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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04292678
Enrollment
64
Registered
2020-03-03
Start date
2020-04-01
Completion date
2021-07-01
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Caregiver Burnout

Keywords

Caregiver burden, fatigue, relaxation, quality of life.

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.

Interventions

BEHAVIORALProgressive 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.

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.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in caregiver burden severityBaseline measurements, at the end of 8th week and two weeks after the completion of the interventionsCaregiver 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 severityBaseline measurements, at the end of 8th week and two weeks after the completion of the interventionsFatigue 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 statusBaseline measurements, at the end of 8th week and two weeks after the completion of the interventionsQuality of life will be measured by the Caregiver's Quality of Life Index-Cancer Scale. Maximum scores indicate better quality of life.

Contacts

Primary ContactMerve Gulbahar, RN,Res.Assis
gulbaharmerve@hotmail.com+90312 305 15 80/181
Backup ContactMerve Gulbahar, RN,Res.Assis
gulbaharmerve@hotmail.com+90 312 305 1580/181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026