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  • Periodic Report Summary 2 - ACTION (Advance Care Planning; an Innovative Palliative Care Intervention to Improve Quality of Life in CancerPatients - a Multi-Centre Cluster Randomized Clinical Trial)

ACTION Report Summary

Project ID: 602541
Funded under: FP7-HEALTH
Country: Netherlands

Periodic Report Summary 2 - ACTION (Advance Care Planning; an Innovative Palliative Care Intervention to Improve Quality of Life in CancerPatients - a Multi-Centre Cluster Randomized Clinical Trial)

Project Context and Objectives:
Despite progress in diagnosis and treatment, cancer remains a major life limiting disease, with 12.7 million new cases and 7.6 million cancer deaths worldwide in 2008. Patients with advanced cancer typically suffer from a reduced quality of life and multiple symptoms, such as pain, fatigue, and dyspnoea, due to their cancer diagnosis and/or its treatment. A diagnosis of advanced cancer often has a tremendous impact on patients’ emotional wellbeing, resulting in depression, anxiety and a feeling of loss of control. Medical care for patients with advanced cancer should be aimed at symptom control, psychosocial support, spiritual needs, and practical issues. Patients’ preferences regarding care and their wishes concerning their place of residence should be central. Currently, treatment aimed at prolonging life has been found to often prevail over care aimed at relieving patients’ suffering and enhancing their quality of life, which may not always be in accordance with patients’ needs.

Timely and efficient communication is an important prerequisite for appropriate care that adequately addresses patients’ needs and preferences. However, research findings consistently demonstrate that communication between physicians, patients with advanced cancer, and their relatives is complex. Physicians are often uncertain about their patients’ values and preferences, and relatives may feel stressed, uncertain, and reluctant to relinquish treatment aimed at sustaining life, even if cure is no longer possible.

Advance care planning (ACP) is a formalized process of communication between patients, relatives and professional caregivers. It has been defined as “a voluntary process of discussion and review enabling individuals to express, and, if they wish, record views, values and specific treatment choices to inform their future care”. ACP promotes the documentation of patients’ preferences in their medical file, the communication of these preferences to family, friends, and healthcare professionals, and the periodic review of preferences as circumstances change. It has the potential to empower patients, to foster autonomy, to improve the quality of decision making for patients and relatives, to increase the extent to which care is addressing patients’ needs and preferences, and to reduce patients’ symptom burden. ACP might also improve communication between patients and healthcare professionals and reduce futile treatments and unnecessary hospitalizations. Other studies also show it has reduced costs. Respecting Choices has turned out to be one of the most promising ACP programs. In this program, a trained facilitator in collaboration with attending physicians encourages patients to reflect on their goals, values and beliefs, to discuss and document their future choices, and to appoint a surrogate decision maker.

Most ACP studies have been performed amongst older nursing home patients with the main aim of establishing patients’ preferences before they lose their competence. We hypothesize that ACP can also be effective in improving the quality of life of competent patients with advanced cancer, because it supports them in timely recognizing and expressing their needs and preferences which will enable strategic and effective planning of care and decision-making. As a result, care will more adequately address patients’ needs and preferences, resulting in improved quality of life and more adequate symptom control, while patients feel more in control and receive less unwanted, futile interventions.

Overall hypothesis
Formalised Advance Care Planning significantly improves quality of life and reduces symptoms of patients with advanced cancer.

The primary objective is to assess the effect of the Respecting Choices ACP program on the quality of life and symptoms of patients with advanced lung or colo-rectal cancer.

The secondary objectives are:
1. To assess the effect of the Respecting Choices ACP program on the quality of life and symptoms of patients with advanced cancer in different subgroups (gender, age, education, ethnicity, country and type of cancer).
2. 2. To assess the effect of the Respecting Choices ACP program on the extent to which care as received is in line with patients’ documented preferences, on patients’ evaluation of the quality of the decision-making process, and on how they cope with their illness.
3. To assess patient satisfaction with the Respecting Choices ACP program.
4. To assess the effect of the Respecting Choices ACP program on the quality of end of life care of patients with advanced cancer from the bereaved carers’ perspective, and on the wellbeing of these carers.
5. To assess the cost effectiveness of the Respecting Choices ACP program.
6. To gain insight into how patients, patients’ relatives and professional caregivers experience and respond to facilitated ACP.

