C80
Conditions
Interventions
Group 1: Participants perform a home-based, two-part singing intervention on 28 consecutive days, each evening for approximately 15 minutes. First, they complete about 5 minutes of guided breathing an
Sponsors
Universitätsklinikum Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Confirmed oncological disease - Outpatient treatment at the day therapy center of the Mannheim Cancer Center - Capacity to give informed consent - Written informed consent - Sufficient German language skills to understand study information - Willingness and practical ability to complete the 28-day home-based singing intervention and all assessments
Exclusion criteria
Exclusion criteria: - Severe hearing impairment - Hypocortisolism or hypercortisolism - Current use of medications that markedly affect cortisol levels - No or insufficient scalp hair (hair length < 1.5 cm in the occipital region) - Anticipated substantial chemotherapy-induced hair loss due to a recently started regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are the changes in hair cortisol concentration and patient-reported outcomes from before to after the 28-day singing intervention. These include hair cortisol as a surrogate marker of long-term stress exposure, pain and fatigue assessed by numeric rating scales, health-related quality of life measured with the EORTC QLQ-C30, fear of cancer progression with the PA-F, spiritual well-being with the FACIT-Sp-12, and sleep quality with the Pittsburgh Sleep Quality Index. All parameters are assessed at two time points: before the start of the intervention (baseline, T1) and immediately after completion of the 28-day intervention period (T2). Hair samples (approximately 1.5 cm from the posterior scalp) are analyzed by LC-MS in an external laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints comprise exploratory subgroup and sensitivity analyses of the primary outcomes and the changes in additional hair steroid hormones, in particular DHEA, testosterone, progesterone, and cortisone. Change scores from T1 to T2 are analyzed in subgroups defined by adherence (e.g. high vs. low compliance according to the number of intervention days), sex, tumor entity, treatment intent, and current chemotherapy. Subgroup allocation is based on study diaries and clinical baseline data, and analyses use non-parametric tests such as the Wilcoxon signed-rank test and the Mann-Whitney U test. | — |
Countries
Germany
Contacts
Public ContactRalf-Dieter Hofheinz
Universitätsklinikum Mannheim
Outcome results
None listed