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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2021

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.

Interventions

  • Behavioral: Progressive muscle relaxation
    • 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.
  • Other: 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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in caregiver burden severity
    • Time Frame: 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.
  • Change in fatigue severity
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hacettepe University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Merve Gulbahar, Research Assistant – Hacettepe University
  • Overall Official(s)
    • Zehra Gok Metın, Assos.Prof., Study Director, Hacettepe University
  • Overall Contact(s)
    • Merve Gulbahar, RN,Res.Assis, +90312 305 15 80/181, gulbaharmerve@hotmail.com

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