Gynecologic CancerNCT05313724
Mind-body Online Therapy in Gynecological Oncology
A study testing Mind-Body Online Therapy in people with Gynecologic Cancer, run by Katja Haemmerli Keller at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Mind-Body Online Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2022to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry
Sankt Gallen, 9007
Katja H H Keller, +41714941727, katja.haemmerlikeller@kssg.ch
About this study
Official title: 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.
- Conditions
- Gynecologic Cancer
- Being tested
- Mind-Body Online Therapy
- Keywords
- Mind, Body, MBM, Mind Body Medicin, Online Therapy, Online-Therapie, Internettherapie, Internet Therapy, Selbsthilfeintervention, Onkologie, Oncology, Krebs, Cancer, Gynäkologie, Gynecology, Frauenklinik, Frauenheilkunde, Psychosomatik, Psychosomatics, Psychotherapie
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Online TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mind-Body Online Therapy | Experimental | Not described Receives: Other: Mind-Body Online Therapy |
| TAU (treatment as usual) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression
German version of the questionnaire "Hospital Anxiety and Depression Scale" (HADS; (Herrmann et al., 1995; Herrmann-Lingen et al., 2011)
Measured: Changes between week 0, 8, 16
Depression (external assessment)
German version of the questionnaire "Hamilton Depression Scale" (HAM-D17; Hamilton, 1960; Hamilton, 1986)
Measured: Changes between week 0, 8, 16
Somatization
German version of the questionnaire "Patient Health Questionnaire" (PHQ-9; Gräfe et al., 2004; Kroenke et al., 2010)
Measured: Changes between week 0, 8, 16
General distress
German version of the questionnaire "Distress Thermometer" (BTH; Mehnert et al., 2006)
Measured: Week 0, Week 8, Week 16
Psychological stress
German version of the questionnaire "Symptom Checklist" (SCL-K11; Franke, 2001; Franke, 2002)
Measured: Changes between week 0, 8, 16
Impairment from cancer therapy
German version of the questionnaire "Functional Assessment of Cancer Therapy" (FACT-G; Cella \& Bonomi, 1996; Cella et al., 1993)
Measured: Changes between week 0, 8, 16
Insomnia (Severity)
German version of the questionnaire "Insomnia Severity Index" (ISI; Morin, 1993)
Measured: Changes between week 0, 8, 16
Sleep quality
German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 1989; Carpenter \& Andrykowski, 1998)
Measured: Changes between week 0, 8, 16
Health-related quality of life
German version of the questionnaire "Short Form 12" (SF-12; Morfeld et al., 2012)
Measured: Changes between week 0, 8, 16
SpO2 [%]
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)
Measured: Changes between week 0, 8, 16
Peripheral arterial tone (PAT) [mmHG]
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)
Measured: Changes between week 0, 8, 16
Secondary outcomes (3)
Feasibility of the intervention (Patient-therapist relationship)
German version of the questionnaire "Working Alliance Inventory - Short Revised" (WAI-SR; Wilmers et al., 2008)
Measured: Changes between week 8, 16
Feasibility of the intervention (Usability)
German version of the questionnaire "System Usability Scale" (SUS; Brooke, 1996)
Measured: Changes between week 8, 16
Feasibility of the intervention (Patient satisfaction)
German questionnaire "Patient Satisfaction" (ZUF-8; Schmidt \& Wittmann, 2002)
Measured: Changes between week 8, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katja Haemmerli Keller
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor-investigator, Katja Haemmerli Keller, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313724
- Sponsor's protocol ID
- 2022-00174
- Status last verified
- Sep 2023
- First submitted
- 11 Mar 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-body Online Therapy in a Somatic Setting - a Randomized-controlled, Two-arm, Monocentric Study in Gynecological Oncology
- ClinicalTrials.gov ID
- NCT05313724
- Acronym / sponsor ID
- 2022-00174
- Conditions
- Gynecologic Cancer
- Keywords
- Mind, Body, MBM, Mind Body Medicin, Online Therapy, Online-Therapie, Internettherapie, Internet Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Katja Haemmerli KellerUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Online Therapy | Experimental | Other: Mind-Body Online Therapy |
| TAU (treatment as usual) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-Body Online TherapyThere 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. | Other | Mind-Body Online Therapy |
Primary outcome
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)
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)
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)
General distress
Time frame: Week 0, Week 8, Week 16
German version of the questionnaire "Distress Thermometer" (BTH; Mehnert et al., 2006)
Psychological stress
Time frame: Changes between week 0, 8, 16
German version of the questionnaire "Symptom Checklist" (SCL-K11; Franke, 2001; Franke, 2002)
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)
Insomnia (Severity)
Time frame: Changes between week 0, 8, 16
German version of the questionnaire "Insomnia Severity Index" (ISI; Morin, 1993)
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)
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)
SpO2 [%]
Time frame: Changes between week 0, 8, 16
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)
Peripheral arterial tone (PAT) [mmHG]
Time frame: Changes between week 0, 8, 16
Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)
3 secondary outcomes
Feasibility of the intervention (Patient-therapist relationship)
Time frame: Changes between week 8, 16
Feasibility of the intervention (Usability)
Time frame: Changes between week 8, 16
Feasibility of the intervention (Patient satisfaction)
Time frame: Changes between week 8, 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry
Sankt Gallen, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-Body Online Therapy in people with Gynecologic Cancer, run by Katja Haemmerli Keller at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depression (time frame: Changes between week 0, 8, 16). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.