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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.

Primary Purpose

Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer Patients

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Educational sessions
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer Patients focused on measuring Caregiver, Caregiving reactions, Colorectal cancer, Family member, Educational program

Eligibility Criteria

18 Years - 56 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ankara University Graduate School of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 21, 2021
Last Updated
March 9, 2021
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT04791982
Brief Title
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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 18, 2018 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evaluation of the Effects of Education Provided on Family Members Caring for Colorectal Cancer Patients
Keywords
Caregiver, Caregiving reactions, Colorectal cancer, Family member, Educational program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Educational sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effects of education provided to family members caring for colorectal cancer patients receiving chemotherapy on Healthy Lifestyle Behaviors Scale.
Description
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.
Time Frame
through study completion, an average of 1 year.
Title
The effects of education provided to family members caring for colorectal cancer patients receiving chemotherapy on Caregiver Reaction Assessment Scala.
Description
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.
Time Frame
through study completion, an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ankara University Graduate School of Health Sciences
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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.

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