Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy

NCT03740984 | Terminated

• 1 other identifier: Gyn F-Chem
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 3

Brief Summary

Chemotherapies often induce side effects. This study examines whether hypnosis, music therapy versus standard therapy influence these side effects.

Conditions

Breast Neoplasm; Ovary Cancer

Keywords

Chemotherapy; Side effects of chemotherapy

Outcome Measures

Primary Outcomes (5)

• ZSDS = Zung Self-rating Depression Scale

  Change of questionnaire scores

  Every three weeks during chemotherapy and one year after last chemotherapy

• Quality of life questionnaire - Core30

  Change of questionnaire scores

  Every three weeks during chemotherapy and one year after last chemotherapy

• Patient diary, number of emetic episodes, the intensity of Nausea and QoL evaluation (functional living index-emesis questionnaire)

  Change of questionnaire scores

  Day 1-5 after chemotherapie and before next chemotherapy

• Fatigue assessment questionnaire (FAQ)

  Change of questionnaire scores

  Every three weeks during chemotherapy and one year after last chemotherapy

• Screening Scale for Taste Alteration (TA)

  Change of questionnaire scores

  Every three weeks during chemotherapy and one year after last chemotherapy

Secondary Outcomes (1)

• Change of heart rate

  change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy

Study Arms (3)

Hypnosis / Hypnotherapy

EXPERIMENTAL

Hypnosis intervention has been created by a certified hypnosis therapist (Prof. Reinhard) has been audio-recorded. The hypnosis intervention is based on the patient's happy place as well as many other interventions which all focus on support and wellbeing (total recording time ca. 4 ½ hours). All patients are advice to start with the beginning, however during the course of chemotherapy they are allowed to skip mp3 files, if they prefer to listen to a new intervention.

Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.

Music therapy

EXPERIMENTAL

For the music therapy the following music recordings have been used. All patients were allowed to skip tracks if they did not like to listen to that particular track. Purple Waves - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Black Garden View - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Sunset Destination - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Crystal Tree - Berlin Symphonic Film orchestra / Christopher Franke - Pacific Coast Highway Best nature sounds / Ocean Volume 2 - Best Relaxation Music - Deep Sleep Top 10 Serse: Aria "Ombra mai Fu" - Andreas Scholl, Akademie für Alte music Berlin - Händel Johann Sebastian Bach: Jesus Bleibet Meine Freude (Studio) - Eduard Stan - Piano Recital Mozart: Concerto pour violon no 4 en re majeur, KV (Köchel listing) 218 - Christian Ferras; Pietro Argento; Orchestra Scarlatti di Nap - La fete a Stradivarius ... etc.

Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.

Standard therapy

PLACEBO COMPARATOR

In this standard therapy the patient listens to a short explanation that they were randomized into the control arm and that they are allowed to listen to silence (tracks with no music or intervention).

Other: Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.

Interventions

Interventions are self controlled by the patient via a mp3 player and noise reduction headphones. OTHER

During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.

Hypnosis / Hypnotherapy; Music therapy; Standard therapy

Eligibility Criteria

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

You may qualify if:

• no previous chemotherapy
• compliance of the patient to fill out questionnaires
• informed consent and signed forms
• histologic secured breast cancer or ovary cancer (residual tumor after surgery equal or less than 0,5 cm)
• One of following chemotherapy regime:
• x Epirubicin / Cyclophosphamid, 12x paclitaxel oder 6x Carboplatin / Docetaxel / Perjeta/ Herceptin oder 6x Doxorubicin, docetaxel, Cyclophosphamid oder 6 x Carboplatin / paclitaxel + / - Avastin oder 4x Epirubicin / Cyclophosphamid -\> 12x paclitaxel /herceptin/ perjeta oder 4x Epirubicin / Cyclophosphamid q21-\>12xcarboplatin, paclitaxel 4 Epirubicin / Cyclophosphamid q14-\> 12 carboplatin, paclitaxel

You may not qualify if:

• does not understand the German language
• psychosis
• not able to sign consent form

Sponsors & Collaborators

• Dr. Horst Schmidt Klinik GmbH: lead
• Deutsche Gesellschaft für hypnose und hypnotherapie E.V.: collaborator

Study Sites (3)

Klinik für Gynäkologie und gynäkologischen Onkologie

Wiesbaden, Hesse, 65199, Germany

Location

Helios Berlin Buch

Berlin, 13125, Germany

Location

Helios Kliniken Schwerin GmbH

Schwerin, 19049, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single blinded. The participant knows which group intervention is being used (music, hypnosis or standard care). This is being told while listening to the Intervention. All care Providers only know which "colour" mp3 player is being used (white, orange or black).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective randomised Trial: Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: November 14, 2018
• Study Start: February 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)