Clinical trial NCT01275872: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Prostate Cancer
Keywords: guided imagery
progressive muscle relaxation
complimentary and alternative medicine
quality of life
stress
pain
anxiety
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Stress
timeFrame: 20 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 20 months
measure: Fatigue
timeFrame: 20 months
measure: Anxiety
timeFrame: 20 months
measure: Depression
timeFrame: 20 months
measure: Nausea-vomit
timeFrame: 20 months
measure: Pain
timeFrame: 20 months
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Bank of Cyprus Oncology Centre
Study officials:
affiliation: Cyprus University of Technology
name: Andreas I Charalambous, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.