Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer PatientsNCT04791982
The Effect of Education Provided to Family Members Caring for Colorectal Cancer Patients on Caregiving Reactions and Healthy Lifestyle Behaviors: A Prospective Quasi-experimental Study.
A study testing Educational sessions in people with Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer Patients, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The effect of education provided to family members caring for colorectal cancer patients on caregiving reactions and healthy lifestyle behaviors: A prospective quasi-experimental study Read more about this study
- Who is it for?
- Ages 18 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer Patients
- What is being tested?
- Educational sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Aug 2018to 20 May 2019
- 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 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caregivers who committed to providing care to their patients diagnosed with Stage II/III CRC and agreed to participate in the study, and who were suitable to respond to the forms in terms of cognitive and mental health were included in the study.
Who cannot join
- Caregivers whose patients had previously received chemotherapy for CRC or had colostomy in their patients and who had previously been education on the subject were excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Graduate School of Health Sciences
Ankara, 06110
About this study
Official title: The Study Was Conducted as a Pre-test-post-test, Control Group and Quasi-experimental Intervention Research Design in Order to Evaluate the Effects of Education Applied to Family Members Who Provide Care for Patients With Colorectal Cancer on Their Healthy Lifestyle Behaviors and Reactions Towards Caregiving. The Study Population Consisted of 100 Caregiver Who Provide Primary Care to Patients With Colorectal Cancer.
The effect of education provided to family members caring for colorectal cancer patients on caregiving reactions and healthy lifestyle behaviors: A prospective quasi-experimental study
Read the detailed description
The study was conducted as a pre-test-post-test, control group and quasi-experimental intervention research design in order to evaluate the effects of education applied to family members who provide care for patients with colorectal cancer on their healthy lifestyle behaviors and reactions towards caregiving. The study population consisted of 100 caregiver who provide primary care to patients with colorectal cancer. The study data were collected using the "Socio-Demographic Characteristics Data Collection Form", "Healthy Lifestyle Behaviors Scale II (HPLP-II)" and the "Caregiver Reaction Assessment (CRA)". The pre-test was applied to the experimental and control groups at the first interview. The preferred interview format was a booklet. Three times face to-face individual educational sessions were provided to the experimental group, accompanied by a education booklet. After the third educational session the post-test was applied to the caregivers in the experimental and control groups.
- Being tested
- Educational sessions
- Keywords
- Caregiver, Caregiving reactions, Colorectal cancer, Family member, Educational program
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational sessionsBehavioural
Firstly, the literature was scanned and a education booklet prepared after the opinions of 5 academic nurses, who are experts in the field of oncology, was used. The booklet was included colorectal cancer treatment, symptoms that may develop due to chemotherapy and information on their control, psychosocial support of caregiving family members. Interviews and educational sessions with family members who agreed to participate in the study were held in one-on-one and face-to-face meeting room. These interviews lasted approximately 45 to 60 minutes for each family member. In the interviews, a educational booklet containing information on nutrition, exercise, symptom management, physical aspects of care and disease-specific care was used to present information to caregivers. All of educational sessions were performed by the single researcher.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Behavioral: Educational sessions |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of education provided to family members caring for colorectal cancer patients receiving chemotherapy on Healthy Lifestyle Behaviors Scale.
The change in the scala scores of the Healthy Lifestyle Behaviors Scale after the three face-to-face educational sessions provided to the experimental group accompanied by a education booklet compared to the pre-educational period.
The minimum and maxmimum values of the scala are 52-208 and higher scores mean a better.
Measured: through study completion, an average of 1 year.
The effects of education provided to family members caring for colorectal cancer patients receiving chemotherapy on Caregiver Reaction Assessment Scala.
The change in the scala scores of the Caregiver Reaction Assessment after the three face-to-face educational sessions provided to the experimental group accompanied by a education booklet compared to the pre-educational period.
The minimum and maxmimum values of the scala are 24-120 and higher scores mean a worse.
