Music Therapy With Cancer Affected Children and Their Families

NCT05534282 | Recruiting DMC

• 1 other identifier: INMUT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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.

Conditions

Pediatric Cancer

Keywords

pediatrics oncology; music therapy; children; family; significant others

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• KINDL-Children/YouthVersion, Modul Oncology

  Baseline, Change in 10th hour of intervention, Change in 3 months after intervention

• Symptom Checklist-K-9 (SCL-9k)

  Baseline, Change in 10th hour of intervention, Change in 3 months after intervention

• Experience in Social Systems Questionnaire (EXIS)

  Baseline, Change in 10th hour of intervention, Change in 3 months after intervention

• Burden Assessment Scale (BAS)

  Baseline, Change in 10th hour of intervention, Change in 3 months after intervention

• Wittener Ressources Questionnaire (WIRF)

  Baseline, Change in 10th hour of intervention, Change in 3 months after intervention

Study Arms (3)

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

EXPERIMENTAL

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)

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

EXPERIMENTAL

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 and Significant Others (WG-KB) (control group)

EXPERIMENTAL

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)

Interventions

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

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

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

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

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

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

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

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

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

Eligibility Criteria

• Age: 5 Years - 13 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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
• \- e.g. father, mother, siblings
• \- withdrawal of consent

Sponsors & Collaborators

• University of Witten/Herdecke: lead
• Heidehof Foundation Stuttgart: collaborator
• Community Hospital Herdecke: collaborator
• Nordoff/Robbins Music Therapy Center Witten: collaborator
• Interprofessional Graduate Programm in Integrative Medicine IGIM: collaborator

Study Sites (3)

Vestische Kinderklinik Datteln

Datteln, 45711, Germany

RECRUITING

Klinikum Dortmund

Dortmund, 44137, Germany

RECRUITING

Gemeinschaftskrankenhaus Herdecke

Herdecke, 58313, Germany

RECRUITING

Related Publications (6)

• 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.

  PMID: 31657011 BACKGROUND

• 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.

  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.

  PMID: 26858173 BACKGROUND

• 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.

  PMID: 27257528 BACKGROUND

• 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.

  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.

  PMID: 38807165 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Music Therapy; Control Groups

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Alfred Längler, Prof. Dr.

  Gemeinschaftskrankenhaus Herdecke

  PRINCIPAL INVESTIGATOR

• Dominik Schneider, Prof. Dr.

  Klinikum Dortmund

  PRINCIPAL INVESTIGATOR

• Michael Paulussen, Prof. Dr.

  Vestische Kinderklinik Datteln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Constance Boyde, cand. Dr.

CONTACT

0049-2302/9267738; constance.boyde@uni-wh.de

Christina Hunger-Schoppe, Prof. Dr.

CONTACT

0049-2302/9267907; christina.hunger-schoppe@uni-wh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cand. Dr.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: September 9, 2022
• Study Start: March 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: November 30, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)