Self CareNCT05683652
The Effect of Education and Telephone Follow-up Given to Cancer Patients Receiving Immunotherapy on Symptom Management and Self-care Power
A study testing TRAINING BOOKLET in people with Self Care and Symptom Management, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study, it was aimed to evaluate the effects of education and telephone follow-up given to cancer patients receiving immunotherapy on symptom management and self-care power. It is expected that the education given to the patients who will receive immunotherapy for the first time and the monitoring by phone… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Care, Symptom Management, Immunotherapy
- What is being tested?
- TRAINING BOOKLET
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2021to Apr 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to read and write in Turkish,
- Absence of any psychiatric disorder that will reduce the ability to comprehend and understand,
- Not having any physical discomfort in the area of hearing or speaking that would prevent telephone conversations,
- Will receive immunotherapy for the first time and only,
- Willingness to participate in the research,
- Willingness to participate in the research,
- Patients who agreed to participate in the study verbally and in writing were included in the study.
Who cannot join
- Not being voluntarily or willing to participate in the research,
- Will receive radiotherapy or chemotherapy together with immunotherapy,
- Not knowing that he will receive immunotherapy,
- Patients who did not accept to participate in the study were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Medipol University
Ankara
Lecturer, 5077476389
About this study
This study, it was aimed to evaluate the effects of education and telephone follow-up given to cancer patients receiving immunotherapy on symptom management and self-care power. It is expected that the education given to the patients who will receive immunotherapy for the first time and the monitoring by phone, prevention of immunotherapy-related side effects, early recognition, and follow-up will reduce unnecessary hospital admissions and increase the self-care power of the patient.
Read the detailed description
The research consists of two parts. For the qualitative part of the research; A semi-structured interview form was created. In this form, face-to-face interviews were conducted with the patients receiving immunotherapy about the symptoms they experienced, how they coped, and the subjects they wanted to learn.
Quantitative part for sample selection; G Power 3.1 statistical program was used to calculate the sample size of the study. After calculating the effect size as 0.73 by using the standard deviation and group averages of the Self-Care Scale of the study closest to the research, the sample calculation was made (Çetin,2020). According to this; The sample size was calculated with a total of 56 patients, 28 people in both groups, with a power of 85% in the 95% confidence interval. However, due to the possible losses in the number of patients, 33 people were planned for both groups, with a total of 66 patients (Çetin A.A.2020).
A randomization list created with a computer-based random number sequence was used to ensure the random distribution of the patients scheduled for immunotherapy to the groups (www.random.org). The patients were numbered according to the order of arrival, and the patients were assigned to the groups (intervention group with training and followed up by phone, and control group with routine follow-up) according to the numbers in the randomization list. Due to the nature of the study, the principal investigator and patients could not be blinded during grouping. However, single-blind randomization was achieved by blinding the evaluator groups.
- Conditions
- Self Care, Symptom Management, Immunotherapy, Cancer Patient
- Being tested
- TRAINING BOOKLET
- Keywords
- Immunotherapy, Symptom Management, Self care power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAINING BOOKLETDevice
Also called Telephone follow up
Cancer patients in the intervention group, who will receive immunotherapy for the first time, will be given face-to-face training with the prepared training booklet and followed up by phone. Patients who received immunotherapy after the 1st, 2nd and 3rd cycles, respectively, will be called by phone. The researcher's phone number will be given to the intervention group patients and they will be told that they can call 24/7 if they experience any symptoms. The telephone interview form created by the researcher will be used during the monitoring by telephone.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightingale Symptom Rating Scale
Nightingale Symptom Assessment Scale (N-SDS) is a quality of life scale developed by Gülbeyaz Can and Adnan Aydıner in 2009 for cancer patients. Consisting of 38 items in total, the scale (N-CSS) has three sub-dimensions: Physical Well-Being (Physician) (items 1-4, 6-15, 23-27 and 37), Social Well-Being (SoIH) (5 and Articles 16-22) and Psychological Well-Being (PSYH) (Articles 28-36 and 38). When each item in the scale is used alone, it can be reflected how the cancer patients who are planned to receive or receiving chemotherapy are affected by the disease/treatment-related problems. In this Likert-type scale, the answer given by the patient to the evaluated item is scored as "0", if it is very little, "1", if it is a little, "2", if it is quite a lot, "3", and if it is too much, it is scored as "4". A high score indicates that the level of being affected by the disease/treatment-related problems is high.
Measured: In patients receiving immunotherapy, the first measurements will be made at the end of the 1st cycle (the cycle is 28 days)
Demographic and Medical Characteristics - Patient Information Form
It consists of a total of 8 questions created by the researcher after the literature review. 6 questions include medical characteristics, 2 questions include demographic characteristics.
Measured: It will meet within 3 months with patients who agree to participate in the study.
Telephone Interview Form
atients who were given pre-immunotherapy training will be called after each cure and interviewed for symptom management. A telephone interview form was created by the researcher to record the interviews.
