Mind-body Online Therapy in Gynecological Oncology

NCT05313724 | Unknown DMC

• 1 other identifier: 2022-00174
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

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; Psychotherapy

Outcome Measures

Primary Outcomes (11)

• Anxiety and depression

  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)

  German version of the questionnaire "Hamilton Depression Scale" (HAM-D17; Hamilton, 1960; Hamilton, 1986)

  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)

  Changes between week 0, 8, 16

• General distress

  German version of the questionnaire "Distress Thermometer" (BTH; Mehnert et al., 2006)

  Week 0, Week 8, Week 16

• Psychological stress

  German version of the questionnaire "Symptom Checklist" (SCL-K11; Franke, 2001; Franke, 2002)

  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)

  Changes between week 0, 8, 16

• Insomnia (Severity)

  German version of the questionnaire "Insomnia Severity Index" (ISI; Morin, 1993)

  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)

  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)

  Changes between week 0, 8, 16

• SpO2 [%]

  Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)

  Changes between week 0, 8, 16

• Peripheral arterial tone (PAT) [mmHG]

  Sleep diagnostic system "WatchPAT" (Neumedpro, Neuwirth Medical Products, 2021)

  Changes between week 0, 8, 16

Secondary Outcomes (3)

• Feasibility of the intervention (Patient-therapist relationship)

  Changes between week 8, 16

• Feasibility of the intervention (Usability)

  Changes between week 8, 16

• Feasibility of the intervention (Patient satisfaction)

  Changes between week 8, 16

Study Arms (2)

Mind-Body Online Therapy

EXPERIMENTAL

Other: Mind-Body Online Therapy

TAU (treatment as usual)

NO INTERVENTION

Interventions

Mind-Body Online Therapy 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.

Mind-Body Online Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Katja Haemmerli Keller: lead
• University of Bern: collaborator

Study Sites (1)

Clinic for Psychosomatic Medicine and Consultation-Liaison Psychiatry

Sankt Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 6, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)