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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04292678
• Other study ID #: N/Y
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2020
• Source: Hacettepe University
• Contact: Merve Gulbahar, RN,Res.Assis
• Phone: +90312 305 15 80/181
• Email: gulbaharmerve[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: July 1, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Psychological
• Cancer
• Caregiver Burnout
• Fatigue

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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