Systematic recording of disease experiences and treatment outcomes of patients with malignant and rheumatic diseases in the MalheuR project

Systematic recording of disease experiences and treatment outcomes of patients with malignant and rheumatic diseases in the MalheuR project - PROMalheuR

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036690

Enrollment

1000

Registered

2025-06-05

Start date

2025-06-05

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Combination of C00-D48 and one of the M-/L-codes mentioned prerequisite for admission to study C00-D48 M05-M14 M30-M36 M45 M60 M65 L40.5 M46

Interventions

Group 1: Main module 1: Onboard module: One-time survey with electronic or paper-based questionnaires on patient-reported outcomes (PROs: current well-being, quality of life (EQ-5D-5L), patient journ

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: In general: - Written informed consent - Concurrent malignant and rheumatic disease (including pre-cancerous lesions, paraneoplasia and rheumatic side effects of oncological therapies, analogous to the inclusion criteria of the MalheuR project) - Written informed consent for the MalheuR project (S-391/2018; DRKS00036681 (registration requested)) Onboard module: - Pre-enrolled patients in the MalheuR project registry ConCenTRiC module: - First consultation at the MalheuR clinic DiGA module: - Indication of interest to participate in this optional module in the consent form Interview module: - Indication of interest to participate in this optional module in the consent form - Separate written consent from the patient to the collaborating partner performing the interviews

Exclusion criteria

Exclusion criteria: In general: - Refusal to give consent to the MalheuR project - Minors - Patients unable to give consent - Patients with only malignant or only rheumatic underlying disease

Design outcomes

Primary

Measure	Time frame
1.1 Onboard module: Detection of interindividual differences in patient-reported outcomes (PROs) of rheumatology patients with versus without malignant comorbidity (cumulative data of the reference cohort SCREENED 2.0 study S-549/2022) in one-time collection of PROs on current well-being, quality of life (EQ-5D-5L), patient journey and vaccination behavior. 1.2 ConCenTRiC module: Intra-individual improvement of patient-reported outcomes (PROs) immediately after the telemedical (“offsite”) or on-site (“onsite”) consultation compared to the initial state (T1 versus T0) in PROs on current well-being, quality of life (EQ-5D-5L), physical functions (FFbH, PROMIS) and other PROMIS domains.	—

Measure

Time frame

1.1 Onboard module: Detection of interindividual differences in patient-reported outcomes (PROs) of rheumatology patients with versus without malignant comorbidity (cumulative data of the reference cohort SCREENED 2.0 study S-549/2022) in one-time collection of PROs on current well-being, quality of life (EQ-5D-5L), patient journey and vaccination behavior. 1.2 ConCenTRiC module: Intra-individual improvement of patient-reported outcomes (PROs) immediately after the telemedical (“offsite”) or on-site (“onsite”) consultation compared to the initial state (T1 versus T0) in PROs on current well-being, quality of life (EQ-5D-5L), physical functions (FFbH, PROMIS) and other PROMIS domains.

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Secondary

Measure	Time frame
2.1 Onboard module: Interindividual differences in a) patient-reported outcomes (PROs, matched case-control analysis) and b) health and care indicators (cumulative and matched) of rheumatology patients with versus without malignant comorbidity (reference cohort S-549/2022) 2.2 ConCenTRiC module: - Physician time spent on initial consultations for onsite versus offsite patients - Intraindividual changes in PROs in the follow-up of onsite and offsite patients - Interindividual differences in a) PROs and b) health and care indicators after onsite versus offsite initial consultation - Comparison of group-specific differences in PROs, health and care indicators with a) onboard module and b) reference cohort without malignant comorbidity (S-549/2022): - Satisfaction of patients and referring physicians with the initial consultation - Saving of driving kilometers through telemedical consultation 2.3 DiGA module: - Utilisation of the DiGA offer - Patient-reported individual added value and intraindividual changes in the PROs during follow-up by the use of a DiGA - Group-specific differences in the PROs and in the patient-reported DiGA added value according to DiGA preference and main module affiliation - Comparison of the patient-reported individual added value by the use of a DiGA with an external rheumatological reference cohort without malignant comorbidity (DiGAReal register, Ethics vote 22-113-1-B of the Medical Faculty of the University of Erlangen-Nuremberg). 2.4. Interview module: - qualitative collection of patient journey of patients with concurrent malignant and rheumatic diseases - interindividual differences between Onboard and ConCenTRiC patients, and patients with rheumatic or malignant primary disease or rheumatic side effects of cancer therapy. 2.5 Cross-module - Correlation of identified differences in health and health care with PROs - Subgroup analyses of group-specific differences in PROs between depending on various d	—

Measure

Time frame

2.1 Onboard module: Interindividual differences in a) patient-reported outcomes (PROs, matched case-control analysis) and b) health and care indicators (cumulative and matched) of rheumatology patients with versus without malignant comorbidity (reference cohort S-549/2022) 2.2 ConCenTRiC module: - Physician time spent on initial consultations for onsite versus offsite patients - Intraindividual changes in PROs in the follow-up of onsite and offsite patients - Interindividual differences in a) PROs and b) health and care indicators after onsite versus offsite initial consultation - Comparison of group-specific differences in PROs, health and care indicators with a) onboard module and b) reference cohort without malignant comorbidity (S-549/2022): - Satisfaction of patients and referring physicians with the initial consultation - Saving of driving kilometers through telemedical consultation 2.3 DiGA module: - Utilisation of the DiGA offer - Patient-reported individual added value and intraindividual changes in the PROs during follow-up by the use of a DiGA - Group-specific differences in the PROs and in the patient-reported DiGA added value according to DiGA preference and main module affiliation - Comparison of the patient-reported individual added value by the use of a DiGA with an external rheumatological reference cohort without malignant comorbidity (DiGAReal register, Ethics vote 22-113-1-B of the Medical Faculty of the University of Erlangen-Nuremberg). 2.4. Interview module: - qualitative collection of patient journey of patients with concurrent malignant and rheumatic diseases - interindividual differences between Onboard and ConCenTRiC patients, and patients with rheumatic or malignant primary disease or rheumatic side effects of cancer therapy. 2.5 Cross-module - Correlation of identified differences in health and health care with PROs - Subgroup analyses of group-specific differences in PROs between depending on various d

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Countries

Germany

Contacts

Public ContactKarolina Gente

Universitätsklinikum Heidelberg - Innere Medizin V

malheur.MED5@med.uni-heidelberg.de+49 6221 56 8030

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026