Quality of Life Improvement During Chemotherapy

ConditionsBreast Cancer Female Chemotherapy Effect

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorChristian Schwegler

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Minimum Age 18 years

Female

Primary breast cancer

Receiving neo-adjuvant or adjuvant chemotherapy

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

Structured Hypnotherapy
Behavioral
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.

Treatment groups

62 Participants

are divided into 2 treatment groups

Group A: Standard of CareNo intervention 0 interventions

Group B: Standard of Care + Structured HypnotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

6 times within 18 weeks + baseline at day 1

Secondary outcomes

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.

Time frame

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.

Time frame

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

Time frame

7 times within 18 weeks

Immune Factors

Count of cells per micro-liter (μL) of: 1. Natural killer cells (NK) 2. CD4 (also called T-helper cells) 3. CD8 (marker for cytotoxic T-cells)

Time frame

3 times within 18 weeks

Other outcomes

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.

Time frame

18 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Christian Schwegler

Lead sponsor

University Hospital, Basel, Switzerland

Sponsor institution

Source ClinicalTrials.gov

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