Tumor Chemotherapy PatientsNCT05643937
Construction and Application of Precise Health Education Model for Patients With PICC Tube
A study testing Routine health education and Routine health education + precise health education in people with Tumor Chemotherapy Patients, run by Junyan Zhao at 1 site in China.
Trial summary
1. In this study, the risk factors leading to catheter-related complications in the daily life behavior habits of patients with PICC catheter were identified, refined and initially established, and the Delphi method (expert consultation method) was used to further identify the existing and potential risk factors… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor Chemotherapy Patients
- What is being tested?
- Routine health education and Routine health education + precise health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2022to 30 Jan 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cancer patients undergoing chemotherapy in our hospital with ≥6 cycles of chemotherapy;
- Patients with PICC implanted for the first time and maintained at our hospital;
- Aged 18-60 years;
- The material and performance of PICC catheter are silicone three-way valve catheter;
- Catheter placement under the guidance of portable color Doppler ultrasound diagnostic instrument;
- Clear consciousness, good language communication skills and normal comprehension ability;
- Informed consent and voluntary participation in the study.
Who cannot join
- Persons with self-care ability defects;
- Puncture times more than 1 time.
Trial locations and contacts
1 site in 1 country.
About this study
- In this study, the risk factors leading to catheter-related complications in the daily life behavior habits of patients with PICC catheter were identified, refined and initially established, and the Delphi method (expert consultation method) was used to further identify the existing and potential risk factors leading to PICC catheter-related complications in the daily life behavior habits of patients. To develop individualized and precise health education programs for risk factors, in order to build an accurate health education model centered on improving patients' daily life and behavior habits.
- To conduct clinical empirical study to evaluate the feasibility and effectiveness of precise health education program for PICC patients with catheter, and to observe the impact of this health education model on the knowledge, attitude and practice level of daily management, self-management efficacy and the incidence of related complications after catheter insertion in PICC patients, so as to provide a reference for health education of PICC patients.
- Conditions
- Tumor Chemotherapy Patients
- Being tested
- Routine health education, Routine health education + precise health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine health educationBehavioural
The control group received routine health education after catheterization, including introducing the purpose, method, advantages and complications of PICC insertion to patients before catheterization and signing informed consent. During catheterization, PICC assistant explained relevant matters needing attention and cooperative actions to the patient. After catheterization, patients were instructed to carry out grip training and limb activities.
Routine health education + precise health educationBehavioural
On the basis of routine health education in the control group, the experimental group screened the high-risk behaviors of patients through the questionnaire of daily life behavior habits, and formulated the precise and concrete health education program for their high-risk behaviors
| Study group | Role | What they receive |
|---|---|---|
| The control group | Active comparator | The control group received routine health education after catheterization, including introducing the purpose, method, advantages and complications of PICC insertion to patients before catheterization and signing informed consent. During catheterization, PICC assistant explained relevant matters needing attention and cooperative actions to the patient. After catheterization, patients were instructed to carry out grip training and limb activities. Receives: Behavioral: Routine health education |
| Experimental group | Experimental | On the basis of routine health education in the control group, the experimental group screened the high-risk behaviors of patients through the questionnaire of daily life behavior habits, and formulated the precise and concrete health education program for their high-risk behaviors Receives: Behavioral: Routine health education + precise health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications associated with PICC catheter
It is determined by PICC specialist nurse/sonographer during each patient maintenance
Measured: Six cycles of chemotherapy,Each chemotherapy cycle lasted 28 days
Secondary outcomes (3)
Knowledge, attitude and practice score of daily management of patients with PICC tube
Through the results of PICC daily management knowledge, attitude and practice questionnaire, the scores of daily management knowledge, attitude and practice before and after intervention were analyzed and compared between the two groups
Measured: Patients before catheterization and after 6 cycles of chemotherapy
Scores of self-management efficacy of patients with PICC tube
Through the results of self-management efficacy questionnaire of patients with PICC tube, the scores of self-management efficacy before and after intervention were analyzed and compared between the two groups.
Measured: A total of 6 chemotherapy cycles were observed before catheterization and after each chemotherapy cycle (28 days)
Satisfaction of health education of patients with PICC tube
Through the results of the health education satisfaction questionnaire of patients with PICC tube, the satisfaction of the two groups of patients with health education after intervention was analyzed and compared.
