Dance Movement Therapy for Radio-oncological Patients

NCT ID: NCT07001033

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-22
• Study Completion Date: 2025-04-20

Brief Summary

Dance-RT-01 investigates the feasibility and effects of Integrative, resource-oriented short term Dance Movement Therapy (DMT) in radio-oncological patients shortly after radiotherapy (RT). The study assesses clinical outcomes, including reduction of fatigue, improvement of quality of life (QoL), functional capacity and body composition. Immunophenotyping and laboratory blood analyses ensure objectively measurable results. Eligible patients participate in short term DMT, that is combined with psychotherapeutic elements. The trial aims to evaluate DMT's potential as a complementary therapy method in cancer care to support recovery and provide a comprehensive understanding of the therapy's effects.

Detailed Description

The study is designed as investigator-initiated, prospective, non-randomized feasibility trial and includes radio-oncological patients (ECOG 0-2) who recently completed RT. The primary endpoint is to decide upon the feasibility, as well as identification of specific immunological changes in peripheral blood that contribute to the success of DMT (longitudinal analysis). The benefit for patients is seen in a resource activation after RT and improvement of well-being. Secondary endpoints include functional capacity, measured by maximum grip strength, body composition, assessed through bioelectrical impedance analysis (BIA), assessment of QoL, pain and reduction of fatigue using validated and standardized questionnaires for patient reported outcomes with comparable results. In addition, immunophenotyping is performed. Further laboratory analyses include inflammatory markers, hormone levels, and nutritional biomarkers. These data are analyzed to evaluate correlation of immunological changes with clinical outcomes.

Participants complete five weekly DMT sessions (90 minutes each). Each session integrates structured movement exercises, music, and psychotherapeutic elements, that can be tailored depending on each individual patient. The therapy is carried out by a certified therapeutic dance instructor with expertise in radio-oncology.

Conditions

Cancer Patients and Physical Activity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DMT arm

All patients receive a dance movement therapy intervention once a week for 90 minutes over a period of five weeks, which is combined with psychotherapeutic content. The therapy is carried out by one specially trained DMT therapist with experience in radiooncology.

The structure of the sessions is designed in such a way that there is a 15-minute starting phase with a mindfulness exercise and opening flash, followed by a 50-minute active phase in which special topic are carried out:

Therapy sessions and topics:

1. Introduction. Get to know. Encounter.

2. Body awareness and dealing with one's own limits.

3. Social relationships. Proud. Becoming aware of your own resources.

4. "Cage of emotions". Release.

5. Conclusion. Reflection and transfer to everyday life. Farewell.

Group Type: OTHER

Dance Movement Therapy (DMT)

Intervention Type: BEHAVIORAL

All participants will be invited to five group meetings at weekly intervals. Each of these therapy sessions will take place with a specific theme. In weeks 1 and 5, data important for the study will be collected once before the short-term DMT and once again at the end of the study. This includes different assessments, laboratory blood tests as well as immunophenotyping. Additionally, patients are requested to complete a questionnaire that addresses QoL. Specific examinations, such as testing the maximal handgrip strength, a BIA and recording Eastern Cooperative Oncology Group (ECOG) performance status are implemented in each of the five meetings.

Interventions

Dance Movement Therapy (DMT)

All participants will be invited to five group meetings at weekly intervals. Each of these therapy sessions will take place with a specific theme. In weeks 1 and 5, data important for the study will be collected once before the short-term DMT and once again at the end of the study. This includes different assessments, laboratory blood tests as well as immunophenotyping. Additionally, patients are requested to complete a questionnaire that addresses QoL. Specific examinations, such as testing the maximal handgrip strength, a BIA and recording Eastern Cooperative Oncology Group (ECOG) performance status are implemented in each of the five meetings.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male and female oncological patients
• Age at least 18 years. No upper age limit
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Written informed consent for participation in the study
• Prior RT received shortly before study inclusion (therapy completed)
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including

Exclusion Criteria

• Inability to speak and understand German
• Serious concurrent neurologic or psychiatric disorders: dementia, uncontrolled seizures, psychosis, schizophrenia, neurosis, autism that would interfere with cooperation with the requirements of the trial
• Familial, sociological, or geographical condition that would preclude study compliance (these conditions should be discussed with the patient before registration in the study)
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the study team
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• Is pregnant or breastfeeding, or expecting to conceive

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg

Erlangen, Bavaria, Germany

Countries

Germany

Other Identifiers

FAU 24-505-B

Identifier Type: -

Identifier Source: org_study_id