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
1 other identifier
interventional
64
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedMarch 4, 2020
March 1, 2020
1.1 years
March 1, 2020
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
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.
Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
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.
Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
Study Arms (2)
Relaxation
EXPERIMENTALCaregivers of patients with advanced cancer will apply 20 minutes of progressive muscle relaxation exercise twice a week, for 8 weeks with a group session.
Attention matched control
ACTIVE COMPARATORCaregivers 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zehra Gok Metın, Assos.Prof.
Hacettepe University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
March 1, 2020
First Posted
March 3, 2020
Study Start
April 1, 2020
Primary Completion
April 30, 2021
Study Completion
July 1, 2021
Last Updated
March 4, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share