Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Psycho-oncological Care Needs of Patients and Their Relatives Stratified by Biopsychosocial Factors (LUPE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasm Malignant
- Sponsor
- University of Leipzig
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objectives of this prospective observational multicenter study LUPE are to assess the prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support), psychosocial distress, psycho-oncological care needs and utilization of psycho-oncological support services (subjective need for support) of cancer patients and their relatives during the first months of cancer survivorship stratified by biopsychosocial factors including socioeconomic status. The investigators further aim to identify moderating and mediating as well as associated factors for psychological distress and supportive care needs.
LUPE will include 2000 adult patients with solid tumor entities and one relative per patient at 4 measurement points from time of diagnosis to follow-up (+18 months) (t1: after diagnosis, t2: 6 month later, t3: 6 month later, t4: 6 month later).
The investigators aim to generate a quota sample according to socioeconomic status (SES) that is representative of the German overall population.
All participants will receive validated self-report questionnaires. Cancer patients will be interviewed using the standardized clinical interview SCID-5.
Investigators
Anja Mehnert
Prof
University of Leipzig
Eligibility Criteria
Inclusion Criteria
- •Primary diagnosis of malignant solid tumor
- •a maximum time period after diagnosis of 4-8 weeks
- •minimum age of 18 years
- •cognitive ability to consent to study participation
Exclusion Criteria
- •presence of hematological cancers
- •patients with cancer recurrence
Outcomes
Primary Outcomes
Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time
Time Frame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
SCID (Structured Clinical Interview)
Frequency and extent of psychological distress (Anxiety) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time
Time Frame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
GAD (Generalized Anxiety Disorder)
Frequency and extent of psychological distress (Depression) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time
Time Frame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
PHQ (Patient Health Questionnaire - Depression)
Use of psycho-oncological support services by patients and relatives and the changes over time
Time Frame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
Changes in Quality of Life and the changes over time
Time Frame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
EORTC (European Organisation for Research and Treatment of Cancer - Quality of life)
Secondary Outcomes
- Protective factors and stress-increasing risk factors within the dyad of relatives and the changes over time(after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18))