Clinical trial NCT04620564: Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Care Needs of Patients and Their Relatives
Official title: Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Psycho-oncological Care Needs of Patients and Their Relatives Stratified by Biopsychosocial Factors (LUPE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasm Malignant
Keywords: psycho-oncology
psychological care
utilization
distress
mental disorders
neoplasm malignant
cancer
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Hannover Medical School
name: German Cancer Aid
First posted: 2020-11-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time
timeFrame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
measure: Frequency and extent of psychological distress (Depression) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time
timeFrame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
measure: Frequency and extent of psychological distress (Anxiety) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time
timeFrame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
measure: Use of psycho-oncological support services by patients and relatives and the changes over time
timeFrame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
measure: Changes in Quality of Life and the changes over time
timeFrame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
Secondary outcomes:
measure: Protective factors and stress-increasing risk factors within the dyad of relatives and the changes over time
timeFrame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
Other outcomes:
measure: Adherence of the patients
timeFrame: at follow up (Month 6)
Locations:
city: Leipzig
country: Germany
facility: Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig
state: Saxony
Study officials:
affiliation: Universitätsklinikum Leipzig
name: Anja Mehnert-Theuerkauf, Prof
role: PRINCIPAL_INVESTIGATOR
References: