Guided Imagery & Music in Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer, Breast, Cancer, Metastatic, Cancer Ovaries, Cancer Uterus Cervix

Intervention / Treatment
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* Behavioral: the Guided Imagery and Music method
* Behavioral: standard care and verbal counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two randomised groups, one intervention group and one placebo group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>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<br>* 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<br>* Other names: receptive music psychotherapy;|
| Placebo Comparator: control<br>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<br>* the participants receive their usual cancer treatment and two individual counselling sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and up to 12 weeks (post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and up to 12 weeks (post-intervention) | 
| 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. | Baseline and up to 12 weeks (post-intervention) | 
| 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) | obtained 6 times throughout the completion of intervention (up to 12 weeks) | 
| Visual Analogue Scale for Fatigue (VAS-F) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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receptive music therapy, Guided Imagery & Music (GIM), chemotherapy, radiotherapy, breast cancer, gynecologic cancer