Mind-body Online Therapy in Gynecological Oncology

September 2, 2023 updated by: Katja Haemmerli Keller

Mind-body Online Therapy in a Somatic Setting - a Randomized-controlled, Two-arm, Monocentric Study in Gynecological Oncology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • St.Gallen, Switzerland, 9007
        • Recruiting
        • Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mind-Body Online Therapy
Other: 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.
No Intervention: TAU (treatment as usual)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety and depression
Time Frame: Changes between week 0, 8, 16
German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; (Herrmann et al., 1995; Herrmann-Lingen et al., 2011)
Changes between week 0, 8, 16
Depression (external assessment)
Time Frame: Changes between week 0, 8, 16
German version of the questionnaire "Hamilton Depression Scale" (HAM-D17; Hamilton, 1960; Hamilton, 1986)
Changes between week 0, 8, 16
Somatization
Time Frame: Changes between week 0, 8, 16
German version of the questionnaire "Patient Health Questionnaire" (PHQ-9; Gräfe et al., 2004; Kroenke et al., 2010)
Changes between week 0, 8, 16
General distress
Time Frame: Week 0, Week 8, Week 16
German version of the questionnaire "Distress Thermometer" (BTH; Mehnert et al., 2006)
Week 0, Week 8, Week 16
Psychological stress
Time Frame: Changes between week 0, 8, 16
German version of the questionnaire "Symptom Checklist" (SCL-K11; Franke, 2001; Franke, 2002)
Changes between week 0, 8, 16
Impairment from cancer therapy
Time Frame: Changes between week 0, 8, 16
German version of the questionnaire "Functional Assessment of Cancer Therapy" (FACT-G; Cella & Bonomi, 1996; Cella et al., 1993)
Changes between week 0, 8, 16
Insomnia (Severity)
Time Frame: Changes between week 0, 8, 16
German version of the questionnaire "Insomnia Severity Index" (ISI; Morin, 1993)
Changes between week 0, 8, 16
Sleep quality
Time Frame: Changes between week 0, 8, 16
German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 1989; Carpenter & Andrykowski, 1998)
Changes between week 0, 8, 16
Health-related quality of life
Time Frame: Changes between week 0, 8, 16
German version of the questionnaire "Short Form 12" (SF-12; Morfeld et al., 2012)
Changes between week 0, 8, 16
SpO2 [%]
Time Frame: Changes between week 0, 8, 16
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)
Changes between week 0, 8, 16
Peripheral arterial tone (PAT) [mmHG]
Time Frame: Changes between week 0, 8, 16
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)
Changes between week 0, 8, 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of the intervention (Patient-therapist relationship)
Time Frame: Changes between week 8, 16
German version of the questionnaire "Working Alliance Inventory - Short Revised" (WAI-SR; Wilmers et al., 2008)
Changes between week 8, 16
Feasibility of the intervention (Usability)
Time Frame: Changes between week 8, 16
German version of the questionnaire "System Usability Scale" (SUS; Brooke, 1996)
Changes between week 8, 16
Feasibility of the intervention (Patient satisfaction)
Time Frame: Changes between week 8, 16
German questionnaire "Patient Satisfaction" (ZUF-8; Schmidt & Wittmann, 2002)
Changes between week 8, 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Katja Haemmerli Keller

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-00174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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