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start18 Aug 2018
- Primary completion20 Dec 2018
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay Bektaş Akpınar, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791982
- Sponsor's protocol ID
- NBAkpınar
- Status last verified
- Mar 2021
- First submitted
- 21 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study Was Conducted as a Pre-test-post-test, Control Group and Quasi-experimental Intervention Research Design in Order to Evaluate the Effects of Education Applied to Family Members Who Provide Care for Patients With Colorectal Cancer on Their Healthy Lifestyle Behaviors and Reactions Towards Caregiving. The Study Population Consisted of 100 Caregiver Who Provide Primary Care to Patients With Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT04791982
- Acronym / sponsor ID
- NBAkpınar
- Keywords
- Caregiver, Caregiving reactions, Colorectal cancer, Family member, Educational program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 18 Aug 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 10 Mar 2021 (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.
The effect of education provided to family members caring for colorectal cancer patients on caregiving reactions and healthy lifestyle behaviors: A prospective quasi-experimental study
Detailed description
The study was conducted as a pre-test-post-test, control group and quasi-experimental intervention research design in order to evaluate the effects of education applied to family members who provide care for patients with colorectal cancer on their healthy lifestyle behaviors and reactions towards caregiving. The study population consisted of 100 caregiver who provide primary care to patients with colorectal cancer. The study data were collected using the "Socio-Demographic Characteristics Data Collection Form", "Healthy Lifestyle Behaviors Scale II (HPLP-II)" and the "Caregiver Reaction Assessment (CRA)". The pre-test was applied to the experimental and control groups at the first interview. The preferred interview format was a booklet. Three times face to-face individual educational sessions were provided to the experimental group, accompanied by a education booklet. After the third educational session the post-test was applied to the caregivers in the experimental and control groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Educational sessions |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Caregivers who committed to providing care to their patients diagnosed with Stage II/III CRC and agreed to participate in the study, and who were suitable to respond to the forms in terms of cognitive and mental health were included in the study.
Key exclusion criteria (1 listed)
- Caregivers whose patients had previously received chemotherapy for CRC or had colostomy in their patients and who had previously been education on the subject were excluded from 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 |
|---|---|---|
| Educational sessionsFirstly, the literature was scanned and a education booklet prepared after the opinions of 5 academic nurses, who are experts in the field of oncology, was used. The booklet was included colorectal cancer treatment, symptoms that may develop due to chemotherapy and information on their control, psychosocial support of caregiving family members. Interviews and educational sessions with family members who agreed to participate in the study were held in one-on-one and face-to-face meeting room. These interviews lasted approximately 45 to 60 minutes for each family member. In the interviews, a educational booklet containing information on nutrition, exercise, symptom management, physical aspects of care and disease-specific care was used to present information to caregivers. All of educational sessions were performed by the single researcher. | Behavioural | Experimental group |
Primary outcome
The effects of education provided to family members caring for colorectal cancer patients receiving chemotherapy on Healthy Lifestyle Behaviors Scale.
Time frame: through study completion, an average of 1 year.
The change in the scala scores of the Healthy Lifestyle Behaviors Scale after the three face-to-face educational sessions provided to the experimental group accompanied by a education booklet compared to the pre-educational period. The minimum and maxmimum values of the scala are 52-208 and higher scores mean a better.
The effects of education provided to family members caring for colorectal cancer patients receiving chemotherapy on Caregiver Reaction Assessment Scala.
Time frame: through study completion, an average of 1 year.
The change in the scala scores of the Caregiver Reaction Assessment after the three face-to-face educational sessions provided to the experimental group accompanied by a education booklet compared to the pre-educational period. The minimum and maxmimum values of the scala are 24-120 and higher scores mean a worse.
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 Mar 2021.
- Individual participant dataSharing planned: Undecided
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 Educational sessions in people with Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer Patients, run by Ankara 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 1 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 10 Mar 2021. 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?
The effects of education provided to family members caring for colorectal cancer patients receiving chemotherapy on Healthy Lifestyle Behaviors Scale. (time frame: through study completion, an average of 1 year.). 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 10 Mar 2021.