Guided Imagery & Music in Cancer

NCT ID: NCT03936075

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer, Breast Cancer, Metastatic Cancer Ovaries Cancer Uterus Cervix

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two randomised groups, one intervention group and one placebo group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

the Guided Imagery and Music method

Intervention Type 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

control

standard care treatment with psychometric questionnaires collection and two individual counselling sessions, at baseline (week 1) and at the end (week 6)

Group Type PLACEBO_COMPARATOR

standard care and verbal counselling

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

standard care and verbal counselling

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

receptive music psychotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aretaieion University Hospital

OTHER

Sponsor Role collaborator

SONORA Organisation for Music Therapy and Research

UNKNOWN

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Evangelia Papanikolaou

Evangelia Papanikolaou, music therapist, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Niels Hannibal, PhD

Role: STUDY_DIRECTOR

Aalborg University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aretaieion University Hospital

Athens, Attica, Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

62/19-06-18

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.