Effect of Guided Imagery and Progressive Muscle Relaxation as a Means to Improve the Psychological Well-being and the Quality of Life for Patients With Breast and Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT01275872
First received: January 12, 2011
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to determine whether Guided Imagery and Progressive Muscle Relaxation techniques are effective in the management of pain, fatigue, nausea-vomit, anxiety and depression in patients with either prostate or breast cancer.

This study includes a total of 200 patients with prostate and breast cancer randomly assigned to either a control or intervention group.

The intervention group received in total 4 sessions of Guided Imagery (protocol floating on a cloud) and Progressive Muscle Relaxation (breathing exercises and use of 11 groups of muscle progressively tensing and relaxing).

Measurements included the assessment of pain, fatigue, nausea-vomit, depression, anxiety and quality of life. Additionally, saliva samples were collected prior and after the sessions as to assess saliva cortisol and saliva α-amylase.

The same measurements were received by the patients of the control group as to allow comparisons.


Condition Intervention
Breast Cancer
Prostate Cancer
Other: Guided Imagery and Progressive Muscle Relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Clinical Trial on the Effect of Guided Imagery and Progressive Muscle Relaxation for the Management of Pain, Stress, Anxiety and Depression as a Means to Improve the Psychological Well-being and the Quality of Life for Patients With Breast and Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Cyprus University of Technology:

Primary Outcome Measures:
  • Stress [ Time Frame: 20 months ] [ Designated as safety issue: No ]
    Saliva α-amylase and saliva cortisol


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Fatigue [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Nausea-vomit [ Time Frame: 20 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 20 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guided Imagery and Progressive Muscle Relaxation Other: Guided Imagery and Progressive Muscle Relaxation
4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of breast or prostate cancer
  • Must be able to follow instructions
  • Good cognitive ability
  • Willing to participate

Exclusion Criteria:

  • Use of cortisone
  • Xerostomia
  • oral mucositis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275872

Locations
Cyprus
Bank of Cyprus Oncology Centre
Nicosia, Cyprus, 2006
Sponsors and Collaborators
Cyprus University of Technology
Investigators
Principal Investigator: Andreas I Charalambous, PhD Cyprus University of Technology
  More Information

No publications provided

Responsible Party: Dr. Andreas Charalambous, Lecturer-Researcher, Cyprus University of Technology
ClinicalTrials.gov Identifier: NCT01275872     History of Changes
Other Study ID Numbers: AC-GIPMR-85
Study First Received: January 12, 2011
Last Updated: October 31, 2011
Health Authority: Cyprus: Cyprus National Bio-Ethics Committee

Keywords provided by Cyprus University of Technology:
guided imagery
progressive muscle relaxation
complimentary and alternative medicine
quality of life
stress
pain
anxiety

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014