Measured: A total of 6 chemotherapy cycles were observed before catheterization and after each chemotherapy cycle (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start28 Jul 2022
- Primary completion28 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Chemotherapy PatientsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Junyan Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junyan Zhao, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643937
- Sponsor's protocol ID
- YXLL-KY-2022(067)
- Status last verified
- Feb 2023
- First submitted
- 24 Aug 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of Precise Health Education Model for Patients With PICC Tube
- ClinicalTrials.gov ID
- NCT05643937
- Acronym / sponsor ID
- YXLL-KY-2022(067)
- Conditions
- Tumor Chemotherapy Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Junyan ZhaoUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 9 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.
- In this study, the risk factors leading to catheter-related complications in the daily life behavior habits of patients with PICC catheter were identified, refined and initially established, and the Delphi method (expert consultation method) was used to further identify the existing and potential risk factors leading to PICC catheter-related complications in the daily life behavior habits of patients. To develop individualized and precise health education programs for risk factors, in order to build an accurate health education model centered on improving patients' daily life and behavior habits.
- To conduct clinical empirical study to evaluate the feasibility and effectiveness of precise health education program for PICC patients with catheter, and to observe the impact of this health education model on the knowledge, attitude and practice level of daily management, self-management efficacy and the incidence of related complications after catheter insertion in PICC patients, so as to provide a reference for health education of PICC patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | Active comparator | Behavioral: Routine health educationThe control group received routine health education after catheterization, including introducing the purpose, method, advantages and complications of PICC insertion to patients before catheterization and signing informed consent. During catheterization, PICC assistant explained relevant matters needing attention and cooperative actions to the patient. After catheterization, patients were instructed to carry out grip training and limb activities. |
| Experimental group | Experimental | Behavioral: Routine health education + precise health educationOn the basis of routine health education in the control group, the experimental group screened the high-risk behaviors of patients through the questionnaire of daily life behavior habits, and formulated the precise and concrete health education program for their high-risk behaviors |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Cancer patients undergoing chemotherapy in our hospital with ≥6 cycles of chemotherapy;
- Patients with PICC implanted for the first time and maintained at our hospital;
- Aged 18-60 years;
- The material and performance of PICC catheter are silicone three-way valve catheter;
- Catheter placement under the guidance of portable color Doppler ultrasound diagnostic instrument;
Key exclusion criteria (2 listed)
- Persons with self-care ability defects;
- Puncture times more than 1 time.
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 |
|---|---|---|
| Routine health educationThe control group received routine health education after catheterization, including introducing the purpose, method, advantages and complications of PICC insertion to patients before catheterization and signing informed consent. During catheterization, PICC assistant explained relevant matters needing attention and cooperative actions to the patient. After catheterization, patients were instructed to carry out grip training and limb activities. | Behavioural | The control group |
| Routine health education + precise health educationOn the basis of routine health education in the control group, the experimental group screened the high-risk behaviors of patients through the questionnaire of daily life behavior habits, and formulated the precise and concrete health education program for their high-risk behaviors | Behavioural | Experimental group |
Primary outcome
Incidence of complications associated with PICC catheter
Time frame: Six cycles of chemotherapy,Each chemotherapy cycle lasted 28 days
It is determined by PICC specialist nurse/sonographer during each patient maintenance
3 secondary outcomes
Knowledge, attitude and practice score of daily management of patients with PICC tube
Time frame: Patients before catheterization and after 6 cycles of chemotherapy
Scores of self-management efficacy of patients with PICC tube
Time frame: A total of 6 chemotherapy cycles were observed before catheterization and after each chemotherapy cycle (28 days)
Satisfaction of health education of patients with PICC tube
Time frame: A total of 6 chemotherapy cycles were observed before catheterization and after each chemotherapy cycle (28 days)
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 3 Feb 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.
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 Routine health education and Routine health education + precise health education in people with Tumor Chemotherapy Patients, run by Junyan Zhao at 1 site in China.
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 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 3 Feb 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 China. 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?
Incidence of complications associated with PICC catheter (time frame: Six cycles of chemotherapy,Each chemotherapy cycle lasted 28 days). 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 3 Feb 2023.