Breast Cancer FemaleQoLMaNCT04694885
Quality of Life Improvement During Chemotherapy
A study testing Structured Hypnotherapy in people with Breast Cancer Female and Chemotherapy Effect, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Chemotherapy Effect
- What is being tested?
- Structured Hypnotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Jul 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum Age 18 years
- Female
- Primary breast cancer
- Receiving neo-adjuvant or adjuvant chemotherapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4056
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Female, Chemotherapy Effect
- Being tested
- Structured Hypnotherapy
- Keywords
- Breast cancer, Chemotherapy, Hypnotherapy, Hypnosis, Quality of life, Anxiety, Depression, Immunity, Dose-response effect
- Medical subject headings
- Breast Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured HypnotherapyBehavioural
Also called Structured Psychological Intervention, Hypnosis
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | The control group will receive the standard of psycho-oncological care. |
| Standard of Care + Structured Hypnotherapy | Experimental | The intervention group will receive the standard of psycho-oncological care plus 10 hypnotherapeutic sessions every two weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 times within 18 weeks + baseline at day 1
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 3 times within 18 weeks
Interleukin-6
Counts of picogram per milliliter (pg/mL) of IL-6 (interleukin-6)
Measured: 3 times within 18 weeks
Tumor Marker CA 15-3
Counts of international units per milliliter (IU/mL) of tumor marker CA 15-3
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start31 Jul 2021
- Primary completion30 Apr 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a monocentric randomized controlled trial with two parallel arms. All participants will be recruited in the University Hospital Basel (CH). They must be adult, female, diagnosed with first time breast cancer and undergoing adjuvant or neo-adjuvant chemotherapy. During chemotherapy, the control group as well as the intervention group will be offered the standard of psycho-oncological care. This means they can chose how much psychological support they want to use. Additionally, participants in the intervention group participate in 10 structured sessions of hypnotherapy aimed to alleviate quality of life. These therapeutic sessions will take place approximately every two to three weeks.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabell Ge, Dr., Principal investigator, University Hospital BaseChristian Schwegler, Dr., Study chair, Milton H. Erickson Gesellschaft für Klinische HypnoseChristian Kurzeder, Prof. Dr., Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694885
- Sponsor's protocol ID
- QoLMa
- Acronym
- QoLMa
- Status last verified
- May 2026
- First submitted
- 18 Dec 2020
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual request will be evaluated and shared if appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Improvement of Breast Cancer Patients During Chemotherapy With Structured Psychological Interventions
- ClinicalTrials.gov ID
- NCT04694885
- Acronym / sponsor ID
- QoLMa / QoLMa
- Conditions
- Breast Cancer Female, Chemotherapy Effect
- Keywords
- Breast cancer, Chemotherapy, Hypnotherapy, Hypnosis, Quality of life, Anxiety, Depression, Immunity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a monocentric randomized controlled trial with two parallel arms. All participants will be recruited in the University Hospital Basel (CH). They must be adult, female, diagnosed with first time breast cancer and undergoing adjuvant or neo-adjuvant chemotherapy. During chemotherapy, the control group as well as the intervention group will be offered the standard of psycho-oncological care. This means they can chose how much psychological support they want to use. Additionally, participants in the intervention group participate in 10 structured sessions of hypnotherapy aimed to alleviate quality of life. These therapeutic sessions will take place approximately every two to three weeks.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –The control group will receive the standard of psycho-oncological care. |
| Standard of Care + Structured Hypnotherapy | Experimental | –The intervention group will receive the standard of psycho-oncological care plus 10 hypnotherapeutic sessions every two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum Age 18 years
- Female
- Primary breast cancer
- Receiving neo-adjuvant or adjuvant chemotherapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured HypnotherapyAlso: Structured Psychological Intervention, HypnosisThe 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. | Behavioural | – |
Primary outcome
Average Summary Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 6 times within 18 weeks + baseline at day 1
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.
9 secondary outcomes
Summary Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 7 times within 18 weeks
Side Effects of Chemotherapy
Time frame: 7 times within 18 weeks
Hamilton Anxiety and Depression Scale - German Version (HADS-D)
Time frame: 7 times within 18 weeks
Immune Factors
Time frame: 3 times within 18 weeks
Interleukin-6
Time frame: 3 times within 18 weeks
Tumor Marker CA 15-3
Time frame: 3 times within 18 weeks
Relative Dose Intensity (RDI)
Time frame: 18 weeks
Schedule Modification: Delayed Cycles
Time frame: 18 weeks
Schedule modification: Delayed Days
Time frame: 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual request will be evaluated and shared if appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabell Ge, Dr. principal investigator
University Hospital Base
Christian Schwegler, Dr. study chair
Milton H. Erickson Gesellschaft für Klinische Hypnose
Christian Kurzeder, Prof. Dr. study director
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Hypnotherapy in people with Breast Cancer Female and Chemotherapy Effect, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Summary Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (time frame: 6 times within 18 weeks + baseline at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.