Clinical trial NCT04606238: Decision Aid to Support Advanced Cancer Patients
Official title: Preference-based Decision Aid to Support Participatory Decisions About Tumor-specific and Palliative Therapy in the Last Months of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Cancer
Keywords: decision aid
advanced cancer
forgoing of cancer treatment
patients' inclusion in clinical trials
pre-post design study
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: Martin-Luther-Universität Halle-Wittenberg
name: Heidelberg University
name: University of Jena
name: Bielefeld University
First posted: 2020-10-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Decisions about the provision of anticancer therapy and the initiation of palliative care in the last months of life are frequent and challenging in clinical practice. Research indicates that there is considerable heterogeneity regarding clinical practice in this context and that oncologists' values influence treatment decisions, as well as whether or not patients participate in these decisions. While there is evidence that seriously ill patients differ in their choices between treatment options compared to healthy persons, as well as in their evaluation of treatment goals and related care settings, there is a lack of analysis regarding criteria relevant to patients in the last 6 months of life, when assessing the benefit of anticancer treatment and palliative care. Yet, in decisions about anticancer treatment and involvement of palliative care, patients' preferences and values are of particular importance since anticancer treatment - while associated with high expectations for a positive effect - often has only marginal influence on prognosis towards the end of a cancer trajectory and sometimes forestalls choosing a palliative care setting or coping with the disease. Hence, the decision has a high impact on patients' last months of life. Involving patients more actively in the planning of their care has been on the agenda for more than a decade, but the implementation of this idea in routine clinical practice remains a challenge. Instead, oncologists often avoid prognosticating and eliciting patient preferences for or against anticancer treatment and values in the last phase of life. One important reason is that oncologists report discussions about ending anticancer therapy the most challenging communication task.

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.

Methods and analysis:

In phase I, the DA will be developed after exploration of decisional needs of patients and views of health care providers based on face-to face interviews and focus groups discussions. Subsequently, the DA will be alpha-tested and redrafted, as necessary, in phase II. In phase III, the DA will be (1) beta-tested with patients and oncologists and (2), and assessed by experts. In the last project phase, the investigators will run a pre-post design study with doctor-patient-encounters to access improvements on primary study outcome, i.e. patients' level of decisional conflict. In addition, the user acceptance will be tested.

Eligibility criteria: 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.

Primary outcomes:
measure: Level of decisional conflict
timeFrame: Baseline
measure: Level of decisional conflict
timeFrame: 26 weeks
Secondary outcomes:
measure: Patients' involvement in decision-making
timeFrame: Baseline
measure: Patients' involvement in decision-making
timeFrame: 26 weeks
measure: The trade-off between patients' preferences for quality and length of life
timeFrame: Baseline
measure: The trade-off between patients' preferences for quality and length of life
timeFrame: 26 weeks
measure: Preferred role of the patient in decision-making
timeFrame: Baseline
measure: Preferred role of the patient in decision-making
timeFrame: 26 weeks
measure: Satisfaction with the oncologist-patient interaction
timeFrame: Baseline
measure: Satisfaction with the oncologist-patient interaction
timeFrame: 26 weeks
measure: Effect on hope
timeFrame: Baseline
measure: Effect on hope
timeFrame: 26 weeks
measure: Effect on patients' quality of life
timeFrame: Baseline
measure: Effect on patients' quality of life
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
References:
citation: 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.