Clinical trial NCT05534282: Music Therapy With Cancer Affected Children and Their Families
Official title: Interaction-focused Music Therapy With Cancer Affected Children and Their Significant Others: a Randomized Controlled Feasibility Study With Subsequent Intervention (INMUT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: pediatrics oncology
music therapy
children
family
significant others
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
Collaborators: name: Heidehof Foundation Stuttgart
name: Community Hospital Herdecke
name: Nordoff/Robbins Music Therapy Center Witten
name: Interprofessional Graduate Programm in Integrative Medicine IGIM
First posted: 2022-09-09
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of Parent-Child Interaction (APCI)
timeFrame: Baseline, Change in 10th hour of intervention
Secondary outcomes:
measure: KINDL-Children/YouthVersion, Modul Oncology
timeFrame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
measure: Symptom Checklist-K-9 (SCL-9k)
timeFrame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
measure: Experience in Social Systems Questionnaire (EXIS)
timeFrame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
measure: Burden Assessment Scale (BAS)
timeFrame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
measure: Wittener Ressources Questionnaire (WIRF)
timeFrame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
measure: Goal Attainement Scale (GAS)
timeFrame: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
Other outcomes:
Locations:
city: Datteln
country: Germany
facility: Vestische Kinderklinik Datteln
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Herdecke
country: Germany
facility: Gemeinschaftskrankenhaus Herdecke
Study officials:
affiliation: Gemeinschaftskrankenhaus Herdecke
name: Alfred Längler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Dortmund
name: Dominik Schneider, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vestische Kinderklinik Datteln
name: Michael Paulussen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.