Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer - Female
  • Chemotherapy Effect
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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...

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.

Tracking Information

NCT #
NCT04694885
Collaborators
Not Provided
Investigators
Study Director: Homen Begovic, Dr. University Hospital, Basel, Switzerland Principal Investigator: Christian Schwegler, Dr. University Hospital, Basel, Switzerland