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Completed

NCT Number: 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

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.

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Key information

Conditions

Breast Cancer Anxiety Disorders Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bank of Cyprus Oncology Centre

Nicosia, 2006, Cyprus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guided Imagery and Progressive Muscle Relaxation

Other

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

Primary outcomes

  1. Stress

    Time frame: 20 months

    Saliva α-amylase and saliva cortisol

Secondary outcomes

  1. Quality of Life

    Time frame: 20 months

  2. Fatigue

    Time frame: 20 months

  3. Anxiety

    Time frame: 20 months

  4. Depression

    Time frame: 20 months

  5. Nausea-vomit

    Time frame: 20 months

  6. Pain

    Time frame: 20 months

Sponsors and collaborators

Lead sponsor

Cyprus University of Technology

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2011
Registry last updated
Nov 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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