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Guided Imagery & Music in Cancer

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ClinicalTrials.gov Identifier: NCT03936075
Recruitment Status : Active, not recruiting
First Posted : May 3, 2019
Last Update Posted : July 8, 2020
Sponsor:
Collaborators:
Aretaieion University Hospital
SONORA Organisation for Music Therapy and Research
Information provided by (Responsible Party):
Evangelia Papanikolaou, Aalborg University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer, Breast Cancer, Metastatic Cancer Ovaries Cancer Uterus Cervix Behavioral: the Guided Imagery and Music method Behavioral: standard care and verbal counselling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two randomised groups, one intervention group and one placebo group
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Guided Imagery & Music in Active Treatment for Gynecologic or Breast Cancer: An RCT Pilot
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)

  4. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936075


Locations
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Greece
Aretaieion University Hospital
Athens, Attiki, Greece, 11528
Sponsors and Collaborators
Aalborg University
Aretaieion University Hospital
SONORA Organisation for Music Therapy and Research
Investigators
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Study Director: Niels Hannibal, PhD Aalborg University
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Responsible Party: Evangelia Papanikolaou, Evangelia Papanikolaou, music therapist, Principal Investigator, Aalborg University
ClinicalTrials.gov Identifier: NCT03936075    
Other Study ID Numbers: 62/19-06-18
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evangelia Papanikolaou, Aalborg University:
receptive music therapy
Guided Imagery & Music (GIM)
chemotherapy
radiotherapy
breast cancer
gynecologic cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases