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

• Conditions: C19; C20; C00-C14; C30; C31; C32; C23; C24; Malignant neoplasm of ovary; Malignant neoplasm of breast

• Registration Number: DRKS00007536
• Lead Sponsor: niversität Leipzig, Universitäres Krebszentrum Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-27
• Results First Posted: 2016-03-30
• Study Completion: 2018-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 502

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
What?: Burden by symptoms<br>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<br>How?: FACIT - questionnaire<br><br>What?: Care Needs<br>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<br>How?: SCNS-34 - questionnaire (in condensed form)<br><br>What?: Stress<br>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<br>How?: Distress Thermometer

Secondary Outcome Measures

Name	Time	Method
What?: Psychic comorbidity<br>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<br>How?: PHQ4 questionnaire<br><br>What?: Quality of Life<br>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<br>How?: SEIQol-Q questionnaire