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

Neoplasm Malignant Clinical Trial

— LUPE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04620564
• Other study ID #: DKH-70113544
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Neoplasm Malignant
• Neoplasms
• Psychotic Disorders

Locations

Country	Name	City	State
Germany	Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig	Leipzig	Saxony

Sponsors (4)

Lead Sponsor	Collaborator
University of Leipzig	Charite University, Berlin, Germany, German Cancer Aid, Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence of the patients	AAQ (Adherence Assessment Questionnaire)	at follow up (Month 6)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)