Web-based Mindfulness and Skills-Based Distress Reduction for cancer patients: A multi-center, randomized, controlled intervention study (Reduct).

Not Applicable

Recruiting

• Conditions: Psychological distress in cancer patients; Neoplasms; C00-D48

• Registration Number: DRKS00025213
• Lead Sponsor: Klinik für Psychosomatische Medizin und Psychotherapie am LVR-Klinikum Essen, Universität Duisburg-Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Confirmed diagnosis of cancer in the past 12 months, curative treatment setting, age 18-65 years, given informed consent, and high perceived distress (HADS = 13) for at least one week.

Exclusion Criteria

Patients with severe cognitive impairment and/or communication difficulties that compromise participation in the intervention, acute risk for suicide and/or severe depression according to clinical practice guidelines, other psychiatric or medical conditions requiring alternative treatment, known cerebral metastases, an age of > 65, no private internet access, and/or regularly contacting a mental health specialist will be excluded.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distress; HADS

Secondary Outcome Measures

Name	Time	Method
Self-efficacy (GSES);<br>Quality of life (EORTC-QLQ-C30 and EQ-5D-5L); <br>Mindfulness (FMI);<br>Distress over four assessment points (HADS);<br>Distress (DT);<br>Depressiveness and Anxiety (PHQ-4);<br>Internet use, user behavior and time to dropout;<br>Cost-effectiveness;<br>Predictors of usage (UTAUT);<br>User satisfaction (CSQ-I), Usability (SUS), <br>Coping skills (self-generated items)