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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Other: Decision Aid

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Winkler, Prof.; Phone Number: +49 622156-37216; Email: eva.winkler@med.uni-heidelberg.de

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • University Hospital Heidelberg
    • Contact: Eva Winkler; Phone Number: +4962215637216; Email: eva.winkler@med.uni-heidelberg.de
    • Sub-Investigator: Katsiaryna Laryionava, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group without DA; adult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage.
Other: Group with DA; adult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage.	Other: Decision Aid; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' involvement in decision-making	Patients' involvement in decision-making will be assessed with the German questionnaire on shared decision making. It has 9 items with 6-points Likert scale, ranging from "0-not at all" till "6 -fully correct". The higher score means more shared decision making.	Baseline
Patients' involvement in decision-making	Patients' involvement in decision-making will be assessed with the German questionnaire on shared decision making. It has 9 items with 6-points Likert scale, ranging from "0-not at all" till "6 -fully correct". The higher score means more shared decision making.	26 weeks
The trade-off between patients' preferences for quality and length of life	The trade-off between patients' preferences for quality and length of life will be assessed with the German validated version of "Quality and Quantity Questionnaire" The questionnaire consists of nine items in two preference dimensions: Q(uality) of life (QL) and L(ength) of life (LL). Patients indicate how strongly they agree or disagree with the statements on a 5-point Likert scale. High scores on the quantity or quality scale indicate the importance of length or quality of life, respectively.	Baseline
The trade-off between patients' preferences for quality and length of life	The trade-off between patients' preferences for quality and length of life will be assessed with the German validated version of "Quality and Quantity Questionnaire" The questionnaire consists of nine items in two preference dimensions: Q(uality) of life (QL) and L(ength) of life (LL). Patients indicate how strongly they agree or disagree with the statements on a 5-point Likert scale. High scores on the quantity or quality scale indicate the importance of length or quality of life, respectively.	26 weeks
Preferred role of the patient in decision-making	Preferred role of the patient in decision-making will be assessed with a German version of the Control Preference Scale (CPS). It consists of five statement (A, B, C, D, E) that each portrays a different role in treatment decision-making. For analysis a categorical variable, which is the person's most preferred role in treatment decision-making, will be created. Preference orders will be reclassified into Active (A, B), Collaborative ( C) and Passive (D, E). Ordinal categorical analysis can be applied.	Baseline
Preferred role of the patient in decision-making	Preferred role of the patient in decision-making will be assessed with a German version of the Control Preference Scale (CPS). It consists of five statement (A, B, C, D, E) that each portrays a different role in treatment decision-making. For analysis a categorical variable, which is the person's most preferred role in treatment decision-making, will be created. Preference orders will be reclassified into Active (A, B), Collaborative ( C) and Passive (D, E).Ordinal categorical analysis can be applied.	26 weeks
Satisfaction with the oncologist-patient interaction	Satisfaction with the oncologist-patient interaction will be assessed using the validated questionnaire on the Quality of Physician-Patient Interaction (QQPPI). It has 14 Items with a 5-point scale (range: 1 [I do not agree] to 5 [I fully agree]).	Baseline
Satisfaction with the oncologist-patient interaction	Satisfaction with the oncologist-patient interaction will be assessed using the validated questionnaire on the Quality of Physician-Patient Interaction (QQPPI). It has 14 Items with a 5-point scale (range: 1 [I do not agree] to 5 [I fully agree]).	26 weeks
Effect on hope	Effect on hope will be assessed with a German Version of the Herth Hope Index (HHI-D). It has 12 items with a 4-point Likert scale. Higher scores indicate more hope.	Baseline
Effect on hope	Effect on hope will be assessed with a German Version of the Herth Hope Index (HHI-D). It has 12 items with a 4-point Likert scale. Higher scores indicate more hope.	26 weeks
Effect on patients' quality of life	Quality of life will be assessed with the EORTC QLQ-C30, a questionnaire developed to measure the quality of life of cancer patients. The QLQ-C30 has global health status, five functional scales, and three symptom scales. High scores of functional scales means healthy functioning. A high score for global health status means a higher quality of life. A high score of symptom scales demonstrates a high level of problems. Scores for all scales and single items range from 0 to 100.	Baseline
Effect on patients' quality of life	Quality of life will be assessed with the EORTC QLQ-C30, a questionnaire developed to measure the quality of life of cancer patients. The QLQ-C30 has global health status, five functional scales, and three symptom scales. High scores of functional scales means healthy functioning. A high score for global health status means a higher quality of life. A high score of symptom scales demonstrates a high level of problems. Scores for all scales and single items range from 0 to 100.	26 weeks

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Collaborators: Heidelberg University; University of Jena; Martin-Luther-Universität Halle-Wittenberg; Bielefeld University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: advanced cancer; decision aid; forgoing of cancer treatment; patients' inclusion in clinical trials; pre-post design study
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: UHHeidelberg

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No