Determination of burden and requirements of therapies for patients during the course of incurable cancer disease

Determination of burden and requirements of therapies for patients during the course of incurable cancer disease - APM-Project

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00007536

Enrollment

500

Registered

2014-11-27

Start date

2014-12-22

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Incurable cancer disease (ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer) C56 C50 C43-C44 C34 C16 C15 C25 C22 C18 C19 C20 C00-C14 C30 C31 C32 C23 C24

Interventions

Group 1: patients suffering from cancer (ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, c

The aim of this non-investigational study is to determine the symptoms and burden at the moment of diagnosis and in the further course of an incurable cancer disease. The needs and preferences of pati

T1 – 3 months after the patient´s enrollment

T2 – 6 months after the patient´s enrollment

T3 – 12 months after the patient´s enrollment.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Incurable cancer disease: ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer - signed and dated Inform Consent Form - Age> 18 years

Exclusion criteria

Exclusion criteria: - Patient is not able to understand and to answer questions - Patient is in a critical health situation and is directly threatened due to cancer disease or the resulting complications

Design outcomes

Primary

Measure	Time frame
What?: Burden by symptoms When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: FACIT - questionnaire What?: Care Needs When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: SCNS-34 - questionnaire (in condensed form) What?: Stress When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: Distress Thermometer	—

Measure

Time frame

What?: Burden by symptoms When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: FACIT - questionnaire What?: Care Needs When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: SCNS-34 - questionnaire (in condensed form) What?: Stress When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: Distress Thermometer

—

Secondary

Measure	Time frame
What?: Psychic comorbidity When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: PHQ4 questionnaire What?: Quality of Life When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: SEIQol-Q questionnaire	—

Measure

Time frame

What?: Psychic comorbidity When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: PHQ4 questionnaire What?: Quality of Life When?: T0 – patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 – 3 months after the patient´s enrollment; T2 – 6 months after the patient´s enrollment; T3 – 12 months after the patient´s enrollment How?: SEIQol-Q questionnaire

—

Countries

Germany

Contacts

Public ContactJeannette Vogt

Universität Leipzig; UCCL

studienzentrale.uccl@medizin.uni-leipzig.de0341/9712573

Outcome results

None listed

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