Quality of Life Improvement During Chemotherapy (QoLMa)

Quality of Life Improvement of Breast Cancer Patients During Chemotherapy With Structured Psychological Interventions

This study is a randomized controlled trial, taking place at the University Hospital Basel (CH). It aims at the alleviation of breast cancer patients' life quality during chemotherapy.

The intervention group will participate in 10 sessions of structured hypnotherapy during the course of chemotherapy in addition to the standard of care. The control group will have access to the standard of care without any additional treatment. The main goal of the study is to investigate whether quality of life is higher among patients in the intervention group. Additionally, it will be analyzed if the interventions have a positive effect on chemotherapy side effects, symptoms of anxiety and depression and the immune system. Finally, the relative dose intensity (RDI) as well as treatment schedule adherence will be assessed.

There are no risks to be expected from the intervention itself. In the case of positive findings, the standard of psycho-oncological care can be updated by integrating structured hypnotherapeutic interventions into the treatment of patients with breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy Effect; Breast Cancer Female
• Intervention / Treatment: Behavioral: Structured Hypnotherapy

Detailed Description

Background:

Breast cancer patients who undergo chemotherapy are likely to experience lower life quality, side effects like nausea and vomiting and symptoms of anxiety or depression. At the same time their immune system is down regulated by a stress reaction following cancer diagnosis and also by the chemotherapy itself. Decrease of several immune factors is associated with lower survival expectancy.

Hypnotherapy uses methods like relaxation, symptom-control techniques, imagination and working with inner resources. They can be used to bring positive change for patients both mentally as well as physically. Self-hypnosis techniques are used to bring back a feeling of self-efficacy which is impaired in most cancer patients who report to lose control over their body.

Emerging evidence shows the effectiveness of hypnotherapy in reducing side-effects of medical treatments and improve mental health and quality of life of cancer patients. It was shown that hypnotherapy has a positive effect on several immune factors. But up to now it is not clear if there is also a positive effect on the immune system during chemotherapy.

During Chemotherapy it is important that patients adhere as much as possible to the treatment schedule and to the optimal dosage. Due to chemotherapy side-effects or other reasons it happens regularly that treatment needs be delayed or dosage reduced which in turn lowers the efficiency of the chemotherapy.

Objectives:

This study is designed to evaluate if hypnotherapy has a positive effect on quality of life, side-effects of chemotherapy, symptoms of anxiety and depression, the immune system and the relative dose intensity (RDI) of female breast cancer patients during the course of chemotherapy.

Study Flow:

After patients have been diagnosed with primary breast cancer and were assigned to either adjuvant or neo-adjuvant chemotherapy they are asked if they want to participate in the study and are given all the necessary information and consent form. If they agree, they will be randomly assigned to either the control group or the intervention group following a computer generated randomization list. Before the first session of hypnotherapy they will be given the first questionnaires (T0). Those assigned to the intervention group will be contacted by a therapist to fix a date for the first session, if possible before the first chemotherapy cycle or shortly after the first cycle, when the side effects are not yet present. During 4,5 months, patients will receive 6 cycles of chemotherapy and 10 session of hypnotherapy. They will have access to the standard of psycho-oncological care during the study. The control group will not receive any Hypnotherapy but also has access to the standard of psycho-oncological care.

Measurement Points:

T0 (Baseline) = After diagnosis and before the first chemotherapy cycle

T1 = First cycle of chemotherapy

T2 = Second cycle

T3 = Third cycle

T4 = Fourth cycle

T5 = Fifth cycle

T6 = Sixth cycle

The duration of one cycle will be approx. 3 weeks, depending on the individual chemotherapy regimen.This means that the total time for the chemotherapy of one patient will last around 18 weeks.

There are no risks to be expected from the intervention itself. In the case of positive findings, the standard of psycho-oncological care can be updated by integrating structured hypnotherapeutic interventions into the treatment of patients with breast cancer.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Schwegler, Dr.; Phone Number: +49 (0)170 472 47 47; Email: christian@praxisschwegler.ch
• Study Contact Backup: Name: Isabel Ge, Dr.; Phone Number: +41 (0)61 328 58 85; Email: isabellxiang.ge@usb.ch

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • Recruiting
      • University Hospital Basel
      • Contact: Christian Schwegler, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Minimum Age 18 years
• Female
• Primary breast cancer
• Receiving neo-adjuvant or adjuvant chemotherapy

Exclusion Criteria:

