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

NCT ID: NCT01275872

Last Updated: 2011-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Guided Imagery and Progressive Muscle Relaxation

Group Type EXPERIMENTAL

Guided Imagery and Progressive Muscle Relaxation

Intervention Type OTHER

4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions

Interventions

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Guided Imagery and Progressive Muscle Relaxation

4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cyprus University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Dr. Andreas Charalambous

Lecturer-Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas I Charalambous, PhD

Role: PRINCIPAL_INVESTIGATOR

Cyprus University of Technology

Locations

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Bank of Cyprus Oncology Centre

Nicosia, Nicosia, Cyprus

Site Status

Countries

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Cyprus

References

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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.

Reference Type DERIVED
PMID: 30679301 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27341675 (View on PubMed)

Other Identifiers

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AC-GIPMR-85

Identifier Type: -

Identifier Source: org_study_id