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

University of Leipzig

Status: Active, not recruiting

Conditions: Neoplasm Malignant

Study type: Observational

Funder types: Other

Identifiers

NCT04620564

DKH-70113544

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Patients

Relatives