Neoplasm MalignantLUPENCT04620564
Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Care Needs of Patients and Their Relatives
An observational study of Neoplasm Malignant, run by University of Leipzig at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- presence of hematological cancers
- patients with cancer recurrence
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig
Leipzig, Saxony, 04103
About this study
Official title: 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).
Read more
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.
- Conditions
- Neoplasm Malignant
- Keywords
- psycho-oncology, psychological care, utilization, distress, mental disorders, neoplasm malignant, cancer
- Medical subject headings
- Neoplasms, Patient Acceptance of Health Care, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described | |
| Relatives | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
Secondary outcomes (1)
Protective factors and stress-increasing risk factors within the dyad of relatives and the changes over time
DCI (Dyadic Coping Inventar)
Measured: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Jan 2020
- Primary completion30 Sep 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Hannover Medical School, German Cancer Aid
- Responsible party
- Principal investigator, Anja Mehnert, University of Leipzig
- Investigators
- Anja Mehnert-Theuerkauf, Prof, Principal investigator, Universitätsklinikum Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04620564
- Sponsor's protocol ID
- DKH-70113544
- Acronym
- LUPE
- Status last verified
- May 2023
- First submitted
- 5 Oct 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Springer F, Ernst J, Goerling U, Koditz AK, Zimmermann T, Fujimori M, Koschig M, Riedel-Heller S, Uchitomi Y, Stein J, Mehnert-Theuerkauf A. Age-related patterns of loneliness during early cancer survivorship, risk factors, and associated health outcomes. J Psychosom Res. 2026 Aug 10;211:112959. doi: 10.1016/j.jpsychores.2026.112959. Online ahead of print.
PubMed 42594490Mehnert-Theuerkauf A, Goerling U, Zimmermann T, Ernst J, Hermann M, Hornemann B, Keilholz U, Lordick F, Knesebeck OVD, Kissane D, Koditz AK, Springer F. Early Cancer Survivorship Distress Trajectories Associated With Socioeconomic Status and Age: Findings From a Multicenter Prospective Study. Cancer Med. 2025 Aug;14(15):e71076. doi: 10.1002/cam4.71076.
PubMed 40747744Mehnert-Theuerkauf A, Hufeld JM, Esser P, Goerling U, Hermann M, Zimmermann T, Reuter H, Ernst J. Prevalence of mental disorders, psychosocial distress, and perceived need for psychosocial support in cancer patients and their relatives stratified by biopsychosocial factors: rationale, study design, and methods of a prospective multi-center observational cohort study (LUPE study). Front Psychol. 2023 Apr 20;14:1125545. doi: 10.3389/fpsyg.2023.1125545. eCollection 2023.
PubMed 37151329
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Analysis of Mental Disorders, Psychosocial Distress and Psycho-oncological Care Needs of Patients and Their Relatives Stratified by Biopsychosocial Factors (LUPE)
- ClinicalTrials.gov ID
- NCT04620564
- Acronym / sponsor ID
- LUPE / DKH-70113544
- Conditions
- Neoplasm Malignant
- Keywords
- psycho-oncology, psychological care, utilization, distress, mental disorders, neoplasm malignant, cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Hannover Medical School, German Cancer Aid
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | – |
| Relatives | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- presence of hematological cancers
- patients with cancer recurrence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time
Time frame: 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 (Depression) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time
Time frame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
PHQ (Patient Health Questionnaire - Depression)
Frequency and extent of psychological distress (Anxiety) (subjective psycho-oncological support needs) in cancer patients and their relatives and the changes over time
Time frame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
GAD (Generalized Anxiety Disorder)
Use of psycho-oncological support services by patients and relatives and the changes over time
Time frame: 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
Time frame: 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)
1 secondary outcome
Protective factors and stress-increasing risk factors within the dyad of relatives and the changes over time
Time frame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Derived from this study: PubMed 42594490Springer F, Ernst J, Goerling U, Koditz AK, Zimmermann T, Fujimori M, Koschig M, Riedel-Heller S, Uchitomi Y, Stein J, Mehnert-Theuerkauf A. Age-related patterns of loneliness during early cancer survivorship, risk factors, and associated health outcomes. J Psychosom Res. 2026 Aug 10;211:112959. doi: 10.1016/j.jpsychores.2026.112959. Online ahead of print.
- Derived from this study: PubMed 40747744Mehnert-Theuerkauf A, Goerling U, Zimmermann T, Ernst J, Hermann M, Hornemann B, Keilholz U, Lordick F, Knesebeck OVD, Kissane D, Koditz AK, Springer F. Early Cancer Survivorship Distress Trajectories Associated With Socioeconomic Status and Age: Findings From a Multicenter Prospective Study. Cancer Med. 2025 Aug;14(15):e71076. doi: 10.1002/cam4.71076.
- Derived from this study: PubMed 37151329Mehnert-Theuerkauf A, Hufeld JM, Esser P, Goerling U, Hermann M, Zimmermann T, Reuter H, Ernst J. Prevalence of mental disorders, psychosocial distress, and perceived need for psychosocial support in cancer patients and their relatives stratified by biopsychosocial factors: rationale, study design, and methods of a prospective multi-center observational cohort study (LUPE study). Front Psychol. 2023 Apr 20;14:1125545. doi: 10.3389/fpsyg.2023.1125545. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Mehnert-Theuerkauf, Prof principal investigator
Universitätsklinikum Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm Malignant, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of mental disorders according to the DSM-5 (objective need for psycho-oncological support) in cancer patients and the changes over time (time frame: after the diagnosis (up to 8 weeks) and at every follow up (Month 6, Month 12, Month 18)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04620564, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.