The Effect of Progressive Relaxation Exercise on Caregiver Burden, Fatigue and Quality of Life in Caregivers of Patients With Advanced Cancer: Randomized Controlled Clinical Study
Primary Purpose
Caregiver Burnout, Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Progressive muscle relaxation
Attention matched control
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burnout focused on measuring Caregiver burden, fatigue, relaxation, quality of life.
Eligibility Criteria
Inclusion Criteria:
- Literate
- Providing care for advanced cancer patients (stage III-IV) for at least 6 months
- Primary caregiver (caring for the longest time)
- No communication problem
- Not using any other non-pharmacological approach during the study period
Exclusion Criteria:
- Providing care for individuals with early-stage (Stage I-II) cancer
- Caregivers who providing care services for a fee
- Having a history of psychiatric disorder (major depression, etc.)
- Not willing to participate in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Relaxation
Attention matched control
Arm Description
Caregivers of patients with advanced cancer will apply 20 minutes of progressive muscle relaxation exercise twice a week, for 8 weeks with a group session.
Caregivers of patients with advanced cancer will receive only a training group session about general cancer information such as risk factors, treatment methods, and treatment-related side effects, lasting 20 minutes first week of the study.
Outcomes
Primary Outcome Measures
Change in caregiver burden severity
Caregiver burden severity will be measured based on patient report by Experience-Based Caregiver Burden Scale in Advanced Cancer.
Maximum scores indicate worse caregiver burden.
Change in fatigue severity
Fatigue severity will be measured based on patient report by the Fatigue Severity Scale. Minimum scores indicate better level of fatigue.
Change in Quality of life status
Quality of life will be measured by the Caregiver's Quality of Life Index-Cancer Scale. Maximum scores indicate better quality of life.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04292678
Brief Title
The Effect of Progressive Relaxation Exercise on Caregiver Burden, Fatigue and Quality of Life in Caregivers of Patients With Advanced Cancer: Randomized Controlled Clinical Study
Official Title
The Effect of Progressive Relaxation Exercise on Caregiver Burden, Fatigue and Quality of Life in Caregivers of Patients With Advanced Cancer: Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Caregivers of patients with advanced cancer will be entered. Participants will be randomized to one of two study arms: Arm 1: Progressive muscle relaxation; Arm 2: Attention matched control. Hypothesis: Progressive muscle relaxation will decrease caregiving burden and severity of fatigue and improve quality of life.
Detailed Description
Previous reports have revealed that progressive muscle relaxation to use to decrease symptom burden associated with cancer. However, there have been limited studies that directly focus on supporting caregivers of advanced cancer patients who face serious problems in diagnosis and treatment process, at least as much as cancer patients. Besides, till date, no study has been conducted to determine the effects of progressive relaxation exercise on caregiver burden, fatigue and quality of life in those providing care for patients with advanced cancer. The present study investigates the effects of progressive muscle relaxation in a single-site, 2-arm, randomized, controlled study of 64 caregivers of patients with advanced cancer. Arm 1: relaxation; Arm 2: Attention matched control. The investigators hypothesize that progressive muscle relaxation will decrease severity of caregiver burden and fatigue and improve quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burnout, Cancer
Keywords
Caregiver burden, fatigue, relaxation, quality of life.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Relaxation
Arm Type
Experimental
Arm Description
Caregivers of patients with advanced cancer will apply 20 minutes of progressive muscle relaxation exercise twice a week, for 8 weeks with a group session.
Arm Title
Attention matched control
Arm Type
Active Comparator
Arm Description
Caregivers of patients with advanced cancer will receive only a training group session about general cancer information such as risk factors, treatment methods, and treatment-related side effects, lasting 20 minutes first week of the study.
Intervention Type
Behavioral
Intervention Name(s)
Progressive muscle relaxation
Intervention Description
The progressive muscle relaxation intervention will last for 20 minutes and comprise sessions involving tensing and relaxing the body with deep breathing. The participants will perform progressive muscle relaxation for each body part in order, starting with the facial muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet; all muscle tension and relaxation procedures were performed accompanied with deep breathing. The participants will be instructed to tense a specified group of muscles for 5 s and relax it for 10 s while breathing out. Throughout this exercise, the participants will visualize a wave of relaxation flowing over their body using the deep-breathing technique.
Intervention Type
Other
Intervention Name(s)
Attention matched control
Intervention Description
Caregivers of patients with advanced cancer will receive only a training group session about general cancer information such as risk factors, treatment methods, and treatment-related side effects, lasting 20 minutes first week of the study.
Primary Outcome Measure Information:
Title
Change in caregiver burden severity
Description
Caregiver burden severity will be measured based on patient report by Experience-Based Caregiver Burden Scale in Advanced Cancer.
Maximum scores indicate worse caregiver burden.
Time Frame
Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
Title
Change in fatigue severity
Description
Fatigue severity will be measured based on patient report by the Fatigue Severity Scale. Minimum scores indicate better level of fatigue.
Time Frame
Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
Title
Change in Quality of life status
Description
Quality of life will be measured by the Caregiver's Quality of Life Index-Cancer Scale. Maximum scores indicate better quality of life.
Time Frame
Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Literate
Providing care for advanced cancer patients (stage III-IV) for at least 6 months
Primary caregiver (caring for the longest time)
No communication problem
Not using any other non-pharmacological approach during the study period
Exclusion Criteria:
Providing care for individuals with early-stage (Stage I-II) cancer
Caregivers who providing care services for a fee
Having a history of psychiatric disorder (major depression, etc.)
Not willing to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Gulbahar, RN,Res.Assis
Phone
+90312 305 15 80/181
Email
gulbaharmerve@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Gulbahar, RN,Res.Assis
Phone
+90 312 305 1580/181
Email
gulbaharmerve@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Gok Metın, Assos.Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Progressive Relaxation Exercise on Caregiver Burden, Fatigue and Quality of Life in Caregivers of Patients With Advanced Cancer: Randomized Controlled Clinical Study
We'll reach out to this number within 24 hrs