• Verbal or cognitive deficits that are not compatible with outpatient psychotherapy
• Not consenting patients and vulnerable persons
• Psychological disorders that prevent patients from participating in the study (e.g. psychotic disorder)
• acute suicidality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; The control group will receive the standard of psycho-oncological care.
Experimental: Standard of Care + Structured Hypnotherapy; The intervention group will receive the standard of psycho-oncological care plus 10 hypnotherapeutic sessions every two weeks.	Behavioral: Structured Hypnotherapy; The Intervention includes 10 structured hypnotherapy sessions lasting 45 to 60 minutes. During hypnosis, patients reach a trance-like state comparable to a deep relaxation. The therapist guides the patient verbally and also communicates with the patient. Patients will be supported to use their own imagination without suggesting any imagery. By repeatedly asking what the patient is perceiving, and by verbally repeating what the patient is saying, the therapist can help the patient to go deeper into trance. In these trance states the patient learns to reduce negative side effects of the chemotherapy and increase the quality of life by activating both physical and mental resources using imagination and focusing on positive memories and feelings.; Other Names: Structured Psychological Intervention; Hypnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Summary Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	The outcome measure will be the average of all 6 time points on the EORTC QLQ-C30 summary score. The summary score ranges from 0 to 100 with higher scores representing a better quality of life. In the statistical analysis this average summary score will be corrected for values of the summary score at T0.	6 times within 18 weeks + baseline at day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	Summary score of the EORTC QLQ-C30 on all 7 time points including baseline. The summary score ranges from 0 to 100 with higher scores representing a better quality of life. In the statistical analysis the summary score will be compared between all time points to see the development of life quality throughout the chemotherapy.	7 times within 18 weeks
Side Effects of Chemotherapy	Side effects of chemotherapy will also be captured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). It contains three symptom scales (fatigue, pain, nausea and vomiting) and single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation, diarrhea and financial problems). All symptom scales range from 1-4 with higher values representing higher levels of symptoms.	7 times within 18 weeks
Hamilton Anxiety and Depression Scale - German Version (HADS-D)	The HADS-D has two sub-scales for anxiety and depression. Each sub-scale ranges from 0 to 21 with higher values representing more severe symptoms of depression and anxiety respectively. <= 7 unproblematic 8 - 10 threshold >= 11 problematic	7 times within 18 weeks
Immune Factors	Count of cells per micro-liter (μL) of: Natural killer cells (NK); CD4 (also called T-helper cells); CD8 (marker for cytotoxic T-cells)	3 times within 18 weeks
Interleukin-6	Counts of picogram per milliliter (pg/mL) of IL-6 (interleukin-6)	3 times within 18 weeks
Tumor Marker CA 15-3	Counts of international units per milliliter (IU/mL) of tumor marker CA 15-3	3 times within 18 weeks
Relative Dose Intensity (RDI)	RDI = % dose x (planned days / used days). Reference values: >85% effective treatment, <=85% ineffective and significantly decreased survival chances.	18 weeks
Schedule Modification: Delayed Cycles	Delayed cycles. Reference value >=2. The less cycles are delayed, the more efficient is the chemotherapy. If two or more cycles have been delayed, we consider it a significant decrease in schedule adherence.	18 weeks
Schedule modification: Delayed Days	Delayed days. Reference value >=14. The less days are delayed, the more efficient is the chemotherapy. If 14 or more days have been delayed, we consider it a significant decrease in schedule adherence.	18 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Analysis of the Correlation between Quality of Life, Anxiety, Depression and Immunfaktors and Tumor Marker	Individual correlations between quality of life, side effects of chemotherapy, anxiety and depression (specified as outcome measures 2 - 4) and each of the immune factors and tumor marker (outcome measures 5 - 7). Due to lack of pre-existing evidence, we make no predictions about direction and magnitude of the effects.	18 weeks

Collaborators and Investigators

• Sponsor: Christian Schwegler
• Investigators: Principal Investigator: Christian Schwegler, Dr., University Hospital, Basel, Switzerland; Study Director: Isabel Ge, Dr., University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2021
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Quality of life; Breast cancer; Hypnosis; Immunity; Hypnotherapy; Chemotherapy; Dose-response effect
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: QoLMa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual request will be evaluated and shared if appropriate.
• IPD Sharing Time Frame: After publication of first results. Data will be available for 10 years.
• IPD Sharing Access Criteria: Will be evaluated upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No