Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Care Needs of Patients and Their Relatives

Study Overview
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Brief Summary
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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.

Official Title
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Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Psycho-oncological Care Needs of Patients and Their Relatives Stratified by Biopsychosocial Factors (LUPE)

Conditions
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Neoplasm Malignant

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br> | |
| Relatives<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time | SCID (Structured Clinical Interview) | after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18) | 
| Frequency and extent of psychological distress (Depression) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time | PHQ (Patient Health Questionnaire - Depression) | after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18) | 
| Frequency and extent of psychological distress (Anxiety) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time | GAD (Generalized Anxiety Disorder) | after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18) | 
| Use of psycho-oncological support services by patients and relatives and the changes over time |  | 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 | EORTC (European Organisation for Research and Treatment of Cancer - Quality of life) | after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protective factors and stress-increasing risk factors within the dyad of relatives and the changes over time | DCI (Dyadic Coping Inventar) | after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, psycho-oncology, psychological care, utilization, distress, mental disorders, neoplasm malignant