Measured: Patients in the experimental group receiving immunotherapy will be followed up by phone for 3 months.
Phone Call Evaluation Form
A phone call evaluation form prepared by the researcher will be used to evaluate the phone calls made after each cure. It will be applied to the intervention group as a post-test.
Measured: It will be applied to the patients in the experimental group as a result of 3-month follow-up.
Self Care Power Scale
The scale used to measure an individual's self-care ability or self-care power was developed by Kearney and Fleicher (1979) in English with 43 items, and is a 35-item shortened Turkish form. The scale focused on individuals' self-assessment of their involvement in self-care actions. Each statement is scored from 0 to 4. Individuals' orientation towards self-care is determined by participants' responses on a 5-point Likert-type scale. Among the answer options, "Doesn't describe me at all" is given 0 points, the others are given 1 point for "Doesn't describe me very well", 2 points for "I have no idea", 3 points for "Describes me a little", and 4 points for "Describes me a lot".In the Turkishized scale, 8 items (3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and the scoring is reversed. The maximum score is 140. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual. There is no limit/cut off value.
Measured: The first measurements of the patients receiving immunotherapy will be done at the end of the 1st cycle (each cycle is 28 days)
Secondary outcomes (2)
Nightingale Symptom Rating Scale
Nightingale Symptom Assessment Scale (N-SDS) is a quality of life scale developed by Gülbeyaz Can and Adnan Aydıner in 2009 for cancer patients. Consisting of 38 items in total, the scale (N-CSS) has three sub-dimensions: Physical Well-Being (Physician) (items 1-4, 6-15, 23-27 and 37), Social Well-Being (SoIH) (5 and Articles 16-22) and Psychological Well-Being (PSYH) (Articles 28-36 and 38). When each item in the scale is used alone, it can be reflected how the cancer patients who are planned to receive or receiving chemotherapy are affected by the disease/treatment-related problems. In this Likert-type scale, the answer given by the patient to the evaluated item is scored as "0", if it is very little, "1", if it is a little, "2", if it is quite a lot, "3", and if it is too much, it is scored as "4". A high score indicates that the level of being affected by the disease/treatment-related problems is high.
Measured: In patients receiving immunotherapy, the second measurements will be made at the end of the third cycle (the cycle is 28 days)
Self Care Power Scale
The scale used to measure an individual's self-care ability or self-care power was developed by Kearney and Fleicher (1979) in English with 43 items, and is a 35-item shortened Turkish form. The scale focused on individuals' self-assessment of their involvement in self-care actions. Each statement is scored from 0 to 4. Individuals' orientation towards self-care is determined by participants' responses on a 5-point Likert-type scale. Among the answer options, "Doesn't describe me at all" is given 0 points, the others are given 1 point for "Doesn't describe me very well", 2 points for "I have no idea", 3 points for "Describes me a little", and 4 points for "Describes me a lot".In the Turkishized scale, 8 items (3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and the scoring is reversed. The maximum score is 140. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual. There is no limit/cut off value.
Measured: n patients receiving immunotherapy, the second measurements will be made at the end of the third cycle (the cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start30 Jun 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self CareStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze ALINCAK, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683652
- Sponsor's protocol ID
- E-84892257-300-100327
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Telephone Follow-up Given to Cancer Patients Receiving Immunotherapy on Symptom Management and Self-care Power
- ClinicalTrials.gov ID
- NCT05683652
- Acronym / sponsor ID
- E-84892257-300-100327
- Conditions
- Self Care, Symptom Management, Immunotherapy, Cancer Patient
- Keywords
- Immunotherapy, Symptom Management, Self care power
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 13 Jan 2023 (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.
This study, it was aimed to evaluate the effects of education and telephone follow-up given to cancer patients receiving immunotherapy on symptom management and self-care power. It is expected that the education given to the patients who will receive immunotherapy for the first time and the monitoring by phone, prevention of immunotherapy-related side effects, early recognition, and follow-up will reduce unnecessary hospital admissions and increase the self-care power of the patient.
Detailed description
The research consists of two parts. For the qualitative part of the research; A semi-structured interview form was created. In this form, face-to-face interviews were conducted with the patients receiving immunotherapy about the symptoms they experienced, how they coped, and the subjects they wanted to learn.
Quantitative part for sample selection; G Power 3.1 statistical program was used to calculate the sample size of the study. After calculating the effect size as 0.73 by using the standard deviation and group averages of the Self-Care Scale of the study closest to the research, the sample calculation was made (Çetin,2020). According to this; The sample size was calculated with a total of 56 patients, 28 people in both groups, with a power of 85% in the 95% confidence interval. However, due to the possible losses in the number of patients, 33 people were planned for both groups, with a total of 66 patients (Çetin A.A.2020).
