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

NCT ID: NCT04620564

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Neoplasm Malignant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

No interventions assigned to this group

Relatives

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role collaborator

German Cancer Aid

OTHER

Sponsor Role collaborator

University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Anja Mehnert

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anja Mehnert-Theuerkauf, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Leipzig

Locations

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Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

References

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Mehnert-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.

Reference Type DERIVED
PMID: 40747744 (View on PubMed)

Mehnert-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.

Reference Type DERIVED
PMID: 37151329 (View on PubMed)

Other Identifiers

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DKH-70113544

Identifier Type: -

Identifier Source: org_study_id

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