Project Results:
WP1/Erasmus MC:

Dec 2013 – May 2015:
Activities and progress towards the deliverables of all WPs have been monitored and evaluated. An Ombudsman and a Data and Safety Monitoring Committee have been installed. Steering Committee meetings and Consortium meetings have been organized regularly. Communication with other relevant projects around the globe has been established. Randomisation of the hospitals into either intervention or control arm took place and the recruitment of patients into the study is closely monitored.

Jun 2015 – Nov 2016:
The monitoring and evaluation of activities and the progress towards the deliverables of all WPs has been continued. We organized and followed-up on the meetings of the Steering Committee, the Consortium, and the data safety monitoring committee (DSMC). We kept contact with other relevant projects around the globe. We are closely monitoring patient recruitment, others e.g. through regular telephone meetings with each of the consortium partners.


Dec 2013 – May 2015:
The questionnaires went through the formal and comprehensive translation process as described by the EORTC Quality of Life Group. The interview guides, the My Preferences form and the leaflets have been carefully translated into Italian, Slovene, Dutch, Belgian Dutch and Danish. As the intervention has been modified on several occasions both before and after the pilot testing of the intervention, several translations (of certain sentences or sections) have also been made during the process.

A pilot study of the intervention has been performed from 17th of November 2014 to 13th of January 2015. We gained insight into how patients, their carers, facilitators and other health care professionals experienced the ‘Respecting Choices’ intervention and the questionnaires. We were also able to test the logistics behind the intervention, e.g. the steps and procedures of the recruitment. The results were summarized and discussed with the consortium. According to the results from the pilot testing, adaptions have been made in the intervention materials as well as the questionnaires.

As a result of the work carried out by the ACTION consortium the intervention materials and the questionnaires applied in the ACTION trial went through a comprehensive translation process in all research teams either following the formal EORTC Quality of Life Group guidelines or informal and careful translation procedures. As an outcome of this process, quality translations of the key intervention materials and questionnaires have been made. Also, the testing of the intervention resulted in valuable knowledge, which has made it possible to further and successfully adapt the intervention (both conversation guides and the My Preferences form) to European patients with lung and colorectal cancer. As a result, the intervention was ready to be applied in the ACTION trial.

Jun 2015 – Nov 2016:
As the planned work was completed before December 2015, no additional practical work was required WP2. A manuscript documenting the development, testing and adaptation of the intervention is currently being prepared in collaboration with all consortium partners.


Dec 2013 – May 2015:
WP3 coordinated and monitored the education of the facilitators. Representatives from each partner have been trained in La Crosse/ WI (USA) to become certified teachers of the Respecting Choices program in their home country.
Since the training in May 2015 regular teleconferences with the teachers were held and chaired by WP3. The conferences were used to establish common development of the teachers’ skills. Core materials of the intervention (the Interview Guides and the My Preferences form) and educational materials were discussed and adapted according to legal, cultural, ethical and clinical practice conditions of each country and in close collaboration with the Respecting Choices team in the US. The materials have been reviewed after the feasibility study.

In January 2015 a Mock-training took place in Rotterdam under supervision of the Respecting Choices instructor Linda Briggs. The aim of this training was to refine the program and materials and to unify the knowledge and skills of the teachers.
Standardized workshops for the future facilitators took place in each country. All together 38 facilitators were trained. After the training teachers became country coordinators. Their role is to support the facilitators during the intervention by e.g. organizing supervisions. The teleconferences of the country coordinators (mostly former teachers) are being continued.

To monitor the performance the Competency TO-DO Checklists were developed to follow the audio-taped facilitators’ ACP with patients precisely. A Facilitators’ Competency Evaluation Manual to instruct evaluators was provided by WP3 team. By analyzing the reports WP3 team will be able to establish a simplified evaluation tool for the ACP facilitators’ performance. This will serve for further development of the quality indicators and valid fidelity criteria by identification of the critical ingredients of the intervention, and enable the development of process rating scales for their measurement for later check during the study.

