Clinical trial NCT04694885: Quality of Life Improvement During Chemotherapy
Official title: Quality of Life Improvement of Breast Cancer Patients During Chemotherapy With Structured Psychological Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Chemotherapy Effect
Keywords: Breast cancer
Chemotherapy
Hypnotherapy
Hypnosis
Quality of life
Anxiety
Depression
Immunity
Dose-response effect
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Summary Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: 6 times within 18 weeks + baseline at day 1
Secondary outcomes:
measure: Summary Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: 7 times within 18 weeks
measure: Side Effects of Chemotherapy
timeFrame: 7 times within 18 weeks
measure: Hamilton Anxiety and Depression Scale - German Version (HADS-D)
timeFrame: 7 times within 18 weeks
measure: Immune Factors
timeFrame: 3 times within 18 weeks
measure: Interleukin-6
timeFrame: 3 times within 18 weeks
measure: Tumor Marker CA 15-3
timeFrame: 3 times within 18 weeks
measure: Relative Dose Intensity (RDI)
timeFrame: 18 weeks
measure: Schedule Modification: Delayed Cycles
timeFrame: 18 weeks
measure: Schedule modification: Delayed Days
timeFrame: 18 weeks
Other outcomes:
measure: Exploratory Analysis of the Correlation between Quality of Life, Anxiety, Depression and Immunfaktors and Tumor Marker
timeFrame: 18 weeks
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Isabel Ge, Dr.
role: STUDY_DIRECTOR
affiliation: University Hospital, Basel, Switzerland
name: Christian Schwegler, Dr.
role: PRINCIPAL_INVESTIGATOR
References: