Music Therapy With Cancer Affected Children and Their Families (INMUT)

March 2, 2023 updated by: Constance Boyde, University of Witten/Herdecke

Interaction-focused Music Therapy With Cancer Affected Children and Their Significant Others: a Randomized Controlled Feasibility Study With Subsequent Intervention (INMUT)

Background: Pediatric oncology patients and their families are in an existentially threatening situation for which music therapy has proven as a cross-linguistic field of action: the creative act of making music offers the possibility of strengthening individual competences and makes socio-psycho-biological conflicts tangible in a very direct way. Although music therapy is an established component of multimodal care and the inclusion of significant others in the therapy setting is recommended, there has been little clinical research on music therapy interaction processes in the family system. The researchers have designed a randomized controlled pilot trial (INMUT) that specifically addresses family interaction in a multi-person setting.

Methods: The examiners investigate the efficacy of music therapy interventions involving the parent-child dyad (INMUT-KB, n=16) compared to music therapy interventions involving only the child (MUT-K, n=16) and a waiting group without intervention (WG, n=10).

Research questions: 1) Does the parent-child interaction improves in mutual attunement, nonverbal communication, and emotional parental response? 2) Are there effects on quality of life, psychosocial and psychosomatic impairments, and system-related level of functioning? Evaluation tools: Primary goals will be assessed by the music therapy-based Assessment of parent-child interaction (APCI) pre and post. The secondary objectives will be assessed by self-reports in form of the psychometric questionnaires KINDL, Experience in Social Systems Questionnaire (EXIS), Burden Assessment Scale (BAS) and Symptom Checklist-K-9 (SCL-9K) pre, post and follow up.

Discussion: The investigators hope for an improvement of the primary and secondary endpoints through participation in music therapy as a basis for a needs-oriented accompaniment of families.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria, Children:

  • cancer diagnosis
  • inpatient (e.g. GKH)
  • no cognitive and auditory dysfunction

Exclusion Criteria, Children:

  • Serious comorbidity with impairment of brain-organic functions
  • BMI<14
  • serious physical comorbidity that does not allow specific assessment of psychosomatic constructs with certainty
  • withdrawal of informed consent

Inclusion Criteria, Important Reference Persons:

- e.g. father, mother, siblings

Exclusion Criteria, Important Reference Persons:

- withdrawal of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)
Interaction-focused music therapy with children with cancer and their significant others, delivered by trained music therapists
Behavioral: Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)
Interaction-focused music therapy with children with cancer and their significant others, delivered by trained music therapists.
Experimental: Music Therapy with Children (MUT-K) (exp. group)
Interaction-focused music therapy with children with cancer without the involvement of significant others, delivered by trained music therapists.
Behavioral: Music Therapy with Children (MUT-K) (exp. group)
Interaction-focused music therapy with children with cancer without the involvement of significant others, delivered by trained music therapists.
Experimental: Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)
Study participants randomized to this group receive the intervention INMUT 10 weeks after the experimental groups.
Behavioral: Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)
Study participants randomized to this group receive the intervention INMUT 10 weeks after the experimental groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Parent-Child Interaction (APCI)
Time Frame: Baseline, Change in 10th hour of intervention
The APCI captures child-reference interaction using mutual attunement, nonverbal communication, and emotional parental response. The diagnostic music therapy intervention sessions are conducted and evaluated by external, blinded, APCI-certified raters.
Baseline, Change in 10th hour of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KINDL-Children/YouthVersion, Modul Oncology
Time Frame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
The KINDL uses 40 items to assess the psychological well-being, social relationships, physical functioning, and daily activities during the daily activities within the last week.
Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
Symptom Checklist-K-9 (SCL-9k)
Time Frame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
The "Short Form Symptom Checklist" (SCL-9k) captures impairment using 9 statements about somatization, obsessiveness, social insecurity, depressiveness, anxiety, aggressiveness, phobic anxiety, paranoia, and psychoticism.
Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
Experience in Social Systems Questionnaire (EXIS)
Time Frame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
EXIS, the "Questionnaire on Experience in Private Social Systems", measures on basis of 12 items the degree of belonging, autonomy, accord, and confidence in the social system described as important within the past 2 weeks.
Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
Burden Assessment Scale (BAS)
Time Frame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
The BAS uses 19 items to survey personal stress, feelings of guilt, the need to interrupt and postpone important matters, and a changed and altered perspective of time in relation to the symptoms displayed by the ill relatives within the last 6 months.
Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
Wittener Ressources Questionnaire (WIRF)
Time Frame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
WIRF captures resources on the basis of three domains of coping with general life experiences, difficult situations in the past, and current problems, using 12 items each. We will use the domain of coping with general life esperiences.
Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
Goal Attainement Scale (GAS)
Time Frame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
GAS captures in free text the subjective goals of children and their significant others. These are classified using the Bern Inventory for Therapy (BIT-T): (1) coping with specific problems and symptoms, (2) interpersonal goals, (3) well-being, (4) existential issues, (5) personal growth, (6) residual category.
Baseline, Change in 10th hour of intervention, Change in 3 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Witten/Herdecke

Collaborators

Heidehof Foundation Stuttgart
Community Hospital Herdecke
Nordoff/Robbins Music Therapy Center Witten
Interprofessional Graduate Programm in Integrative Medicine IGIM

Investigators

  • Principal Investigator: Alfred Längler, Prof. Dr., Gemeinschaftskrankenhaus Herdecke
  • Principal Investigator: Dominik Schneider, Prof. Dr., Klinikum Dortmund
  • Principal Investigator: Michael Paulussen, Prof. Dr., Vestische Kinderklinik Datteln

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

November 30, 2024

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 9, 2022

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INMUT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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