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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasm Malignant

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Anja Mehnert-Theuerkauf, Prof; Phone Number: 0049 431 9718880; Email: anja.mehnert@medizin.uni-leipzig.de
• Study Contact Backup: Name: Jochen Ernst, Prof; Phone Number: 0049 341 9715415; Email: jochen.ernst@medizin.uni-leipzig.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients
Relatives

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence of the patients	AAQ (Adherence Assessment Questionnaire)	at follow up (Month 6)

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Charite University, Berlin, Germany; Hannover Medical School; German Cancer Aid
• Investigators: Principal Investigator: Anja Mehnert-Theuerkauf, Prof, Universitätsklinikum Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): September 30, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: cancer; distress; mental disorders; utilization; psycho-oncology; neoplasm malignant; psychological care
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Neoplasms; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: DKH-70113544

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No