Breast CancerNCT01275872
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
A study testing Guided Imagery and Progressive Muscle Relaxation in people with Breast Cancer and Prostate Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Breast Cancer, Prostate Cancer
- What is being tested?
- Guided Imagery and Progressive Muscle Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCyprus
- Study dates
- Apr 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of breast or prostate cancer
- Must be able to follow instructions
- Good cognitive ability
- Willing to participate
Who cannot join
- Use of cortisone
- Xerostomia
- oral mucositis
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Breast Cancer, Prostate Cancer
- Being tested
- Guided Imagery and Progressive Muscle Relaxation
- Keywords
- guided imagery, progressive muscle relaxation, complimentary and alternative medicine, quality of life, stress, pain, anxiety
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Imagery and Progressive Muscle RelaxationOther
4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery and Progressive Muscle Relaxation | Experimental | Not described Receives: Other: Guided Imagery and Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Saliva α-amylase and saliva cortisol
Measured: 20 months
Secondary outcomes (6)
Quality of Life
Measured: 20 months
Fatigue
Measured: 20 months
Anxiety
Measured: 20 months
Depression
Measured: 20 months
Nausea-vomit
Measured: 20 months
Pain
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andreas Charalambous, Cyprus University of Technology
- Investigators
- Andreas I Charalambous, PhD, Principal investigator, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275872
- Sponsor's protocol ID
- AC-GIPMR-85
- Status last verified
- Oct 2011
- First submitted
- 12 Jan 2011
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30679301Charalambous 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.
PubMed 27341675
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01275872
- Acronym / sponsor ID
- AC-GIPMR-85
- Conditions
- Breast Cancer, Prostate Cancer
- Keywords
- guided imagery, progressive muscle relaxation, complimentary and alternative medicine, quality of life, stress, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery and Progressive Muscle Relaxation | Experimental | Other: Guided Imagery and Progressive Muscle Relaxation |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of breast or prostate cancer
- Must be able to follow instructions
- Good cognitive ability
- Willing to participate
Key exclusion criteria (3 listed)
- Use of cortisone
- Xerostomia
- oral mucositis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided Imagery and Progressive Muscle Relaxation4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions | Other | Guided Imagery and Progressive Muscle Relaxation |
Primary outcome
Stress
Time frame: 20 months
Saliva α-amylase and saliva cortisol
6 secondary outcomes
Quality of Life
Time frame: 20 months
Fatigue
Time frame: 20 months
Anxiety
Time frame: 20 months
Depression
Time frame: 20 months
Nausea-vomit
Time frame: 20 months
Pain
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
- Derived from this study: PubMed 30679301Charalambous 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.
- Derived from this study: PubMed 27341675Charalambous 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas I Charalambous, PhD principal investigator
Cyprus University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery and Progressive Muscle Relaxation in people with Breast Cancer and Prostate Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275872, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2011.