Decision Aid to Support Advanced Cancer Patients
PETUPAL
Preference-based Decision Aid to Support Participatory Decisions About Tumor-specific and Palliative Therapy in the Last Months of Life
1 other identifier
interventional
70
1 country
1
Brief Summary
To support advanced cancer patients, for whom standard therapy is no longer available, and their oncologists in therapy decisions, the investigators aim to develop a decision-making aid (DA) in a multi-phased bicentric study. The DA aims to help patients to understand better risks and benefits of available treatment options including the options of standard palliative care, off-label drug use within an individual treatment plan and involvement in early clinical trials.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedJanuary 10, 2023
January 1, 2023
3.3 years
October 6, 2020
January 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Level of decisional conflict
Level of decisional conflict will be measured with the Decision Conflict Scale that assesses patients' perceptions of uncertainty, modifiable factors con-tributing to uncertainty, and ultimate satisfaction with the choice. It is one of the most robust and validated instruments to test the impact of decision aids also in end-of-life decision making. It has 16 items and 5 response categories, ranging from "0" -strongly agree till "4"-strongly disagree
Baseline
Level of decisional conflict
Level of decisional conflict will be measured with the Decision Conflict Scale that assesses patients' perceptions of uncertainty, modifiable factors con-tributing to uncertainty, and ultimate satisfaction with the choice. It is one of the most robust and validated instruments to test the impact of decision aids also in end-of-life decision making. It has 16 items and 5 response categories, ranging from "0" -strongly agree till "4"-strongly disagree
26 weeks
Secondary Outcomes (12)
Patients' involvement in decision-making
Baseline
Patients' involvement in decision-making
26 weeks
The trade-off between patients' preferences for quality and length of life
Baseline
The trade-off between patients' preferences for quality and length of life
26 weeks
Preferred role of the patient in decision-making
Baseline
- +7 more secondary outcomes
Study Arms (2)
Group without DA
NO INTERVENTIONadult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage.
Group with DA
OTHERadult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage.
Interventions
Oncologists and patients will use the decision aid in the same situation (change of treatment needs to be discussed with the patient - either because of disease progression or treatment toxicity or other reasons (e.g. change of care setting).
Eligibility Criteria
You may qualify if:
- Patients:
- adult patients with incurable, stage IV disease in an advanced treatment stage (prognosis \<12 months and/or standard palliative care);
- adequate level of German language;
- willing and able to give informed consent for participation in the study.
You may not qualify if:
- Patients that already are under standard palliative care only;
- are cognitive impaired;
- have extreme anxiety or distress;
- have a severe comorbid illness excluding antitumor treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Heidelberglead
- Martin-Luther-Universität Halle-Wittenbergcollaborator
- Heidelberg Universitycollaborator
- University of Jenacollaborator
- Bielefeld Universitycollaborator
Study Sites (1)
University Hospital Heidelberg
Heidelberg, 69120, Germany
Related Publications (1)
Laryionava K, Schildmann J, Wensing M, Wedding U, Surmann B, Woydack L, Krug K, Winkler E. Development and Evaluation of a Decision Aid to Support Patients' Participatory Decision-Making for Tumor-Specific and Palliative Therapy for Advanced Cancer: Protocol for a Pre-Post Study. JMIR Res Protoc. 2021 Sep 17;10(9):e24954. doi: 10.2196/24954.
PMID: 34533464DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Dr. phil. Director of the NCT-EPOC Programme (Ethics and Patient oriented Care) at the National Center for Tumor Diseases
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 28, 2020
Study Start
October 1, 2019
Primary Completion
February 1, 2023
Study Completion
April 1, 2023
Last Updated
January 10, 2023
Record last verified: 2023-01