Guided Imagery & Music in Cancer

Sponsor

Aalborg University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03936075

Collaborator

Aretaieion University Hospital (Other), SONORA Organisation for Music Therapy and Research (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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	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

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two randomised groups, one intervention group and one placebo grouptwo 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 :

Jul 1, 2018

Actual Primary Completion Date :

Jun 30, 2020

Anticipated Study Completion Date :

Dec 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 Names: 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

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 Names:

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

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

Herth Hope Index [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) [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) [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) [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

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts 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