Cancer Disease, Palliative TherapyAPM-ProjectNCT02751723
Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease
An observational study of Cancer Disease, Palliative Therapy, run by Florian Lordick, MD at 21 sites in Germany.
Trial summary
The aim of this non-investigational study is to determine the symptoms and disease burden at the time point of diagnosis and in the further course of an incurable cancer disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Disease, Palliative Therapy
- What is being tested?
- validated questionnaires
- How many people
- 500 participants
- Where
- 21 sitesGermany
- Study dates
- Sep 2014to Oct 2019
- 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 newly diagnosed incurable cancer disease before start of any tumor therapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Germany21 sites
Municipal Hospital Braunschweig
Braunschweig
Internal medicine practice
Burgwedel
Municipal Hospital Essen-Mitte
Essen
University of Essen
Essen
University of Göttingen
Göttingen
University of Hamburg-Eppendorf
Hamburg
Medical University Hanover
Hanover
Clinic for Thoraric Diseases (Thoraxklinik)
Heidelberg
Municipal Hospital Karlsruhe
Karlsruhe
UCCL, University of Leipzig
Leipzig, Saxony, 04103
University of Leipzig, ENT
Leipzig
Hospital Leverkusen
Leverkusen
Municipal Hospital Magdeburg
Magdeburg
University of Mainz
Mainz
Maria Hilf Clinic
Mönchengladbach
Radiotherapy practice
Recklinghausen
University of Regensburg
Regensburg
Hospital Südstadt Rostock
Rostock
Immanuel Hospital Rüdersdorf
Rüdersdorf
Hospital Traunstein
Traunstein
Comprehensive Cancer Centre Main-Franken
Würzburg
About this study
The aim of this non-investigational study is to determine the symptoms and disease burden at the time point of diagnosis and in the further course of an incurable cancer disease. The needs and preferences of patients suffering from cancer (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) are examined by various validated questionnaires. The data obtained by these questionnaires are collected together with information obtained by the treating physicians at four time points during the study: t0 - patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 - 3 months after patient´s enrollment; T2 - 6 months after patient´s enrollment; T3 - 12 months after patient´s enrollment. This highly innovative project offers the chance to identify medical services deficits and risk circumstances for the burden of treatments in an oncology-palliative setting and to optimize the quality of patient care.
- Conditions
- Cancer Disease, Palliative Therapy
- Being tested
- validated questionnaires
- Keywords
- cancer disease, palliative care, palliative therapy, cancer, patient´s needs, patient care, disease burden
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validated questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| lung cancer | validated questionnaires Receives: Other: validated questionnaires | |
| malignant melanoma | validated questionnaires Receives: Other: validated questionnaires | |
| cancer of the hepatobiliary system | validated questionnaires Receives: Other: validated questionnaires | |
| head and neck cancer | validated questionnaires Receives: Other: validated questionnaires | |
| breast cancer | validated questionnaires Receives: Other: validated questionnaires | |
| ovarian carcinoma | validated questionnaires Receives: Other: validated questionnaires | |
| pancreatic cancer | validated questionnaires Receives: Other: validated questionnaires | |
| stomach cancer | validated questionnaires Receives: Other: validated questionnaires | |
| oesophageal cancer | validated questionnaires Receives: Other: validated questionnaires | |
| colorectal cancer | validated questionnaires Receives: Other: validated questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Patient´s answers regarding symptom burden at 12 months
Measured: 12 months after enrollment
Secondary outcomes (5)
Change from Baseline physician´s report at 12 months
Measured: 12 months after enrollment
Change from Baseline Patient´s answers regarding symptom burden at 6 months
Measured: 6 months after enrollment
Change from Baseline physician´s report at 6 months
Measured: 6 months after enrollment
Change from Baseline Patient´s answers regarding symptom burden at 3 months
Measured: 3 months after enrollment
Change from Baseline physician´s report at 3 months
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Disease, Palliative TherapyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florian Lordick, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Florian Lordick, MD, University of Leipzig
- Investigators
- Florian Lordick, Prof. Dr., Study chair, University of LeipzigBend Alt-Epping, PD Dr., Study chair, University of GöttingenAnja Mehnert, Prof. Dr., Study chair, University of LeipzigBirgitt van Oorschot, Prof. Dr., Study chair, Comprehensive Cancer Centre Main-Franken, WürzburgMichael Thomas, Prof. Dr., Study chair, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751723
