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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

Primary Purpose

Breast Cancer, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Guided Imagery and Progressive Muscle Relaxation
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring guided imagery, progressive muscle relaxation, complimentary and alternative medicine, quality of life, stress, pain, anxiety

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bank of Cyprus Oncology Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Guided Imagery and Progressive Muscle Relaxation

Arm Description

Outcomes

Primary Outcome Measures

Stress
Saliva α-amylase and saliva cortisol

Secondary Outcome Measures

Quality of Life
Fatigue
Anxiety
Depression
Nausea-vomit
Pain

Full Information

First Posted
January 12, 2011
Last Updated
October 31, 2011
Sponsor
Cyprus University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01275872
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer
Keywords
guided imagery, progressive muscle relaxation, complimentary and alternative medicine, quality of life, stress, pain, anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guided Imagery and Progressive Muscle Relaxation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Guided Imagery and Progressive Muscle Relaxation
Intervention Description
4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions
Primary Outcome Measure Information:
Title
Stress
Description
Saliva α-amylase and saliva cortisol
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
20 months
Title
Fatigue
Time Frame
20 months
Title
Anxiety
Time Frame
20 months
Title
Depression
Time Frame
20 months
Title
Nausea-vomit
Time Frame
20 months
Title
Pain
Time Frame
20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas I Charalambous, PhD
Organizational Affiliation
Cyprus University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bank of Cyprus Oncology Centre
City
Nicosia
ZIP/Postal Code
2006
Country
Cyprus

12. IPD Sharing Statement

Citations:
PubMed Identifier
30679301
Citation
Charalambous A, Giannakopoulou M, Bozas E, Paikousis L. Parallel and serial mediation analysis between pain, anxiety, depression, fatigue and nausea, vomiting and retching within a randomised controlled trial in patients with breast and prostate cancer. BMJ Open. 2019 Jan 24;9(1):e026809. doi: 10.1136/bmjopen-2018-026809.
Results Reference
derived
PubMed Identifier
27341675
Citation
Charalambous A, Giannakopoulou M, Bozas E, Marcou Y, Kitsios P, Paikousis L. Guided Imagery And Progressive Muscle Relaxation as a Cluster of Symptoms Management Intervention in Patients Receiving Chemotherapy: A Randomized Control Trial. PLoS One. 2016 Jun 24;11(6):e0156911. doi: 10.1371/journal.pone.0156911. eCollection 2016.
Results Reference
derived

Learn more about this trial

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

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