Interaction-focused music therapy with cancer-affected children and their significant others: a randomized controlled feasibility study with subsequent intervention (INMUT)

Abstract

Abstract Background: Paediatric oncology/haematology 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 together offers the possibility to strengthen competences and makes conflicts tangible in a direct way. Besides its complementing of evidence-based biomedical care, there is little research on the feasibility and efficacy of interactive music therapy including the child and its significant other. Methods:We conducted an assessor blind, prospective, multicentric feasibility randomized controlled trial (RCT) with subsequent intervention. Including 52 child-referent dyads, it investigates interaction-focused music therapy with cancer-affected children and their significant others (INMUT-KB; n = 21) compared to music therapy only with the child (MUT-K; n = 21),and a wait-list group (WLG; n = 10). The measurement points include the screening for a cancer diagnosis, psychometric baseline (pre-T1), initial assessment (T1/T2), music therapy sessions (T3-T9), final assessment (T10), final psychometric evaluation (post-T10), and 3-month follow-up(T11). Feasibility and acceptability of the (1) research methodology, (2) intervention, (3) estimation of effect sizes, and (4) service use for health economic evaluation will be assessed using qualitative and quantitative data. The proposed primary outcome includes the parent-child interaction (APCI), and the proposed secondary outcomes refer to the quality of life (KINDL), symptomatology (SCL-9k), social system functioning (EXIS), the psychosocial burden (BAS), resources (WIRF) and the child’s and significant other’s goal attainment (GAS). We plan to investigate the efficacy of INMUT-KB and MUT-K post-intervention (T10) within the RCT design, and at 3-month follow-up (T11). Discussion: This study will provide insights into the feasibility of INMUT, and the final sample needed for a confirmatory RCT. We will reflect on successfully implemented study procedures, and provide recommendations for changes considering the design, procedures, measures, and statistical analyses, if necessary. The discussion will conclude with an evaluation whether a confirmatory RCT is worth the investment of future resources, including the calculated number of child-referent dyads needed based on the efficacy trends derived from this feasibility study. Trial registration: ClinicalTrials.gov: NCT05534282; date of registration: 06/23/2022.