Music Therapy With Cancer Affected Children and Their Families

NCT ID: NCT05534282

Last Updated: 2024-05-09

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)

Intervention Type BEHAVIORAL

Interaction-focused music therapy with children with cancer and their significant others, delivered by trained music therapists.

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.

Group Type EXPERIMENTAL

Music Therapy with Children (MUT-K) (exp. group)

Intervention Type BEHAVIORAL

Interaction-focused music therapy with children with cancer without the involvement of significant others, delivered by trained music therapists.

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.

Group Type EXPERIMENTAL

Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)

Intervention Type BEHAVIORAL

Study participants randomized to this group receive the intervention INMUT 10 weeks after the experimental groups.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


\- e.g. father, mother, siblings

Exclusion Criteria

* 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


\- withdrawal of consent
Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidehof Foundation Stuttgart

UNKNOWN

Sponsor Role collaborator

Community Hospital Herdecke

UNKNOWN

Sponsor Role collaborator

Nordoff/Robbins Music Therapy Center Witten

UNKNOWN

Sponsor Role collaborator

Interprofessional Graduate Programm in Integrative Medicine IGIM

UNKNOWN

Sponsor Role collaborator

University of Witten/Herdecke

OTHER

Sponsor Role lead

Responsible Party

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Constance Boyde

cand. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alfred Längler, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gemeinschaftskrankenhaus Herdecke

Dominik Schneider, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Dortmund

Michael Paulussen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Vestische Kinderklinik Datteln

Locations

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Vestische Kinderklinik Datteln

Datteln, , Germany

Site Status RECRUITING

Klinikum Dortmund

Dortmund, , Germany

Site Status RECRUITING

Gemeinschaftskrankenhaus Herdecke

Herdecke, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Constance Boyde, cand. Dr.

Role: CONTACT

0049-2302/9267738

Christina Hunger-Schoppe, Prof. Dr.

Role: CONTACT

0049-2302/9267907

Facility Contacts

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Michael Paulussen, Prof. Dr.

Role: primary

Dominik Schneider, Prof. Dr.

Role: primary

Alfred Längler, Prof. Dr.

Role: primary

References

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Hunger C, Hilzinger R, Klewinghaus L, Deusser L, Sander A, Mander J, Bents H, Ditzen B, Schweitzer J. Comparing Cognitive Behavioral Therapy and Systemic Therapy for Social Anxiety Disorder: Randomized Controlled Pilot Trial (SOPHO-CBT/ST). Fam Process. 2020 Dec;59(4):1389-1406. doi: 10.1111/famp.12492. Epub 2019 Oct 27.

Reference Type BACKGROUND
PMID: 31657011 (View on PubMed)

Hunger, C. (2020). Familienaufstellung als Einzelintervention im Gruppensetting bei chronisch-psychosozialen Konflikten: Randomisiert-kontrollierte Wirksamkeitsstudie mit Katamnesen von 2 Wochen bis 5 Jahre. Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 68(4), 263-273.

Reference Type BACKGROUND

Hunger C, Bornhauser A, Link L, Geigges J, Voss A, Weinhold J, Schweitzer J. The Experience in Personal Social Systems Questionnaire (EXIS.pers): Development and Psychometric Properties. Fam Process. 2017 Mar;56(1):154-170. doi: 10.1111/famp.12205. Epub 2016 Feb 8.

Reference Type BACKGROUND
PMID: 26858173 (View on PubMed)

Boyde C, Linden U, Boehm K, Ostermann T. The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. Glob Adv Health Med. 2012 Nov;1(5):24-9. doi: 10.7453/gahmj.2012.1.5.009. Epub 2012 Nov 1.

Reference Type BACKGROUND
PMID: 27257528 (View on PubMed)

Ostermann, T., Boyde, C., & Linden, K. (2012). Music therapy in the treatment of cancer patients: A systematic review. BMC Complementary and Alternative Medicine, 12(Suppl1): P327.

Reference Type BACKGROUND

Boyde C, Berger B, Langler A, Neugebauer L, Jacobsen SL, Swanick R, Gaebel C, Schneider D, Bernbeck B, Paulussen M, Ostermann T, Hunger-Schoppe C. Interaction-focused music therapy with cancer-affected children and their significant others: a randomized controlled feasibility study with subsequent intervention (INMUT). Pilot Feasibility Stud. 2024 May 28;10(1):86. doi: 10.1186/s40814-024-01490-8.

Reference Type DERIVED
PMID: 38807165 (View on PubMed)

Other Identifiers

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INMUT

Identifier Type: -

Identifier Source: org_study_id

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