Decision Aid to Support Advanced Cancer Patients

Advanced Cancer Clinical Trial

— PETUPAL  

Official title:

Preference-based Decision Aid to Support Participatory Decisions About Tumor-specific and Palliative Therapy in the Last Months of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04606238
• Other study ID #: UHHeidelberg
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: April 1, 2023

Study information

• Verified date: January 2023
• Source: University Hospital Heidelberg
• Contact: Eva Winkler, Prof.
• Phone: +49 622156-37216
• Email: eva.winkler[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Bielefeld University, Heidelberg University, Martin-Luther-Universität Halle-Wittenberg, University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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