EducationNCT05750199
The Effectiveness of "Multi-Immunotherapy Special Training Courses Through Digital Media and Workshop" Intervention for Oncology Nurses: Exploration of Educational Needs, Curriculum Planning, Implementation and Evaluation
A study testing Immunotherapy Special Training Course (ISTC) and Advanced Oncology Nurse Training Course (AONTC) in people with Education and Oncology, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study is a 2-year qualitative and quantitative mixed method research project and consists of two phases.The study will provide useful clinical data to help us better understand educational needs of immunotherapy for oncology nurses. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Immunotherapy Special Training Course (ISTC) and Advanced Oncology Nurse Training Course (AONTC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Apr 2021to 19 Oct 2022
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 20 years old (inclusive).
- Nurses or case managers who have completed the training of oncology nursing courses in their hospitals.
- Caring experiences of cancer patients who undergoing immunotherapy.
- The working experience of the oncology unit is at least 1 years.
Who cannot join
- 1. Those who are unwilling or unable to participate in the full four-month course training.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a 2-year qualitative and quantitative mixed method research project and consists of two phases.The study will provide useful clinical data to help us better understand educational needs of immunotherapy for oncology nurses. This ISTC model will lead to further validation of an oncology care training course model designed to better prepare and support cancer patients and their families to existing and new anti-cancer therapies.
Read the detailed description
Background: More and more cancer patients are receiving immunotherapy. However, patients and their families are overwhelmingly not fully aware of the side effects of immunotherapy or the related management involved while simultaneously experiencing both financial and spiritual burden. Thus, educating the needs of immunotherapy and the development and planning of immunotherapy-related training courses for oncology nurses are necessary.
Purpose: (1) To explore the educational needs for immunotherapy in oncology nurses. (2) To develop and evaluate the effectiveness of "Multi-Immunotherapy Special Training Courses through Digital Media and Workshop" intervention" (short for Immunotherapy Special Training Course (ISTC)" on immunotherapy related care indicators and the feasibility of the ISTC.
Method: This study is a 2-year qualitative and quantitative mixed method research project and consists of two phases: (1) The qualitative method will be conducted using phenomenological methods and snowball sampling. In-depth interviews and observations by one researcher will be adopted in this study. The sample size is determined as the number of samples collected until saturated data analysis is achieved. (2) The quantitative method will be conducted as a quasi-experimental research with a two group pretest-posttest. For the experimental group, snowball sampling will be used to recruit participants who are recommended by a cooperative teaching hospital in the North, Central, South and East Districts of Taiwan to participate in the ISTC training. The duration is to last 16 weeks and includes 8 hours of digital media training and 2 days of workshop training. For the control group, convenient sampling will be used to recruit participants attending the "Advanced Oncology Nurse Training Course (AONTC) (during 4 weeks, 8 days)." which will be held by the Taiwan Oncology Nursing Society. Each group will be followed for 3 to 4 months and their outcomes will be assessed at 3 time points: baseline (pre-training course), and 8, 12 weeks after the training course, T0-T2, respectively. Outcomes will be evaluated based on immunotherapy knowledge, self-efficacy of caring responsible for patients undergoing immunotherapy, critical thinking ability, and ability of communication. Additionally, in the experimental group, outcomes will also be evaluated by mini-clinical evaluation exercise, mini-CEX at T2 and learning passport at 16 weeks after training course (T3). Estimated subject number would be 60 for each group. Results would be analyzed mainly by GEE. After obtaining approval from the institutional review board of a medical center in northern Taiwan and getting the required consent, this study will commence.
Predicted results: The study will provide useful clinical data to help us better understand educational needs of immunotherapy for oncology nurses. This ISTC model will lead to further validation of an oncology care training course model designed to better prepare and support cancer patients and their families to existing and new anti-cancer therapies.
- Being tested
- Immunotherapy Special Training Course (ISTC), Advanced Oncology Nurse Training Course (AONTC)
- Keywords
- cancer, immunotherapy, oncology nurse, education need, training course
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy Special Training Course (ISTC)Other
16 weeks and includes 8 hours of digital media training and 2 days of workshop training.
Advanced Oncology Nurse Training Course (AONTC)Other
4 weeks and includes 8 days of Advanced Oncology Nurse Training Course
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy Special Training Course (ISTC) | Experimental | 16 weeks and includes 8 hours of digital media training and 2 days of workshop training. Receives: Other: Immunotherapy Special Training Course (ISTC) |
| Advanced Oncology Nurse Training Course (AONTC) | Experimental | 4 weeks and includes 8 days of Advanced Oncology Nurse Training Course. Receives: Other: Advanced Oncology Nurse Training Course (AONTC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Educational needs
Oncology nurses' educational needs for immunotherapy will be assesed qualitative method.
Measured: 1 time points:first time is before the training course
Secondary outcomes (3)
Communication ability scale
Oncology nurses' communication skills were measured by communication ability scale.It is a 5 Liker scale(1-5),higher scores represent better communication skills
Measured: 2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
Self efficacy scale
Oncology nurses' self efficacy will measure by Self efficacy scale.It is a 11 point (0-10) scale.The higher the score, the more confident you are in caring for immunotherapy patients or their families.
Measured: 2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
Critical Thinking test
Effects of oncology nurses received immunization course will measure by Critical Thinking test .It is a 6 Liker scale (1-6) ,the higher score indicates that the participant the better the ability to think critically.
