C18
Conditions
Interventions
Group 1: Standard therapy: The participants receive only the standard chemotherapy without any music-based additional intervention.
Group 2: Music therapy: The participants take part in at least 10, a
Sponsors
Medizinische Fakultät Mannheim der Universität Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age: = 18 years - Gender: all genders - Diagnosis: Histologically confirmed, curatively resected colorectal carcinoma (stage II or stage III) - Therapy: Planned adjuvant chemotherapy for at least 3 months
Exclusion criteria
Exclusion criteria: - Age: Under 18 years - Prior treatment: Current use of other music therapy and/or music medicine interventions or use of such interventions within the last three months before study entry, to exclude potential residual effects of previous interventions - Language: Insufficient German language skills so that study information, music interventions, or questionnaires cannot be understood or completed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the net responder rate (NRR) of patient-reported quality of life and patient-reported outcomes (QoL/PRO). The NRR is defined as the percentage of participants who show more improvements than deteriorations in the collected QoL/PRO questionnaires and scales compared to baseline (T0, before the start of adjuvant chemotherapy). To determine the NRR, six established questionnaires/scales on quality of life and other patient-reported endpoints are used before (T0) and after completion (T1) of the 12-week intervention phase. Thus, the NRR represents an objective, clearly measurable criterion that assesses the treatment success of the interventions compared to standard therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of the study are: Therapeutic alliance: Measured using the Working Alliance Inventory (WAI) in Arm B after each therapy session to quantify the quality of the therapeutic relationship as a potential mediating factor. Therapy expectation: Assessed with the Treatment Expectation Questionnaire (TEX-Q) at T0 and the subjective fulfillment of therapy expectations at T1 in the intervention arms. Side effects: recorded using the Negative Effects Questionnaire (NEQ) at T1 in the intervention groups (B and C). Cost-benefit evaluation: Assess using the questionnaire on the use of medical and non-medical health care services in old age (FIMA) at T1. Additional control questions are asked regarding socioeconomy, health status, and psychological influencing factors (e.g., traumatization). In addition, survival and recurrence status will be assessed every six months for up to 2.5 years after last patient in. These secondary endpoints serve to characterize additional influencing factors and mechanisms of the interventions and to examine their significance for the intervention effect, especially in Arm B. For the conceptualization of the music therapy intervention, a participatory approach will be employed. To this end, prior to the start of the study, an online survey will be conducted among music therapists working in oncology to gather experiences and best practice examples. | — |
Countries
Germany
Contacts
Public ContactChristine Gäbel
Medizinische Fakultät Mannheim der Universität Heidelberg
Outcome results
None listed