NCT01275872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

January 12, 2011

Last Update Submit

October 31, 2011

Conditions

Breast CancerProstate Cancer

Keywords

guided imageryprogressive muscle relaxationcomplimentary and alternative medicinequality of lifestresspainanxiety

Outcome Measures

Primary Outcomes (1)

  • Stress

    Saliva α-amylase and saliva cortisol

    20 months

Secondary Outcomes (6)

  • Quality of Life

    20 months

  • Fatigue

    20 months

  • Anxiety

    20 months

  • Depression

    20 months

  • Nausea-vomit

    20 months

  • +1 more secondary outcomes

Study Arms (1)

Guided Imagery and Progressive Muscle Relaxation

EXPERIMENTAL
Other: Guided Imagery and Progressive Muscle Relaxation

Interventions

Guided Imagery and Progressive Muscle RelaxationOTHER

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

Guided Imagery and Progressive Muscle Relaxation

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Use of cortisone
  • Xerostomia
  • oral mucositis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bank of Cyprus Oncology Centre

Nicosia, Nicosia, 2006, Cyprus

Location

Related Publications (2)

  • 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.

    PMID: 30679301DERIVED

  • 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.

    PMID: 27341675DERIVED

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsPainAnxiety Disorders

Interventions

Imagery, PsychotherapyAutogenic Training

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesHypnosis

Study Officials

  • Andreas I Charalambous, PhD

    Cyprus University of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer-Researcher

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

April 1, 2010

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

November 1, 2011

Record last verified: 2011-10

Locations

CY(1)