals and humans that meet certain criteria, and stimulates and activates the body mechanisms required for the development of the individual's health behaviors. In the literature, pet therapy studies with oncology patients are quite limited. Therefore, this study was conducted to examine the effects of live cat and robotic cat therapies on the symptoms and happiness levels experienced by oncology patients after chemotherapy.
- Conditions
- Therapy-Associated Cancer, Cancer Patient, Happiness, Symptoms
- Being tested
- Pet therapy
- Keywords
- pet therapy, cancer patient, happiness, symptoms
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pet therapyOther
The patients were allowed to spend time with an animal (cat/robotic cat) for 20 minutes twice a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Live Cat Group | Experimental | Before starting the study, the "Structured Patient Information Form," "Edmonton Symptom Diagnosis Scale," and "Oxford Happiness Scale Short Form" were applied to the patients. Then, the researcher gave the patients face-to-face, individual information about hand hygiene after contact with a live cat for approximately 15 minutes in the waiting room and offered them a "Live Cat Information Brochure." Patients were then asked to spend 20 minutes with a pet at home twice a week for 12 weeks. "Edmonton Symptom Diagnosis Scale" and "Oxford Happiness Scale Short Form" were applied to this group of patients three times: before, at the 6th week, and at the end of the 12th week of the study. Receives: Other: Pet therapy |
| Robotic Cat Group | Experimental | Before starting the study, the "Structured Patient Information Form," "Edmonton Symptom Diagnosis Scale," and "Oxford Happiness Scale Short Form" were applied to the patients. Then, the researcher gave the patients face-to-face information about the robotic cat "Silver" and its use for approximately 15 minutes in the waiting room and offered them a "Robotic Cat Information Brochure." In each pet therapy application, patients' hand hygiene and cleaning of the Robotic Cat was provided, the robot cat was given to the patients. Receives: Other: Pet therapy |
| Control Group | No intervention | Before starting the study, the "Structured Patient Information Form", "Edmonton Symptom Diagnosis Scale", and "Oxford Happiness Scale Short Form" were applied to the patients. Treatment was given to this group of patients only after informing them about the study, and the patients were followed for only three months. "Edmonton Symptom Diagnosis Scale" and "Oxford Happiness Scale Short FormS" were applied to the patients three times: before, at the 6th week, and the end of the 12th week of the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Symptom Diagnostic Scale
The scale includes "pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, the feeling of well-being, shortness of breath and other problems (changes in the skin and nails, sores in the mouth, numbness in the hands)." Sadırlı and Ünsar added other problems to the scale. Therefore, the current version with 11 items was used in this study. The severity of each symptom ranges from "no symptoms" to "very severe," with increasing numerical intensity between 0 and 10.
"Edmonton Symptom Diagnostic Scale" were administered to the patients three times in total before the study (pretest), at the sixth week/middle (intermediate measurement), and the end of the 12th week/end of the survey (posttest).
Measured: 12 Weeks
Oxford Happiness Scale Short Form
In the Turkish adaptation, the scale has seven items and a 5-point Likert type. The scores obtained from the items on the scale vary from "1 point: I Completely Disagree" to "5 points: I Completely Agree", with the lowest being seven and the highest being 35 points.
"Oxford Happiness Scale Short Form" were administered to the patients three times in total before the study (pretest), at the sixth week/middle (intermediate measurement), and the end of the 12th week/end of the survey (posttest).
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Jun 2023
- Primary completion15 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapy-Associated 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample number of the research was calculated in the G\*Power 3.1.9.6 program. While α=0.05 was the error amount, 0.628 was the effect size, and 0.90 (90%) was the targeted test power, it was calculated as 36 patients for three groups (living cat group, robotic cat group, control group). Since there was no previous study on the subject, a study examining happiness levels in a different sample group was used as a reference. Considering situations such as wanting to leave the study or death during the research, each group was increased by 25%, and a total of 45 patients, 15 patients for each group, were included in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Demirağ, Ph.D, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280612
- Sponsor's protocol ID
- RCS10042023
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I'll decide later
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Live Cat and Simulation Cat Therapies on Oncology Patients' Post-Chemotherapy Symptoms and Happiness Levels: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06280612
- Acronym / sponsor ID
- RCS10042023
- Conditions
- Therapy-Associated Cancer, Cancer Patient, Happiness, Symptoms
- Keywords
- pet therapy, cancer patient, happiness, symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 28 Feb 2024 (actual)
- 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.
It is known that animals are good for humans physiologically and psychologically. Therefore, in this study, the effects of live cat and robotic cat therapies on the symptoms and happiness levels of oncology patients after chemotherapy were examined.
Detailed description
Cancer is a disease that requires a long-term struggle with the psychosocial and economic burden it creates on the individual, family and society, bringing with it many health problems. Although chemotherapy treatment is the main treatment method for patients, it can cause some changes in the individual's appearance while treating cancer and many symptoms such as nausea, vomiting, diarrhea, alopecia, and constipation after treatment. At the same time, patients may feel tired, sleepy and depressed after treatment. However, cancer patients and their families experiencing some unknown diagnosis and treatment processes related to cancer also cause them to be unhappy as a result of experiencing some physical, social, emotional and spiritual problems during the treatment.
It is reported in the literature that pet therapy or animal-assisted treatments reduce disease-related symptoms and make patients happy. Pet therapy is an auxiliary non-pharmacological form of treatment that heals physiological and psychological diseases through interactions between animals and humans that meet certain criteria, and stimulates and activates the body mechanisms required for the development of the individual's health behaviors. In the literature, pet therapy studies with oncology patients are quite limited. Therefore, this study was conducted to examine the effects of live cat and robotic cat therapies on the symptoms and happiness levels experienced by oncology patients after chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The sample number of the research was calculated in the G*Power 3.1.9.6 program. While α=0.05 was the error amount, 0.628 was the effect size, and 0.90 (90%) was the targeted test power, it was calculated as 36 patients for three groups (living cat group, robotic cat group, control group). Since there was no previous study on the subject, a study examining happiness levels in a different sample group was used as a reference. Considering situations such as wanting to leave the study or death during the research, each group was increased by 25%, and a total of 45 patients, 15 patients for each group, were included in the study.
| Arm | Type | Receives |
|---|---|---|
| Live Cat Group | Experimental | Other: Pet therapyBefore starting the study, the "Structured Patient Information Form," "Edmonton Symptom Diagnosis Scale," and "Oxford Happiness Scale Short Form" were applied to the patients. Then, the researcher gave the patients face-to-face, individual information about hand hygiene after contact with a live cat for approximately 15 minutes in the waiting room and offered them a "Live Cat Information Brochure." Patients were then asked to spend 20 minutes with a pet at home twice a week for 12 weeks. "Edmonton Symptom Diagnosis Scale" and "Oxford Happiness Scale Short Form" were applied to this group of patients three times: before, at the 6th week, and at the end of the 12th week of the study. |
| Robotic Cat Group | Experimental | Other: Pet therapyBefore starting the study, the "Structured Patient Information Form," "Edmonton Symptom Diagnosis Scale," and "Oxford Happiness Scale Short Form" were applied to the patients. Then, the researcher gave the patients face-to-face information about the robotic cat "Silver" and its use for approximately 15 minutes in the waiting room and offered them a "Robotic Cat Information Brochure." In each pet therapy application, patients' hand hygiene and cleaning of the Robotic Cat was provided, the robot cat was given to the patients. |
| Control Group | No intervention | –Before starting the study, the "Structured Patient Information Form", "Edmonton Symptom Diagnosis Scale", and "Oxford Happiness Scale Short Form" were applied to the patients. Treatment was given to this group of patients only after informing them about the study, and the patients were followed for only three months. "Edmonton Symptom Diagnosis Scale" and "Oxford Happiness Scale Short FormS" were applied to the patients three times: before, at the 6th week, and the end of the 12th week of the research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Criteria for admission to the study are 18≤ of age,
- Agreeing to participate in the research,
- Being conscious of receiving outpatient chemotherapy treatment for 3≤ months, and being able to communicate.
- The criteria included no impairment in mental and cognitive functions of patients/relatives in the live group,
- Patients in the live cat group not having any animal allergies, and the cat group having a cat.
Key exclusion criteria (4 listed)
- Not agreeing to participate in the research,
- Being under 18 years of age,
- Having known psychological disorders, having a visual, hearing, or speech disability, and having an animal allergy.
- Also excluded are having a surgical wound (suture, drainage, etc.), neutropenia or severe infection (by resistant bacteria), fever, diarrhea, respiratory symptoms or vomiting during the week before the start of the study.
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 |
|---|---|---|
| Pet therapyThe patients were allowed to spend time with an animal (cat/robotic cat) for 20 minutes twice a week for 12 weeks. | Other | Live Cat Group, Robotic Cat Group |
Primary outcome
Edmonton Symptom Diagnostic Scale
Time frame: 12 Weeks
The scale includes "pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, the feeling of well-being, shortness of breath and other problems (changes in the skin and nails, sores in the mouth, numbness in the hands)." Sadırlı and Ünsar added other problems to the scale. Therefore, the current version with 11 items was used in this study. The severity of each symptom ranges from "no symptoms" to "very severe," with increasing numerical intensity between 0 and 10. "Edmonton Symptom Diagnostic Scale" were administered to the patients three times in total before the study (pretest), at the sixth week/middle (intermediate measurement), and the end of the 12th week/end of the survey (posttest).
Oxford Happiness Scale Short Form
Time frame: 12 Weeks
In the Turkish adaptation, the scale has seven items and a 5-point Likert type. The scores obtained from the items on the scale vary from "1 point: I Completely Disagree" to "5 points: I Completely Agree", with the lowest being seven and the highest being 35 points. "Oxford Happiness Scale Short Form" were administered to the patients three times in total before the study (pretest), at the sixth week/middle (intermediate measurement), and the end of the 12th week/end of the survey (posttest).
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 1 Mar 2024.
- Individual participant dataSharing planned: No. I'll decide later
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pet therapy in people with Therapy-Associated Cancer and Cancer Patient, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 5 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 1 Mar 2024. 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 Turkey (Türkiye). 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.
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?
Edmonton Symptom Diagnostic Scale (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2024.