Clinical trial · Observational
Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Care Needs of Patients and Their Relatives
Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Psycho-oncological Care Needs of Patients and Their Relatives Stratified by Biopsychosocial Factors (LUPE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients
- label
- Relatives
Primary outcomes (5)
- measure
- Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time
- timeFrame
- after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
- description
- SCID (Structured Clinical Interview)
- measure
- Frequency and extent of psychological distress (Depression) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time
- timeFrame
- after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
- description
- PHQ (Patient Health Questionnaire - Depression)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDSpringer F, Ernst J, Goerling U, Koditz AK, Zimmermann T, Fujimori M, Koschig M, Riedel-Heller S, Uchitomi Y, Stein J, Mehnert-Theuerkauf A. Age-related patterns of loneliness during early cancer survivorship, risk factors, and associated health outcomes. J Psychosom Res. 2026 Aug 10;211:112959. doi: 10.1016/j.jpsychores.2026.112959. Online ahead of print. PMID 42594490
- DERIVEDMehnert-Theuerkauf A, Goerling U, Zimmermann T, Ernst J, Hermann M, Hornemann B, Keilholz U, Lordick F, Knesebeck OVD, Kissane D, Koditz AK, Springer F. Early Cancer Survivorship Distress Trajectories Associated With Socioeconomic Status and Age: Findings From a Multicenter Prospective Study. Cancer Med. 2025 Aug;14(15):e71076. doi: 10.1002/cam4.71076. PMID 40747744
- DERIVEDMehnert-Theuerkauf A, Hufeld JM, Esser P, Goerling U, Hermann M, Zimmermann T, Reuter H, Ernst J. Prevalence of mental disorders, psychosocial distress, and perceived need for psychosocial support in cancer patients and their relatives stratified by biopsychosocial factors: rationale, study design, and methods of a prospective multi-center observational cohort study (LUPE study). Front Psychol. 2023 Apr 20;14:1125545. doi: 10.3389/fpsyg.2023.1125545. eCollection 2023. PMID 37151329