Jun 2015 – Nov 2016:
In this period WP3 organized and coordinated midterm monitoring of the performance of the facilitators in conducting ACP according to the Respecting Choices program.

By identifying critical elements of the Respecting Choices intervention valid fidelity criteria were established with cooperation of the authors of the Respecting Choices model. Three different fidelity check lists were created for three specific situations in ACTION intervention.

To support standardized fidelity assessments, firstly a brief training was organized through teleconference for evaluators in all countries in January 2016. An English audio-tape of ACP conversation was sent to each of them in advance. They assessed this test conversation and sent the reports to WP3 before our teleconference. Differences in the fidelity assessments were discussed and agreements of standardized approaches achieved.

A Fidelity Assessment Manual was provided for instructions about using the Fidelity Checklists while listening to audiotapes and a common Report template was developed to summarize fidelity assessments.

The midterm fidelity assessment was performed during Summer 2016 in all countries and results were reported during the consortium meeting in Copenhagen by WP3. Next fidelity assessment of all facilitators is planned for June 2017, at the end of the patient inclusion period.

WP3 conducted regular teleconferences for coordinators and teachers in order to exchange information and experiences, and to monitor the process of ACP conversations in all countries.


Dec 2013 – May 2015:
Version 1.0 of the protocol has been ethically approved by all countries involved in the project and all the necessary ethical and regulatory approvals are in place. Background hospital reports for each site have been produced along with country reports for each ACTION partner. The project website, is up and running. The International Standard Randomised Controlled Trial Number (ISRCTN) is 17231.

Jun 2015 – Nov 2016:
WP4 has maintained the ACTION website and has contributed to the work streams of other work packages during this period. They have collected the necessary data for the DSMB, attended steering committee meetings as well as the consortium meeting in Copenhagen in October 2016 (WP1). They have been involved in the recruitment of participants, carried out data collection, carried out the Respecting Choices intervention and inputted data into Gemstracker (WP5). The Respecting Choices facilitator has been involved in the monitoring process overseen by WP 3 and has taken part in a qualitative focus group organised by WP 8. WP4 produced a hospital newsletter for the project and as well as a blog for the EAPC website (WP9).


Dec 2014 – Nov 2015:
In preparation of the pilot testing of the intervention, the questionnaires that were used to measure process and outcome measures were implemented in GemsTracker, a multi-language web-based platform for collecting and analyzing data. A specific user guide for entering study data during the pilot testing was developed, including procedures to protect the confidentiality of the database. Data collected during the pilot testing were entered using GemsTracker. Systematic evaluation of the use of GemsTracker during the feasibility study showed that its use was feasible for ACTION.

A standardized data extraction form for the review of patients’ hospital medical records (and corresponding instructions on how to use the data extraction form) was developed. This provisional data extraction form and corresponding instructions is currently being pilot tested in all participating hospitals. The results of the pilot testing are expected by the end of August 2015.
With the enrolment of the first patients in the study in month 18, data collection has started.

Dec 2015 – Nov 2016:
GemsTracker is being used in all countries to collect quantitative data of study participants. Adaptations to the system are made if needed (e.g. implementation of additional forms or questionnaires, solving problems or software bugs). Overviews are made on a regular basis in order to monitor and report on the status of data collection.

After the pilot study of the data extraction form for the review of patients' hospital medical records, the form was adapted where necessary (e.g. instructions were improved, wording and structure were refined, answering options were added). The final form consists of 30 items regarding survival, date and place of death, presence and content of advance directives, assignment of a proxy decision-maker, physician orders for treatment, diagnostic procedures and treatment received, hospitalisations, and specialist palliative care. The form is currently being used in all participating hospitals, and has been implemented in GemsTracker.
Inclusion has started and is being closely monitored in all participating hospitals.


