CancerNCT05652764
Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients
A study testing Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients in people with Cancer and Nurse's Role, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to determine the effects of nursing interventions based on Orem Self-Care Deficiency Theory on symptom management, care needs and quality of life in cancer patients who underwent immunotherapy. Method: The research was planned as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Nurse's Role, Treatment Side Effects
- What is being tested?
- Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Coming to Antalya Training and Research Hospital Medical Oncology unit for treatment,
- First time taking one of the immune checkpoint inhibitors (Ipilimumab CTLA-4, Pembrolizumab PD-1, Nivolumab PD-1, Atezolizumab PDL-1),
- Speaking and understanding Turkish,
- Being literate,
- 18 Years and older
- With solid tumor,
Show all 9Show fewer
- No communication barrier
- Being able to communicate by phone
- Individuals who agree to participate in the research.
Who cannot join
- Patients receiving other cancer treatments in combination with immunotherapy,
- Patients with Eastern Cooperative Oncology Group Performance Scale 4.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Orem's Self-Care Deficit Theory Based Nursing Interventions on Symptom Management, Care Needs and The Quality of Life of Immunotherapy Treated Cancer Patients
Objective: The aim of this study was to determine the effects of nursing interventions based on Orem Self-Care Deficiency Theory on symptom management, care needs and quality of life in cancer patients who underwent immunotherapy.
Method: The research was planned as a randomized controlled trial. The research is planned to be carried out in the Medical Oncology unit of the Health Sciences University Antalya Training and Research Hospital. It is planned to be done with 58 patients, 29 experimental and 29 control groups. Based on Orem Self-Care Deficit Theory; face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned. Patient Description Form, Supportive Care Needs Scale-Short Form, Memorial Symptom Assessment Scale, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scale and Self-Care Strength Scale will be used to collect data.
- Conditions
- Cancer, Nurse's Role, Treatment Side Effects, Quality of Life
- Being tested
- Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients
- Keywords
- Cancer Immunotherapy, Treatment Side Effects, Symptom Management, Self-Care Deficiency, Care Needs, Oncology Nursing
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer PatientsOther
In this study, face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Immuno-SelfCare | Experimental | Not described Receives: Other: Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Symptom on the Memorial Symptom Assessment Scale at week 12
Memorial Symptom Assessment Scale (MSAS): The Memorial Symptom Assessment Scale is a multidimensional self-report questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.The total score is the average of the responses to the distress scale items and and ranges from 0 to 4 with higher values indicating greater distress experienced from symptoms.
Measured: Baseline and 12th week
Change from Baseline in Supportive Care Needs on the Supportive Care Needs Scale-Short Form at week 12
Supportive Care Needs Scale-Short Form: The 31-item instrument measures supportive care needs in five domains: health system and information, psychological needs, physical and daily living, patient care and support, and sexual-related. Responses are given on a scale from 1 to 5 where 1 = no help is needed and 5 = high need for help. Total scores range from 31 to 155 and higher scores indicate greater need for help.
Measured: Baseline and 12th week
Change from Baseline in Self-Care Strength on the Self-Care Strength Scale at week 12
Self-Care Strength Scale: A maximum score of 140 is taken from the scale. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual.
Measured: Baseline and 12th week
Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) at week 12
EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire): This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.
Measured: Baseline and 12th week
Change from Baseline in Adverse Events on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for 12 weeks
NCI-Common Terminology Criteria for Adverse Events Version 5.0: These algorithms provide support for prescribing the necessary treatment for grade 1 and grade 2 adverse events and for creating special care plans for grade 3 and 4 adverse events.
Measured: Baseline,for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Jan 2023
- Primary completion30 Aug 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial consisting of two groups: experimental and control.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mevlüde Ergen, Akdeniz University
- Investigators
- Fatma Arikan, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652764
- Sponsor's protocol ID
- KAEK- 685
- Status last verified
- Jun 2024
- First submitted
- 3 Dec 2022
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orem's Self-Care Deficit Theory Based Nursing Interventions on Symptom Management, Care Needs and The Quality of Life of Immunotherapy Treated Cancer Patients
- ClinicalTrials.gov ID
- NCT05652764
- Acronym / sponsor ID
- KAEK- 685
- Conditions
- Cancer, Nurse's Role, Treatment Side Effects, Quality of Life
- Keywords
- Cancer Immunotherapy, Treatment Side Effects, Symptom Management, Self-Care Deficiency, Care Needs, Oncology Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 15 Dec 2022 (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.
