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JOURNAL ONKOLOGIE – STUDIE
QoLMa

Quality of Life Improvement During Chemotherapy

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NCT-Nummer:
NCT04694885

Studienbeginn:
Januar 2021

Letztes Update:
05.01.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Christian Schwegler

Collaborator:
-

Studienleiter

Homen Begovic, Dr.
Study Director
University Hospital, Basel, Switzerland
Christian Schwegler, Dr.
Principal Investigator
University Hospital, Basel, Switzerland

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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.



Secondary outcome:

1. 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):
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.

2. Side Effects of Chemotherapy (Time Frame - 7 times within 18 weeks):
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.

3. Hamilton Anxiety and Depression Scale - German Version (HADS-D) (Time Frame - 7 times within 18 weeks):
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

4. Immune Factors (Time Frame - 3 times within 18 weeks):
Count of cells per micro-liter (μL) of: Natural killer cells (NK) CD4 (also called T-helper cells) CD8 (marker for cytotoxic T-cells)

5. Interleukin-6 (Time Frame - 3 times within 18 weeks):
Counts of picogram per milliliter (pg/mL) of IL-6 (interleukin-6)

6. Tumor Marker CA 15-3 (Time Frame - 3 times within 18 weeks):
Counts of international units per milliliter (IU/mL) of tumor marker CA 15-3

7. Relative Dose Intensity (RDI) (Time Frame - 18 weeks):
RDI = % dose x (planned days / used days). Reference values: >85% effective treatment, <=85% ineffective and significantly decreased survival chances.

8. Schedule Modification: Delayed Cycles (Time Frame - 18 weeks):
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.

9. Schedule modification: Delayed Days (Time Frame - 18 weeks):
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.

Studien-Arme

  • 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.

Geprüfte Regime

  • Structured Hypnotherapy (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.

Quelle: ClinicalTrials.gov


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