Jun 2015 – Nov 2016:
Documentation for the qualitative study, including the protocol, participant documents, and interview and focus group topic guides was developed collaboratively by teams from Italy, the Netherlands and the UK. All ethical and research governance approvals required for the qualitative study have been obtained.

Facilitator Focus Groups
Seven focus groups involving 29 facilitators from the 6 participating countries have been completed. The purpose of these discussions was to explore facilitators’ perceptions and experiences of delivering the Respecting Choices intervention. Focus group discussions have been transcribed and translated into English. Data analysis is progressing as a collaborative process between the three countries which will participate fully in the qualitative study, namely Italy, Netherlands and the UK. UK and Netherlands plan to conduct follow up focus groups to explore facilitators’ reflections on the Respecting Choices intervention from the perspective of experience gained towards the end of the project.

Patient Case Studies
Up to ten patient case studies will be developed in each participating country (UK, Italy and Netherlands) involving patients, their personal representatives and nominated healthcare professionals. Baseline and follow up interviews will be carried out with patient and personal representatives and a single interview with nominated healthcare professionals. Should the patient die before follow up, an interview will be sought with their bereaved personal representative. The purpose of the interviews is to explore participants’ experiences of the Respecting Choices intervention and how they have engaged with Advance Care Planning during the period of their involvement in the study. Transcripts of recorded Respecting Choices interventions will be included in the data set and analysis of each case study.

Recruitment to the qualitative study is now getting underway as planned, having been scheduled to start from summer 2016 once the recruitment to the ACTION trial was well established. It has been agreed that recruitment to the qualitative study will proceed slowly and incrementally in order to avoid interruption of recruitment to the trial.

The data set for the first UK patient case is nearly complete and Italy has recruited their first patient. The Netherlands has recently received ethical approval for the qualitative study and will start recruitment shortly.

WP9/Erasmus MC:

Dec 2013 – May 2015:
A stakeholder list and a dissemination plan have been developed. The first newsletter will be send to the stakeholders in September 2015.

Jun 2015 – Nov 2016:
We distributed the first newsletter to the stakeholders and monitored the development of another newsletter for the hospital sites. We are actively using twitter and currently have over 300 followers. We presented the design of the ACTION study in several national and international conferences, such as the ACPEL conference 2015 in Munich and the EAPC conference 2016 in Dublin.

Potential Impact:
This project aims to improve comfort and quality of life of cancer patients and cancer survivors, and more in general to improved health of European citizens. A formalized and promising ACP program (the Respecting Choices program) is going to be assessed. The effect of this ACP program on patients’ comfort and quality of life is possibly going to be accomplished through:
1. The empowerment of patients with advanced cancer to efficiently express and discuss their preferences for care, both in the contexts of medical consultations as well as with relatives.
2. The improvement of patient-physician communication.
3. The facilitation of delivery of care that is in accordance with the patients’ wishes.

If this project will indeed demonstrate that ACP positively affects cancer patients’ comfort and quality of life, the combination of these beneficial effects and a favourable cost-effectiveness balance makes ACP an important intervention for cancer patients, their relatives, health care professionals and policy makers. ACP will meaningfully contribute to the development of personalized, integrated care for patients with advanced cancer and will facilitate coordination among health care professionals. In addition, ACP may have the potential to reduce unnecessary use of health care resources.

Through studying common types of cancer the relevance of our findings is enhanced. By studying different cancers we increase the generalizability of our findings. The results of the ACTION project have high potential to be transferable to other diseases. Taken together with the fact that our study takes a culturally sensitive perspective, the impact of our project in principle extends to the majority of patients in Europe who are in the last stages of life.

Besides contributing to quality of care and quality-of-life, this project aims to contribute to sustainable and efficient healthcare systems. One of the novel aspects of this project concerns the cost-effectiveness analysis of ACP. We expect that the introduction of ACP programs also has the potential to have an economic impact on health care costs for all EU countries. While we would like to stress that this is not the key aim of ACP, it may be a substantial and very favourable effect, which could facilitate the uptake of the program and lower potential financial barriers.

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