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

Not Applicable

• Conditions: Cancer; Caregiver Burnout
• Interventions: Behavioral: Progressive muscle relaxation; Other: Attention matched control

• Registration Number: NCT04292678
• Lead Sponsor: Hacettepe University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2020-03-01
• Last Update Submitted: 2020-03-02
• Study First Posted: 2020-03-03
• Last Update Posted: 2020-03-04
• Study Start: 2020-04-01
• Primary Completion: 2021-04-30
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation	Progressive muscle relaxation	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.
Attention matched control	Attention matched control	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 Measures

Name	Time	Method
Change in fatigue severity	Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions	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	Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions	Quality of life will be measured by the Caregiver's Quality of Life Index-Cancer Scale. Maximum scores indicate better quality of life.
Change in caregiver burden severity	Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions	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.