A randomization list created with a computer-based random number sequence was used to ensure the random distribution of the patients scheduled for immunotherapy to the groups (www.random.org). The patients were numbered according to the order of arrival, and the patients were assigned to the groups (intervention group with training and followed up by phone, and control group with routine follow-up) according to the numbers in the randomization list. Due to the nature of the study, the principal investigator and patients could not be blinded during grouping. However, single-blind randomization was achieved by blinding the evaluator groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to read and write in Turkish,
- Absence of any psychiatric disorder that will reduce the ability to comprehend and understand,
- Not having any physical discomfort in the area of hearing or speaking that would prevent telephone conversations,
- Will receive immunotherapy for the first time and only,
- Willingness to participate in the research,
Key exclusion criteria (4 listed)
- Not being voluntarily or willing to participate in the research,
- Will receive radiotherapy or chemotherapy together with immunotherapy,
- Not knowing that he will receive immunotherapy,
- Patients who did not accept to participate in the study were not included in 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 |
|---|---|---|
| TRAINING BOOKLETAlso: Telephone follow upCancer patients in the intervention group, who will receive immunotherapy for the first time, will be given face-to-face training with the prepared training booklet and followed up by phone. Patients who received immunotherapy after the 1st, 2nd and 3rd cycles, respectively, will be called by phone. The researcher's phone number will be given to the intervention group patients and they will be told that they can call 24/7 if they experience any symptoms. The telephone interview form created by the researcher will be used during the monitoring by telephone. | Device | – |
Primary outcome
Nightingale Symptom Rating Scale
Time frame: In patients receiving immunotherapy, the first measurements will be made at the end of the 1st cycle (the cycle is 28 days)
Nightingale Symptom Assessment Scale (N-SDS) is a quality of life scale developed by Gülbeyaz Can and Adnan Aydıner in 2009 for cancer patients. Consisting of 38 items in total, the scale (N-CSS) has three sub-dimensions: Physical Well-Being (Physician) (items 1-4, 6-15, 23-27 and 37), Social Well-Being (SoIH) (5 and Articles 16-22) and Psychological Well-Being (PSYH) (Articles 28-36 and 38). When each item in the scale is used alone, it can be reflected how the cancer patients who are planned to receive or receiving chemotherapy are affected by the disease/treatment-related problems. In this Likert-type scale, the answer given by the patient to the evaluated item is scored as "0", if it is very little, "1", if it is a little, "2", if it is quite a lot, "3", and if it is too much, it is scored as "4". A high score indicates that the level of being affected by the disease/treatment-related problems is high.
Demographic and Medical Characteristics - Patient Information Form
Time frame: It will meet within 3 months with patients who agree to participate in the study.
It consists of a total of 8 questions created by the researcher after the literature review. 6 questions include medical characteristics, 2 questions include demographic characteristics.
Telephone Interview Form
Time frame: Patients in the experimental group receiving immunotherapy will be followed up by phone for 3 months.
atients who were given pre-immunotherapy training will be called after each cure and interviewed for symptom management. A telephone interview form was created by the researcher to record the interviews.
Phone Call Evaluation Form
Time frame: It will be applied to the patients in the experimental group as a result of 3-month follow-up.
A phone call evaluation form prepared by the researcher will be used to evaluate the phone calls made after each cure. It will be applied to the intervention group as a post-test.
Self Care Power Scale
Time frame: The first measurements of the patients receiving immunotherapy will be done at the end of the 1st cycle (each cycle is 28 days)
The scale used to measure an individual's self-care ability or self-care power was developed by Kearney and Fleicher (1979) in English with 43 items, and is a 35-item shortened Turkish form. The scale focused on individuals' self-assessment of their involvement in self-care actions. Each statement is scored from 0 to 4. Individuals' orientation towards self-care is determined by participants' responses on a 5-point Likert-type scale. Among the answer options, "Doesn't describe me at all" is given 0 points, the others are given 1 point for "Doesn't describe me very well", 2 points for "I have no idea", 3 points for "Describes me a little", and 4 points for "Describes me a lot".In the Turkishized scale, 8 items (3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and the scoring is reversed. The maximum score is 140. The high score obtained from the scale indicates the high level of self-care or self-care ability and power of the individual. There is no limit/cut off value.
2 secondary outcomes
Nightingale Symptom Rating Scale
Time frame: In patients receiving immunotherapy, the second measurements will be made at the end of the third cycle (the cycle is 28 days)
Self Care Power Scale
Time frame: n patients receiving immunotherapy, the second measurements will be made at the end of the third cycle (the cycle is 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAINING BOOKLET in people with Self Care and Symptom Management, run by Ankara Medipol 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 7 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: status not confirmed, as of the sponsor's last update on 13 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nightingale Symptom Rating Scale (time frame: In patients receiving immunotherapy, the first measurements will be made at the end of the 1st cycle (the cycle is 28 days)). 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 13 Jan 2023.