Advanced CancerPETUPALNCT04606238
Decision Aid to Support Advanced Cancer Patients
A study testing Decision Aid in people with Advanced Cancer, run by University Hospital Heidelberg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Decision Aid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg, 69120
Eva Winkler, +4962215637216, eva.winkler@med.uni-heidelberg.de
Katsiaryna Laryionava, Dr
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Cancer
- Being tested
- Decision Aid
- Keywords
- decision aid, advanced cancer, forgoing of cancer treatment, patients' inclusion in clinical trials, pre-post design study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Group without DA | No intervention | adult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage. |
| Group with DA | Other | adult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage. Receives: Other: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 26 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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]).
Measured: 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]).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Oct 2019
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, Heidelberg University, University of Jena, Bielefeld University
- Responsible party
- Principal investigator, Eva Winkler, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606238
- Sponsor's protocol ID
- UHHeidelberg
- Acronym
- PETUPAL
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Laryionava K, Boekels R, Schildmann J, Wensing M, Wedding U, Surmann B, Mehlis K, Gebel C, Cinci M, Krug K, Winkler EC. Feasibility of implementing a decision aid for advanced cancer patients in a comprehensive cancer centers' outpatient setting: Valuable lessons learned. Cancer Med. 2024 Dec;13(24):e70127. doi: 10.1002/cam4.70127.
PubMed 39690895Laryionava 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.
PubMed 34533464
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference-based Decision Aid to Support Participatory Decisions About Tumor-specific and Palliative Therapy in the Last Months of Life
- ClinicalTrials.gov ID
- NCT04606238
- Acronym / sponsor ID
- PETUPAL / UHHeidelberg
- Conditions
- Advanced Cancer
- Keywords
- decision aid, advanced cancer, forgoing of cancer treatment, patients' inclusion in clinical trials, pre-post design study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg, Heidelberg University, University of Jena, Bielefeld University
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group without DA | No intervention | –adult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage. |
| Group with DA | Other | Other: Decision Aidadult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidOncologists 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). | Other | Group with DA |
Primary outcome
Level of decisional conflict
Time frame: Baseline
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
Level of decisional conflict
Time frame: 26 weeks
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
12 secondary outcomes
Patients' involvement in decision-making
Time frame: Baseline
Patients' involvement in decision-making
Time frame: 26 weeks
The trade-off between patients' preferences for quality and length of life
Time frame: Baseline
The trade-off between patients' preferences for quality and length of life
Time frame: 26 weeks
Preferred role of the patient in decision-making
Time frame: Baseline
Preferred role of the patient in decision-making
Time frame: 26 weeks
Satisfaction with the oncologist-patient interaction
Time frame: Baseline
Satisfaction with the oncologist-patient interaction
Time frame: 26 weeks
Effect on hope
Time frame: Baseline
Effect on hope
Time frame: 26 weeks
Effect on patients' quality of life
Time frame: Baseline
Effect on patients' quality of life
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 39690895Laryionava K, Boekels R, Schildmann J, Wensing M, Wedding U, Surmann B, Mehlis K, Gebel C, Cinci M, Krug K, Winkler EC. Feasibility of implementing a decision aid for advanced cancer patients in a comprehensive cancer centers' outpatient setting: Valuable lessons learned. Cancer Med. 2024 Dec;13(24):e70127. doi: 10.1002/cam4.70127.
- Derived from this study: PubMed 34533464Laryionava 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Advanced Cancer, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Winkler, Prof. (+49 622156-37216, eva.winkler@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of decisional conflict (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606238, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.