Dance Movement Therapy for Radio-oncological Patients

NCT07001033 | Completed

• 1 other identifier: FAU 24-505-B
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Patients and Physical Activity

Keywords

Dance Movement Therapy (DMT); Breast or Prostate cancer and complementary therapy; immunophenotyping; muscle strength and bioelectrical impedance analysis (BIA); EQ-5D-5L

Outcome Measures

Primary Outcomes (1)

• Primary objective

  Questionnaire-based (EQ-5D-5L) measurement of well-being containts two main parts: 1) descriptive part in 5 dimentions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimensions have 5 possible answers: no problems, slight problems, moderate problems, severe problems, extreme problems. This is used to define so-called EQ-5D Health States. A total of 3125 different health states can be recorded. Depending on the level, each dimension is assigned a number, resulting in a 5-digit number combination. This 5-digit number can be converted into a score (EQ-5D-5L Index) using a special algorithm that is not publicly available and represents the patient's state of health. An index value of 1 represents the best possible state of health, whil 2) Visual Analogue Scale (VAS) a vertical scale on which the participants indicate their self-related state of health, with 0 representing "The worst health you can imagine" and 100 "The best health you can imagine".

  in the week 1 (baseline) in the week 3, in the week 5 (end of study)

Secondary Outcomes (7)

• Assessment of muscle strength using the Jamar hand dynamometer

  weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)

• Assessment of Body Mass Index

  weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)

• Assessment of percentage proportion in the patient´s body of fat and skeletal muscle using Bioelectrical Impedance Analysis (BIA)

  weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)

• Assessment of Resting Metabolism (RM) using Bioelectrical Impedance Analysis (BIA)

  weekly: in the week 1 (baseline) 2, 3, 4 and 5 (end of study)

• Assessment of laboratory parameters and comparison with standard values

  in the week 1 (baseline) in the week 3, in the week 5 (end of study)

Study Arms (1)

DMT arm

OTHER

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.

Behavioral: Dance Movement Therapy (DMT)

Interventions

Dance Movement Therapy (DMT) 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.

DMT arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Motor Activity; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: June 3, 2025
• Study Start: February 22, 2025
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)