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Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy (F-Chem)

Primary Purpose

Breast Neoplasm, Ovary Cancer

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.
Sponsored by
Dr. Horst Schmidt Klinik GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasm focused on measuring Chemotherapy, Side effects of chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    4x 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

Exclusion Criteria:

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

Sites / Locations

  • Klinik für Gynäkologie und gynäkologischen Onkologie
  • Helios Berlin Buch
  • Helios Kliniken Schwerin GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Hypnosis / Hypnotherapy

Music therapy

Standard therapy

Arm Description

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.

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.

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).

Outcomes

Primary Outcome Measures

ZSDS = Zung Self-rating Depression Scale
Change of questionnaire scores
Quality of life questionnaire - Core30
Change of questionnaire scores
Patient diary, number of emetic episodes, the intensity of Nausea and QoL evaluation (functional living index-emesis questionnaire)
Change of questionnaire scores
Fatigue assessment questionnaire (FAQ)
Change of questionnaire scores
Screening Scale for Taste Alteration (TA)
Change of questionnaire scores

Secondary Outcome Measures

Change of heart rate
Long term ECG recording before and during chemotherapy

Full Information

First Posted
September 16, 2018
Last Updated
November 9, 2021
Sponsor
Dr. Horst Schmidt Klinik GmbH
Collaborators
Deutsche Gesellschaft für hypnose und hypnotherapie E.V.
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1. Study Identification

Unique Protocol Identification Number
NCT03740984
Brief Title
Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy
Acronym
F-Chem
Official Title
Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy - A Prospective Off-centre Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Funding withdrawn from sponsor.
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Horst Schmidt Klinik GmbH
Collaborators
Deutsche Gesellschaft für hypnose und hypnotherapie E.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chemotherapies often induce side effects. This study examines whether hypnosis, music therapy versus standard therapy influence these side effects.
Detailed Description
Primary study goals are differences in quality of life, nausea and vomiting episodes, fatigue, depression and change of taste.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Ovary Cancer
Keywords
Chemotherapy, Side effects of chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised Trial: Intervention 1 = hypnosis (hypnotherapy), Intervention 2 = Music therapy; Intervention 3 (Standard care)
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis / Hypnotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Music therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard therapy
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.
Intervention Description
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.
Primary Outcome Measure Information:
Title
ZSDS = Zung Self-rating Depression Scale
Description
Change of questionnaire scores
Time Frame
Every three weeks during chemotherapy and one year after last chemotherapy
Title
Quality of life questionnaire - Core30
Description
Change of questionnaire scores
Time Frame
Every three weeks during chemotherapy and one year after last chemotherapy
Title
Patient diary, number of emetic episodes, the intensity of Nausea and QoL evaluation (functional living index-emesis questionnaire)
Description
Change of questionnaire scores
Time Frame
Day 1-5 after chemotherapie and before next chemotherapy
Title
Fatigue assessment questionnaire (FAQ)
Description
Change of questionnaire scores
Time Frame
Every three weeks during chemotherapy and one year after last chemotherapy
Title
Screening Scale for Taste Alteration (TA)
Description
Change of questionnaire scores
Time Frame
Every three weeks during chemotherapy and one year after last chemotherapy
Secondary Outcome Measure Information:
Title
Change of heart rate
Description
Long term ECG recording before and during chemotherapy
Time Frame
change of average heart rate after 5 minutes rest, 5 minutes before chemotherapy and 5 minutes into chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 4x 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 Exclusion Criteria: does not understand the German language psychosis not able to sign consent form
Facility Information:
Facility Name
Klinik für Gynäkologie und gynäkologischen Onkologie
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65199
Country
Germany
Facility Name
Helios Berlin Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Helios Kliniken Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19049
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Music or Hypnotherapy on Cancer Patients During Chemotherapy

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