Web-based mindfulness- and skills-based distress reduction for patients with cancer: A multicentre observational healthcare study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017119

Enrollment

103

Registered

2019-09-02

Start date

2019-10-22

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological distress in cancer patients

Interventions

Group 1: All participants will conduct the web-based, psycho-oncological Make It Training (Mindfulness and Skills based distress reduction training in oncology) over a period of four months. Every two

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: minimum age of 18 years, cancer diagnosis, given informed consent, internet access and basic computer skills, good command of the German language

Exclusion criteria

Exclusion criteria: None.

Design outcomes

Primary

Measure	Time frame
The main objective is to find out who starts Make It, who finishes it completely, who finishes it prematurely and who benefits from it. Demographic and medical data are collected before the start of training (T0). Furthermore, data on usability, feasibility and sustainability will be collected. After completion of the training (T1), the system usability scale [SUS] (Brooke, 1996), Fragebogen zur Messung der Patientenzufriedenheit [ZUF-8] (Schmidt & Nübling, 2002) and self-generated items will be queried. Furthermore, reasons for drop-out are to be asked. In the case of drop-out, the system usability scale [SUS] (Brooke, 1996), Fragebogen zur Messung der Patientenzufriedenheit [ZUF-8] (Schmidt & Nübling, 2002) and self-generated items will be queried.	—

Measure

Time frame

The main objective is to find out who starts Make It, who finishes it completely, who finishes it prematurely and who benefits from it. Demographic and medical data are collected before the start of training (T0). Furthermore, data on usability, feasibility and sustainability will be collected. After completion of the training (T1), the system usability scale [SUS] (Brooke, 1996), Fragebogen zur Messung der Patientenzufriedenheit [ZUF-8] (Schmidt & Nübling, 2002) and self-generated items will be queried. Furthermore, reasons for drop-out are to be asked. In the case of drop-out, the system usability scale [SUS] (Brooke, 1996), Fragebogen zur Messung der Patientenzufriedenheit [ZUF-8] (Schmidt & Nübling, 2002) and self-generated items will be queried.

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Secondary

Measure	Time frame
Secondary research questions refer to first assays on the efficacy of Make It with respect to depression, anxiety, distress, QoL, self-efficacy, mindfulness and stress perception. Before the training (T0) Right after the training (T1) Follow-up 1 (T2) Follow-up 2 (T3) In case of dropout Distress Thermometer (Mehnert, Müller, Lehmann, & Koch, 2006) Patient Health Questionnaire Depression Scale [PHQ-8] (Kroenke et al., 2009) Generalized Anxiety Disorder Scale-7 [GAD-7] (Spitzer, Kroenke, Williams, & Löwe, 2006) Skala zur Allgemeinen Selbstwirksamkeitserwartung [SWE] (Schwarzer, & Jerusalem, 1999) Freiburger Fragebogen zur Achtsamkeit [FFA-14] (Walach et al., 2006) Perceived Stress Questionnaire [PSQ] (Fliege et al., 2001) Functional Assessment of Cancer Therapy – General [FACT-G] (Cella et al., 1993) Die European Quality of Life 5 Dimensions 3 Level Version [EQ-5D-3L] (The EuroQoL Group, 1990) Also of interest is whether the attitude towards online interventions has an influence on outcomes and to what extent the attitude has changed after the end of the Make It Training. The Attitudes towards Psychological Online Interventions [APOI] (Schröder et al., 2015) is used for this purpose.	—

Measure

Time frame

Secondary research questions refer to first assays on the efficacy of Make It with respect to depression, anxiety, distress, QoL, self-efficacy, mindfulness and stress perception. Before the training (T0) Right after the training (T1) Follow-up 1 (T2) Follow-up 2 (T3) In case of dropout Distress Thermometer (Mehnert, Müller, Lehmann, & Koch, 2006) Patient Health Questionnaire Depression Scale [PHQ-8] (Kroenke et al., 2009) Generalized Anxiety Disorder Scale-7 [GAD-7] (Spitzer, Kroenke, Williams, & Löwe, 2006) Skala zur Allgemeinen Selbstwirksamkeitserwartung [SWE] (Schwarzer, & Jerusalem, 1999) Freiburger Fragebogen zur Achtsamkeit [FFA-14] (Walach et al., 2006) Perceived Stress Questionnaire [PSQ] (Fliege et al., 2001) Functional Assessment of Cancer Therapy – General [FACT-G] (Cella et al., 1993) Die European Quality of Life 5 Dimensions 3 Level Version [EQ-5D-3L] (The EuroQoL Group, 1990) Also of interest is whether the attitude towards online interventions has an influence on outcomes and to what extent the attitude has changed after the end of the Make It Training. The Attitudes towards Psychological Online Interventions [APOI] (Schröder et al., 2015) is used for this purpose.

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Countries

Germany

Contacts

Public ContactAlexander Bäuerle

Klinik für Psychosomatische Medizin und Psychotherapie am LVR-Klinikum Essen, Universität Duisburg-Essen.

alexander.baeuerle@uni-due.de0201 7227-323

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026