Music Therapy With Cancer Affected Children and Their Families

Pediatric Cancer Clinical Trial

— INMUT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05534282
• Other study ID #: INMUT
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2024
• Source: University of Witten/Herdecke
• Contact: Constance Boyde, cand. Dr.
• Phone: 0049-2302/9267738
• Email: constance.boyde[@]uni-wh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: November 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Vestische Kinderklinik Datteln	Datteln
Germany	Klinikum Dortmund	Dortmund
Germany	Gemeinschaftskrankenhaus Herdecke	Herdecke

Sponsors (5)

Lead Sponsor	Collaborator
University of Witten/Herdecke	Community Hospital Herdecke, Heidehof Foundation Stuttgart, Interprofessional Graduate Programm in Integrative Medicine IGIM, Nordoff/Robbins Music Therapy Center Witten

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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. — View 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. — View 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. — View 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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Parent-Child Interaction (APCI)	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	KINDL-Children/YouthVersion, Modul Oncology	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
Secondary	Symptom Checklist-K-9 (SCL-9k)	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
Secondary	Experience in Social Systems Questionnaire (EXIS)	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
Secondary	Burden Assessment Scale (BAS)	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
Secondary	Wittener Ressources Questionnaire (WIRF)	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
Secondary	Goal Attainement Scale (GAS)	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