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出境医 / 临床实验 / Guided Imagery & Music in Cancer

Guided Imagery & Music in Cancer

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.

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.
Study Design
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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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE July 1, 2018
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		Profiles of Mood States (POMS) [ 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, vigorous, 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). Lower scores indicate better mood states
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • 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.
  • 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.
  • 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)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • 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 indicates a higher hope level with scores ranging from 12 to 48.
  • 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 from 1 to 5. Greater scores correspond to greater fatigue levels.
  • 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)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Guided Imagery & Music in Cancer
Official Title  ICMJE Guided Imagery & Music in Active Treatment for Gynecologic or Breast Cancer: An RCT Pilot
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Cancer, Breast
  • Cancer, Metastatic
  • Cancer Ovaries
  • Cancer Uterus Cervix
Intervention  ICMJE
  • 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
  • Behavioral: standard care and verbal counselling
    the participants receive their usual cancer treatment and two individual counselling sessions
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: the Guided Imagery and Music method
  • 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)
    Intervention: Behavioral: standard care and verbal counselling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 30, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936075
Other Study ID Numbers  ICMJE 62/19-06-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Evangelia Papanikolaou, Aalborg University
Study Sponsor  ICMJE Aalborg University
Collaborators  ICMJE
  • Aretaieion University Hospital
  • SONORA Organisation for Music Therapy and Research
Investigators  ICMJE
Study Director: Niels Hannibal, PhD Aalborg University
PRS Account Aalborg University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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