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

NCT04620564 | Unknown

• 1 other identifier: DKH-70113544
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm Malignant

Keywords

psycho-oncology; psychological care; utilization; distress; mental disorders; neoplasm malignant; cancer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 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)

Other Outcomes (1)

• Adherence of the patients

  at follow up (Month 6)

Study Arms (2)

Patients

Relatives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with solid oncological tumors diagnosed no more than 4-8 weeks ago and meeting the inclusion criteria. The relatives of the patients do not have to meet any special inclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• presence of hematological cancers
• patients with cancer recurrence

Sponsors & Collaborators

• University of Leipzig: lead
• Charite University, Berlin, Germany: collaborator
• Hannover Medical School: collaborator
• German Cancer Aid: collaborator

Study Sites (1)

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

Leipzig, Saxony, 04103, Germany

Location

Related Publications (2)

• 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.

  PMID: 40747744 DERIVED

• 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.

  PMID: 37151329 DERIVED

MeSH Terms

Conditions

Neoplasms; Patient Acceptance of Health Care; Mental Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Anja Mehnert-Theuerkauf, Prof

  Universitätsklinikum Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: November 9, 2020
• Study Start: January 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

DE (1)