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.

March 9, 2021 updated by: Nilay Bektaş Akpınar, Ankara University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Ankara University Graduate School of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Experimental group
Behavioral: Educational sessions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2018

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

May 20, 2019

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBAkpınar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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