Clinical trial · Interventional
Decision Aid to Support Advanced Cancer Patients
Preference-based Decision Aid to Support Participatory Decisions About Tumor-specific and Palliative Therapy in the Last Months of Life
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decision Aid | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Group without DA
- description
- adult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage.
- type
- OTHER
- label
- Group with DA
- description
- adult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage.
- interventionNames
- Other: Decision Aid
Primary outcomes (2)
- measure
- Level of decisional conflict
- timeFrame
- Baseline
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDLaryionava 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 34533464