Pediatric CancerINMUTNCT05534282
Music Therapy With Cancer Affected Children and Their Families
A study testing Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group) and Music Therapy with Children (MUT-K) (exp. group) in people with Pediatric Cancer, run by University of Witten/Herdecke at 3 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group) and Music Therapy with Children (MUT-K) (exp. group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Mar 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- cancer diagnosis
- inpatient (e.g. GKH)
- no cognitive and auditory dysfunction
- e.g. father, mother, siblings
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Vestische Kinderklinik Datteln
Datteln, 45711
Michael Paulussen, Prof. Dr., Paulussen Michael <m.paulussen@kinderklinik-datteln.de>
- Recruiting
Klinikum Dortmund
Dortmund, 44137
Dominik Schneider, Prof. Dr., dominik.schneider@klinikumdo.de
- Recruiting
Gemeinschaftskrankenhaus Herdecke
Herdecke, 58313
Alfred Längler, Prof. Dr., a.laengler@gemeinschaftskrankenhaus.de
Alfred Längler, Prof. Dr.
About this study
Official title: 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).
Read more
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
- Being tested
- Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group), Music Therapy with Children (MUT-K) (exp. group), Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group)
- Keywords
- pediatrics oncology, music therapy, children, family, significant others
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group)Behavioural
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)Behavioural
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)Behavioural
Study participants randomized to this group receive the intervention INMUT 10 weeks after the experimental groups.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Behavioral: Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Change in 10th hour of intervention
Secondary outcomes (6)
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.
Measured: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
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.
Measured: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
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.
Measured: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
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.
Measured: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
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.
Measured: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
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.
Measured: Baseline, Change in 10th hour of intervention, Change in 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Mar 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- Heidehof Foundation Stuttgart, Community Hospital Herdecke, Nordoff/Robbins Music Therapy Center Witten, Interprofessional Graduate Programm in Integrative Medicine IGIM
- Responsible party
- Principal investigator, Constance Boyde, University of Witten/Herdecke
- Investigators
- Alfred Längler, Prof. Dr., Principal investigator, Gemeinschaftskrankenhaus HerdeckeDominik Schneider, Prof. Dr., Principal investigator, Klinikum DortmundMichael Paulussen, Prof. Dr., Principal investigator, Vestische Kinderklinik Datteln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534282
- Sponsor's protocol ID
- INMUT
- Acronym
- INMUT
- Status last verified
- May 2024
- First submitted
- 8 Aug 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31657011Hunger, 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.
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.
PubMed 26858173Boyde 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.
PubMed 27257528Ostermann, 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.
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.
PubMed 38807165
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction-focused Music Therapy With Cancer Affected Children and Their Significant Others: a Randomized Controlled Feasibility Study With Subsequent Intervention (INMUT)
- ClinicalTrials.gov ID
- NCT05534282
- Acronym / sponsor ID
- INMUT / INMUT
- Conditions
- Pediatric Cancer
- Keywords
- pediatrics oncology, music therapy, children, family, significant others
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- Heidehof Foundation Stuttgart, Community Hospital Herdecke, Nordoff/Robbins Music Therapy Center Witten, Interprofessional Graduate Programm in Integrative Medicine IGIM
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group) | Experimental | 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) | Experimental | 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. |
| Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group) | Experimental | 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. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- cancer diagnosis
- inpatient (e.g. GKH)
- no cognitive and auditory dysfunction
- e.g. father, mother, siblings
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group) |
| 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. | Behavioural | Music Therapy with Children (MUT-K) (exp. group) |
| 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. | Behavioural | Interaction-focused Music Therapy with Children and Significant Others (WG-KB) (control group) |
Primary outcome
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.
6 secondary outcomes
KINDL-Children/YouthVersion, Modul Oncology
Time frame: 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
Experience in Social Systems Questionnaire (EXIS)
Time frame: 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
Wittener Ressources Questionnaire (WIRF)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 31657011Hunger 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.
- BackgroundHunger, 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: PubMed 26858173Hunger 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.
- Background: PubMed 27257528Boyde 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.
- BackgroundOstermann, 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.
- Derived from this study: PubMed 38807165Boyde 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred Längler, Prof. Dr. principal investigator
Gemeinschaftskrankenhaus Herdecke
Dominik Schneider, Prof. Dr. principal investigator
Klinikum Dortmund
Michael Paulussen, Prof. Dr. principal investigator
Vestische Kinderklinik Datteln
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interaction-focused Music Therapy with Children and Significant Others (INMUT-KB) (exp. group) and Music Therapy with Children (MUT-K) (exp. group) in people with Pediatric Cancer, run by University of Witten/Herdecke at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Constance Boyde, cand. Dr. (0049-2302/9267738, constance.boyde@uni-wh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Parent-Child Interaction (APCI) (time frame: Baseline, Change in 10th hour of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534282, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.