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Guided Imagery & Music in Cancer

Primary Purpose

Cancer, Breast, Cancer, Metastatic, Cancer Ovaries

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
the Guided Imagery and Music method
standard care and verbal counselling
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Breast focused on measuring receptive music therapy, Guided Imagery & Music (GIM), chemotherapy, radiotherapy, breast cancer, gynecologic cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aretaieion University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

intervention

control

Arm Description

treatment with the provision of 6 individual sessions of the Guided Imagery and Music method as a psychological supportive intervention, and psychometric questionnaires collection

standard care treatment with psychometric questionnaires collection and two individual counselling sessions, at baseline (week 1) and at the end (week 6)

Outcomes

Primary Outcome Measures

Profiles of Mood States (POMS) Brief version (adapted)
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

Herth Hope Index
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.
Cancer-related Fatigue Scale (CFS)
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.
Visual Analogue Scale for Hope (VAS-H)
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)
Visual Analogue Scale for Fatigue (VAS-F)
VAS is a single, frequent measurement to address the current levels of fatigue.

Full Information

First Posted
April 29, 2019
Last Updated
July 7, 2020
Sponsor
Aalborg University
Collaborators
Aretaieion University Hospital, SONORA Organisation for Music Therapy and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03936075
Brief Title
Guided Imagery & Music in Cancer
Official Title
Guided Imagery & Music in Active Treatment for Gynecologic or Breast Cancer: An RCT Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Aretaieion University Hospital, SONORA Organisation for Music Therapy and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Cancer, Metastatic, Cancer Ovaries, Cancer Uterus Cervix
Keywords
receptive music therapy, Guided Imagery & Music (GIM), chemotherapy, radiotherapy, breast cancer, gynecologic cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two randomised groups, one intervention group and one placebo group
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
treatment with the provision of 6 individual sessions of the Guided Imagery and Music method as a psychological supportive intervention, and psychometric questionnaires collection
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
standard care treatment with psychometric questionnaires collection and two individual counselling sessions, at baseline (week 1) and at the end (week 6)
Intervention Type
Behavioral
Intervention Name(s)
the Guided Imagery and Music method
Other Intervention Name(s)
receptive music psychotherapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
standard care and verbal counselling
Intervention Description
the participants receive their usual cancer treatment and two individual counselling sessions
Primary Outcome Measure Information:
Title
Profiles of Mood States (POMS) Brief version (adapted)
Description
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.
Time Frame
Baseline and up to 12 weeks (post-intervention)
Secondary Outcome Measure Information:
Title
Herth Hope Index
Description
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.
Time Frame
Baseline and up to 12 weeks (post-intervention)
Title
Cancer-related Fatigue Scale (CFS)
Description
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.
Time Frame
Baseline and up to 12 weeks (post-intervention)
Title
Visual Analogue Scale for Hope (VAS-H)
Description
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)
Time Frame
obtained 6 times throughout the completion of intervention (up to 12 weeks)
Title
Visual Analogue Scale for Fatigue (VAS-F)
Description
VAS is a single, frequent measurement to address the current levels of fatigue.
Time Frame
Obtained 6 times throughout the completion of intervention (up to 12 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Hannibal, PhD
Organizational Affiliation
Aalborg University
Official's Role
Study Director
Facility Information:
Facility Name
Aretaieion University Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
11528
Country
Greece

12. IPD Sharing Statement

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Guided Imagery & Music in Cancer

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