Objective: The aim of this study was to determine the effects of nursing interventions based on Orem Self-Care Deficiency Theory on symptom management, care needs and quality of life in cancer patients who underwent immunotherapy.
Method: The research was planned as a randomized controlled trial. The research is planned to be carried out in the Medical Oncology unit of the Health Sciences University Antalya Training and Research Hospital. It is planned to be done with 58 patients, 29 experimental and 29 control groups. Based on Orem Self-Care Deficit Theory; face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned. Patient Description Form, Supportive Care Needs Scale-Short Form, Memorial Symptom Assessment Scale, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Scale and Self-Care Strength Scale will be used to collect data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial consisting of two groups: experimental and control.
| Arm | Type | Receives |
|---|---|---|
| Immuno-SelfCare | Experimental | Other: Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Coming to Antalya Training and Research Hospital Medical Oncology unit for treatment,
- First time taking one of the immune checkpoint inhibitors (Ipilimumab CTLA-4, Pembrolizumab PD-1, Nivolumab PD-1, Atezolizumab PDL-1),
- Speaking and understanding Turkish,
- Being literate,
- 18 Years and older
Key exclusion criteria (2 listed)
- Patients receiving other cancer treatments in combination with immunotherapy,
- Patients with Eastern Cooperative Oncology Group Performance Scale 4.
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 |
|---|---|---|
| Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer PatientsIn this study, face-to-face patient education, giving patient education booklet, preparation of symptom management card, face-to-face and telephone counseling initiatives were planned to the experimental group. | Other | Immuno-SelfCare |
Primary outcome
Change from Baseline in Symptom on the Memorial Symptom Assessment Scale at week 12
Time frame: Baseline and 12th week
Memorial Symptom Assessment Scale (MSAS): The Memorial Symptom Assessment Scale is a multidimensional self-report questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.The total score is the average of the responses to the distress scale items and and ranges from 0 to 4 with higher values indicating greater distress experienced from symptoms.
Change from Baseline in Supportive Care Needs on the Supportive Care Needs Scale-Short Form at week 12
Time frame: Baseline and 12th week
Supportive Care Needs Scale-Short Form: The 31-item instrument measures supportive care needs in five domains: health system and information, psychological needs, physical and daily living, patient care and support, and sexual-related. Responses are given on a scale from 1 to 5 where 1 = no help is needed and 5 = high need for help. Total scores range from 31 to 155 and higher scores indicate greater need for help.
Change from Baseline in Self-Care Strength on the Self-Care Strength Scale at week 12
Time frame: Baseline and 12th week
Self-Care Strength Scale: A maximum score of 140 is taken from the scale. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual.
Change from Baseline in Quality of Life Level on the EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) at week 12
Time frame: Baseline and 12th week
EORTC QLQ-C30 Quality of Life Scale(European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire): This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.
Change from Baseline in Adverse Events on the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 for 12 weeks
Time frame: Baseline,for 12 weeks
NCI-Common Terminology Criteria for Adverse Events Version 5.0: These algorithms provide support for prescribing the necessary treatment for grade 1 and grade 2 adverse events and for creating special care plans for grade 3 and 4 adverse events.
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 10 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Fatma Arikan study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orem's Self-Care Deficit Theory Based Nursing Interventions for Immunotherapy Treated Cancer Patients in people with Cancer and Nurse's Role, run by Akdeniz 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 9 inclusion and 2 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 10 Jun 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?
Change from Baseline in Symptom on the Memorial Symptom Assessment Scale at week 12 (time frame: Baseline and 12th week). The study lists 5 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 10 Jun 2024; AzTrials last refreshed its copy on 28 Oct 2026.