search
Back to results

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

Primary Purpose

Caregiver Burnout, Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Progressive muscle relaxation
Attention matched control
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregiver Burnout focused on measuring Caregiver burden, fatigue, relaxation, quality of life.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Relaxation

    Attention matched control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 1, 2020
    Last Updated
    March 2, 2020
    Sponsor
    Hacettepe University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04292678
    Brief 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
    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

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2020 (Anticipated)
    Primary Completion Date
    April 30, 2021 (Anticipated)
    Study Completion Date
    July 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Caregiver Burnout, Cancer
    Keywords
    Caregiver burden, fatigue, relaxation, quality of life.

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Relaxation
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Attention matched control
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Progressive muscle relaxation
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Attention matched control
    Intervention Description
    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 Measure Information:
    Title
    Change in caregiver burden severity
    Description
    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.
    Time Frame
    Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
    Title
    Change in fatigue severity
    Description
    Fatigue severity will be measured based on patient report by the Fatigue Severity Scale. Minimum scores indicate better level of fatigue.
    Time Frame
    Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions
    Title
    Change in Quality of life status
    Description
    Quality of life will be measured by the Caregiver's Quality of Life Index-Cancer Scale. Maximum scores indicate better quality of life.
    Time Frame
    Baseline measurements, at the end of 8th week and two weeks after the completion of the interventions

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Merve Gulbahar, RN,Res.Assis
    Phone
    +90312 305 15 80/181
    Email
    gulbaharmerve@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Merve Gulbahar, RN,Res.Assis
    Phone
    +90 312 305 1580/181
    Email
    gulbaharmerve@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zehra Gok Metın, Assos.Prof.
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

    We'll reach out to this number within 24 hrs