Guided Imagery & Music in Cancer

Not Applicable

• Conditions: Cancer, Breast; Cancer Ovaries; Cancer Uterus Cervix; Cancer, Metastatic
• Interventions: Behavioral: the Guided Imagery and Music method; Behavioral: standard care and verbal counselling

• Registration Number: NCT03936075
• Lead Sponsor: Aalborg University

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 Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-03
• Primary Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	the Guided Imagery and Music method	treatment with the provision of 6 individual sessions of the Guided Imagery and Music method as a psychological supportive intervention, and psychometric questionnaires collection
control	standard care and verbal counselling	standard care treatment with psychometric questionnaires collection and two individual counselling sessions, at baseline (week 1) and at the end (week 6)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Aretaieion University Hospital; 🇬🇷 Athens, Attiki, Greece