Mind-body Online Therapy in Gynecological Oncology

NCT ID: NCT05313724

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-08-31

Brief Summary

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In this randomized-controlled two-arm monocentric study with three measurement time points, the effectiveness and feasibility of an internet-based, therapist-guided mind-body self-help intervention for gynecological cancer patients with primary diagnoses is examined. Different modules (e.g., relaxation, mindfulness, stress management, disease management, nutrition and exercise behaviors) with a mind-body focus are available for the patients. The goal of the intervention is to improve or maintain the quality of life.

Detailed Description

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Conditions

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Gynecologic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mind-Body Online Therapy

Group Type EXPERIMENTAL

Mind-Body Online Therapy

Intervention Type OTHER

There are 8 different modules (e.g. relaxation, mindfulness, stress management, disease management, nutrition and exercise behavior) with a mind-body focus available for the patients to independently (time, location) work on.

TAU (treatment as usual)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mind-Body Online Therapy

There are 8 different modules (e.g. relaxation, mindfulness, stress management, disease management, nutrition and exercise behavior) with a mind-body focus available for the patients to independently (time, location) work on.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old
* Oncologic disease: first diagnosed; within the first 12 weeks of diagnosis, first-line treatment (either systemic treatment - including chemotherapy, hormonal therapy or targeted therapy - or radiotherapy), Notes: (1) Patients treated for first recurrence of a tumor previously treated with curative intent are also eligible. (2) Psychological distress is taken into account by stratification according to the stress thermometer. In research, this procedure corresponds to the current state-of-the-art. Individual subgroups (e.g. cancer stages) can then be studied post-hoc.
* Sufficient computer skills and internet access
* Availability of an emergency address
* Written informed consent by signing the informed consent form

Exclusion Criteria

* Patient unable to provide written informed consent by signing informed consent form
* Insufficient knowledge of German
* Moderate to severe depressive symptomatology (BDI \> 18; HAM-D17 ≥ 17) during T1 survey
* Suicidality (BDI suicidality item \> 1; HAM-D17 suicidality item ≥ 2) in the context of the T1 survey
* Diagnosis of psychotic, bipolar, or other serious mental or somatic disorder requiring immediate treatment
* Male breast cancer patients
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role collaborator

Katja Haemmerli Keller

OTHER

Sponsor Role lead

Responsible Party

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Katja Haemmerli Keller

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry

Sankt Gallen, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Facility Contacts

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Katja H H Keller

Role: primary

+41714941727

Other Identifiers

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2022-00174

Identifier Type: -

Identifier Source: org_study_id

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