Measured: 2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start28 Apr 2021
- Primary completion23 Nov 2021
- Study completion19 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750199
- Sponsor's protocol ID
- 201912255RINC
- Status last verified
- Aug 2023
- First submitted
- 6 Jan 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of "Multi-Immunotherapy Special Training Courses Through Digital Media and Workshop" Intervention for Oncology Nurses: Exploration of Educational Needs, Curriculum Planning, Implementation and Evaluation
- ClinicalTrials.gov ID
- NCT05750199
- Acronym / sponsor ID
- 201912255RINC
- Keywords
- cancer, immunotherapy, oncology nurse, education need, training course
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 1 Mar 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 is a 2-year qualitative and quantitative mixed method research project and consists of two phases.The study will provide useful clinical data to help us better understand educational needs of immunotherapy for oncology nurses. This ISTC model will lead to further validation of an oncology care training course model designed to better prepare and support cancer patients and their families to existing and new anti-cancer therapies.
Detailed description
Background: More and more cancer patients are receiving immunotherapy. However, patients and their families are overwhelmingly not fully aware of the side effects of immunotherapy or the related management involved while simultaneously experiencing both financial and spiritual burden. Thus, educating the needs of immunotherapy and the development and planning of immunotherapy-related training courses for oncology nurses are necessary.
Purpose: (1) To explore the educational needs for immunotherapy in oncology nurses. (2) To develop and evaluate the effectiveness of "Multi-Immunotherapy Special Training Courses through Digital Media and Workshop" intervention" (short for Immunotherapy Special Training Course (ISTC)" on immunotherapy related care indicators and the feasibility of the ISTC.
Method: This study is a 2-year qualitative and quantitative mixed method research project and consists of two phases: (1) The qualitative method will be conducted using phenomenological methods and snowball sampling. In-depth interviews and observations by one researcher will be adopted in this study. The sample size is determined as the number of samples collected until saturated data analysis is achieved. (2) The quantitative method will be conducted as a quasi-experimental research with a two group pretest-posttest. For the experimental group, snowball sampling will be used to recruit participants who are recommended by a cooperative teaching hospital in the North, Central, South and East Districts of Taiwan to participate in the ISTC training. The duration is to last 16 weeks and includes 8 hours of digital media training and 2 days of workshop training. For the control group, convenient sampling will be used to recruit participants attending the "Advanced Oncology Nurse Training Course (AONTC) (during 4 weeks, 8 days)." which will be held by the Taiwan Oncology Nursing Society. Each group will be followed for 3 to 4 months and their outcomes will be assessed at 3 time points: baseline (pre-training course), and 8, 12 weeks after the training course, T0-T2, respectively. Outcomes will be evaluated based on immunotherapy knowledge, self-efficacy of caring responsible for patients undergoing immunotherapy, critical thinking ability, and ability of communication. Additionally, in the experimental group, outcomes will also be evaluated by mini-clinical evaluation exercise, mini-CEX at T2 and learning passport at 16 weeks after training course (T3). Estimated subject number would be 60 for each group. Results would be analyzed mainly by GEE. After obtaining approval from the institutional review board of a medical center in northern Taiwan and getting the required consent, this study will commence.
Predicted results: The study will provide useful clinical data to help us better understand educational needs of immunotherapy for oncology nurses. This ISTC model will lead to further validation of an oncology care training course model designed to better prepare and support cancer patients and their families to existing and new anti-cancer therapies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy Special Training Course (ISTC) | Experimental | Other: Immunotherapy Special Training Course (ISTC)16 weeks and includes 8 hours of digital media training and 2 days of workshop training. |
| Advanced Oncology Nurse Training Course (AONTC) | Experimental | Other: Advanced Oncology Nurse Training Course (AONTC)4 weeks and includes 8 days of Advanced Oncology Nurse Training Course. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 20 years old (inclusive).
- Nurses or case managers who have completed the training of oncology nursing courses in their hospitals.
- Caring experiences of cancer patients who undergoing immunotherapy.
- The working experience of the oncology unit is at least 1 years.
Key exclusion criteria (1 listed)
- 1. Those who are unwilling or unable to participate in the full four-month course training.
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 |
|---|---|---|
| Immunotherapy Special Training Course (ISTC)16 weeks and includes 8 hours of digital media training and 2 days of workshop training. | Other | Immunotherapy Special Training Course (ISTC) |
| Advanced Oncology Nurse Training Course (AONTC)4 weeks and includes 8 days of Advanced Oncology Nurse Training Course | Other | Advanced Oncology Nurse Training Course (AONTC) |
Primary outcome
Educational needs
Time frame: 1 time points:first time is before the training course
Oncology nurses' educational needs for immunotherapy will be assesed qualitative method.
3 secondary outcomes
Communication ability scale
Time frame: 2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
Self efficacy scale
Time frame: 2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
Critical Thinking test
Time frame: 2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
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 16 Aug 2023.
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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 Immunotherapy Special Training Course (ISTC) and Advanced Oncology Nurse Training Course (AONTC) in people with Education and Oncology, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 1 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 16 Aug 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 Taiwan. 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?
Educational needs (time frame: 1 time points:first time is before the training course). 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 16 Aug 2023.