- Sponsor's protocol ID
- APM Project
- Other IDs
- DRKS00007536
- Acronym
- APM-Project
- Status last verified
- Mar 2019
- First submitted
- 14 Apr 2016
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease
- ClinicalTrials.gov ID
- NCT02751723
- Acronym / sponsor ID
- APM-Project / APM Project
- Conditions
- Cancer Disease, Palliative Therapy
- Keywords
- cancer disease, palliative care, palliative therapy, cancer, patient´s needs, patient care, disease burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Florian Lordick, MDUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 26 Apr 2016 (estimated)
- 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 aim of this non-investigational study is to determine the symptoms and disease burden at the time point of diagnosis and in the further course of an incurable cancer disease. The needs and preferences of patients suffering from cancer (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) are examined by various validated questionnaires. The data obtained by these questionnaires are collected together with information obtained by the treating physicians at four time points during the study: t0 - patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 - 3 months after patient´s enrollment; T2 - 6 months after patient´s enrollment; T3 - 12 months after patient´s enrollment. This highly innovative project offers the chance to identify medical services deficits and risk circumstances for the burden of treatments in an oncology-palliative setting and to optimize the quality of patient care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| lung cancer | – | Other: validated questionnairesvalidated questionnaires |
| malignant melanoma | – | Other: validated questionnairesvalidated questionnaires |
| cancer of the hepatobiliary system | – | Other: validated questionnairesvalidated questionnaires |
| head and neck cancer | – | Other: validated questionnairesvalidated questionnaires |
| breast cancer | – | Other: validated questionnairesvalidated questionnaires |
| ovarian carcinoma | – | Other: validated questionnairesvalidated questionnaires |
| pancreatic cancer | – | Other: validated questionnairesvalidated questionnaires |
| stomach cancer | – | Other: validated questionnairesvalidated questionnaires |
| oesophageal cancer | – | Other: validated questionnairesvalidated questionnaires |
| colorectal cancer | – | Other: validated questionnairesvalidated questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with newly diagnosed incurable cancer disease before start of any tumor therapy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| validated questionnaires | Other | breast cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer, lung cancer, malignant melanoma, oesophageal cancer, ovarian carcinoma, pancreatic cancer, stomach cancer |
Primary outcome
Change from Baseline Patient´s answers regarding symptom burden at 12 months
Time frame: 12 months after enrollment
5 secondary outcomes
Change from Baseline physician´s report at 12 months
Time frame: 12 months after enrollment
Change from Baseline Patient´s answers regarding symptom burden at 6 months
Time frame: 6 months after enrollment
Change from Baseline physician´s report at 6 months
Time frame: 6 months after enrollment
Change from Baseline Patient´s answers regarding symptom burden at 3 months
Time frame: 3 months after enrollment
Change from Baseline physician´s report at 3 months
Time frame: 3 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Cancer Disease, Palliative Therapy
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
Recruiting
Comprehensive Palliative Care After Stem Cell Transplantation: a Feasability Study
Hematopoietic Stem Cell Transplantation (HSCT)
Active, not recruiting
Shortened High-dose Palliative Radiotherapy for Lung Cancer
Stage IV Lung Cancer
Recruiting
Adding Spatially Fractionated Radiation Therapy to Standard Palliative Radiation for Improving Disease-Related Symptoms in Patients With Unresectable Solid Tumors
Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
RecruitingObservational study
Dexmedetomidine for Refractory Pain in Palliative Cancer Patients
Cancer, Palliative Care, Patient Care
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.
Florian Lordick, Prof. Dr. study chair
University of Leipzig
Bend Alt-Epping, PD Dr. study chair
University of Göttingen
Anja Mehnert, Prof. Dr. study chair
University of Leipzig
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Disease, Palliative Therapy, run by Florian Lordick, MD at 21 sites 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 3 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 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
Change from Baseline Patient´s answers regarding symptom burden at 12 months (time frame: 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.