Guided Imagery & Music in Cancer

NCT03936075 | Unknown

• 1 other identifier: 62/19-06-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Breast; Cancer, Metastatic; Cancer Ovaries; Cancer Uterus Cervix

Keywords

receptive music therapy; Guided Imagery & Music (GIM); chemotherapy; radiotherapy; breast cancer; gynecologic cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Herth Hope Index

  Baseline and up to 12 weeks (post-intervention)

• Cancer-related Fatigue Scale (CFS)

  Baseline and up to 12 weeks (post-intervention)

• Visual Analogue Scale for Hope (VAS-H)

  obtained 6 times throughout the completion of intervention (up to 12 weeks)

• Visual Analogue Scale for Fatigue (VAS-F)

  Obtained 6 times throughout the completion of intervention (up to 12 weeks)

Study Arms (2)

intervention

EXPERIMENTAL

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

control

PLACEBO COMPARATOR

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

Interventions

the Guided Imagery and Music method BEHAVIORAL

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

Also known as: receptive music psychotherapy

intervention

standard care and verbal counselling BEHAVIORAL

the participants receive their usual cancer treatment and two individual counselling sessions

control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• women with active psychosis or PTSD symptomatology
• women receiving other psychological support
• women too ill to participate according to doctors' instructions

Sponsors & Collaborators

• Aalborg University: lead
• Aretaieion University Hospital: collaborator
• SONORA Organisation for Music Therapy and Research: collaborator

Study Sites (1)

Aretaieion University Hospital

Athens, Attica, 11528, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Ovarian Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Niels Hannibal, PhD

  Aalborg University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Evangelia Papanikolaou, music therapist, Principal Investigator

Model Details: two randomised groups, one intervention group and one placebo group

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 3, 2019
• Study Start: July 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

GR (1)