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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275872
• Other study ID #: AC-GIPMR-85
• Status: Completed
• Phase: N/A
• First received: January 12, 2011
• Last updated: October 31, 2011
• Start date: April 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: Cyprus University of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cyprus: Cyprus National Bio-Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Guided Imagery and Progressive Muscle Relaxation
4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions

Locations

Country	Name	City	State
Cyprus	Bank of Cyprus Oncology Centre	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
Cyprus University of Technology

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress	Saliva a-amylase and saliva cortisol	20 months	No
Secondary	Quality of Life		20 months	No
Secondary	Fatigue		20 months	No
Secondary	Anxiety		20 months	No
Secondary	Depression		20 months	No
Secondary	Nausea-vomit		20 months	No
Secondary	Pain		20 months	No