Guided Imagery & Music in Cancer

July 7, 2020 updated by: Evangelia Papanikolaou, Aalborg University

Guided Imagery & Music in Active Treatment for Gynecologic or Breast Cancer: An RCT Pilot

This is an RCT pilot study to explore the potential effects of the Guided Imagery & Music method for women with breast or gynecologic cancer, during active treatment. The study explores the potential impact in quality of life parameters such as mood, fatigue, and hope.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Guided Imagery and Music is a music-assisted psychotherapy method which has been used as a complementary, supportive psychosocial therapy in cancer care. However, its effects have never been explored during the period of active chemotherapy or radiotherapy treatment in various cancer populations, and especially gynecologic and breast cancer. This pilot study is an effort to explore the feasibility of the method to increase quality of life in this population by possibly reducing side-effects of treatment such as fatigue, improving mood, and building resilience as expressed through levels of hope.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 11528
        • ARETAIEION University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Speaking Greek
  • receiving chemotherapy or radiotherapy treatment for breast or gynecologic cancer
  • first occurrence or metastatic
  • have an interest in engaging in creative psychotherapies through music

Exclusion Criteria:

  • women with active psychosis or PTSD symptomatology
  • women receiving other psychological support
  • women too ill to participate according to doctors' instructions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: intervention
treatment with the provision of 6 individual sessions of the Guided Imagery and Music method as a psychological supportive intervention, and psychometric questionnaires collection
Behavioral: the Guided Imagery and Music method
the method involves listening to the music while describing the experience to the therapist, any visual imagery that is evoked by the music, emotions, body sensations, thoughts or memories. after the music listening session, there is discussion upon making meaning of the experience and finding resources as potential coping skills
Other Names:
  • receptive music psychotherapy
PLACEBO_COMPARATOR: control
standard care treatment with psychometric questionnaires collection and two individual counselling sessions, at baseline (week 1) and at the end (week 6)
Behavioral: standard care and verbal counselling
the participants receive their usual cancer treatment and two individual counselling sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profiles of Mood States (POMS) Brief version (adapted)
Time Frame: Baseline and up to 12 weeks (post-intervention)
Brief version adapted in Greek. A 30-item scale designed to assess six different moods namely tension, anger, vigor, fatigue, depression, confusion. It requires to indicate mood state over the last week, with a single word, each item ranging from 0(not at all) to 4 (extremely). The questionnaire is a sum of its 6 sub scales (each addressing the aforementioned moods), with a total score from 0 to 120. Lower scores indicate better mood states.
Baseline and up to 12 weeks (post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Herth Hope Index
Time Frame: Baseline and up to 12 weeks (post-intervention)
A 12-item Likert-format instrument assessing current levels of hope from 1(strongly disagree) to 4 (strongly agree). It consists of three sub scales, examining interconnectedness, temporality and spirituality, and positiveness or expectancy. A higher score of the sum or the 3 sub scales indicates a higher hope level with scores ranging from 12 to 48.
Baseline and up to 12 weeks (post-intervention)
Cancer-related Fatigue Scale (CFS)
Time Frame: Baseline and up to 12 weeks (post-intervention)
An instrument consisting of 15 items that assess physical, affective, and cognitive dimensions of fatigue at present moment, with Likert scales ranging from 1 to 5. the physical sub scale consists of 7 items, the affective sub scale consists of 4 items, and the cognitive sub scale consists of 3 items and the total of all 3 sub scales indicate that greater scores correspond to greater fatigue levels.
Baseline and up to 12 weeks (post-intervention)
Visual Analogue Scale for Hope (VAS-H)
Time Frame: obtained 6 times throughout the completion of intervention (up to 12 weeks)
VAS is a single, frequent measurement to address the current levels of hope. Its s based on a 100cm horizontal line from 1cm (hopeless) to 100cm (hopeful)
obtained 6 times throughout the completion of intervention (up to 12 weeks)
Visual Analogue Scale for Fatigue (VAS-F)
Time Frame: Obtained 6 times throughout the completion of intervention (up to 12 weeks)
VAS is a single, frequent measurement to address the current levels of fatigue.
Obtained 6 times throughout the completion of intervention (up to 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Collaborators

Aretaieion University Hospital
SONORA Organisation for Music Therapy and Research

Investigators

  • Study Director: Niels Hannibal, PhD, Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2018

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (ACTUAL)

May 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62/19-06-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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