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

Active, not recruiting

• Conditions: Neoplasm Malignant

• Registration Number: NCT04620564
• Lead Sponsor: University of Leipzig

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-09
• Primary Completion: 2022-09-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time	after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)	SCID (Structured Clinical Interview)
Frequency and extent of psychological distress (Anxiety) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time	after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)	GAD (Generalized Anxiety Disorder)
Frequency and extent of psychological distress (Depression) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time	after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)	PHQ (Patient Health Questionnaire - Depression)
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	after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)	EORTC (European Organisation for Research and Treatment of Cancer - Quality of life)

Secondary Outcome Measures

Name	Time	Method
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)	DCI (Dyadic Coping Inventar)

Trial Locations

Locations (1)

Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig; 🇩🇪 Leipzig, Saxony, Germany