Guided Imagery & Music in Cancer identifier recruitment status First Posted Last update posted
NCT03936075 Active, not recruiting May 3, 2019 July 8, 2020

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: Cancer Ovaries
Cancer Uterus Cervix
Cancer, Breast
Cancer, Metastatic
Intervention/treatment: Behavioral: the Guided Imagery and Music method
Behavioral: standard care and verbal counselling
Phase: N/A
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
Study Type: Interventional
Estimated Enrollment : 20 participants
Intervention Model : Parallel Assignment
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 2018
Estimated Primary Completion Date: June 2020
Actual Study Completion Date: December 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
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
Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

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
Greece, Attiki Aretaieion University Hospital Athens
Sponsors and Collaborators
Aalborg University
Aretaieion University Hospital
SONORA Organisation for Music Therapy and Research
Study Director : Niels Hannibal, PhD Aalborg University
More Information
Responsible Party : Aalborg University Identifier : NCT03936075     
Other Study ID Numbers : 62/19-06-18
First Posted : May 3, 2019
Last Update Posted : July 8, 2020
Last Verified : July 2020
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aalborg University: Guided Imagery & Music (GIM)
gynecologic cancer
breast cancer
receptive music therapy
Additional relevant MeSH terms :
Breast Neoplasms