Clinical trial NCT04292678: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caregiver Burnout
Cancer
Keywords: Caregiver burden, fatigue, relaxation, quality of life.
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in caregiver burden severity
timeFrame: Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
measure: Change in fatigue severity
timeFrame: Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
measure: Change in Quality of life status
timeFrame: Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Zehra Gok Metın, Assos.Prof.
role: STUDY_DIRECTOR
References: