Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Lung Neoplasms

Death

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Information on chemotherapy as done in routine practice following national and international guidelines

Information on the potential role of anticancer chemotherapy in worsening life-threatening conditions

One of two trained oncologist will meet the patient and inform him following an interview-guideline

Truthful information on chemotherapy risks

Standard of information

Olivier HUILLARD, MD, PhD

Francois GOLDWASSER, MD, PhD

Patients with metastatic cancer have a substantial symptom burden and may receive aggressive care at the end of life. There is evidence that the use of chemotherapy near the end of life is not related to its likelihood of providing benefit and the overuse of aggressive anticancer therapies near the end of life may result in more toxicity than clinical benefit. Moreover, proposing new lines of treatment after successive therapeutic failures may be a way of avoiding discussion of prognosis and advance care planning. It has been proposed that systems not providing overly aggressive care near the end of life would be the ones in which less than 10% of patients receive chemotherapy in the last 14 days of life. Presently the first consultation between patient and oncologist is ruled in France by the first "Plan Cancer" and the "Dispositif d'annonce" (announcement planning). Oncologists are supposed to explain the diagnosis of cancer and to present a treatment plan. In routine practice for metastatic non curable cancer patients, chemotherapy is presented as the leading therapy and its side effects are explained. The use of chemotherapy has been associated with the worsening of two major competitive life-threatening conditions for cancer patients: cachexia and thrombo-embolic events. Nevertheless the risk of worsening both those conditions is hardly explained in routine practice.

This study proposes to examine in a monocentric interventional prospective randomized trial, the impact of a particular way for the oncologist to present chemotherapy at the diagnosis stage on the easiness of timely chemotherapy interruption at the end of life. The main objective is to determine whether or not the explanation of the potential role of anticancer chemotherapy in worsening life-threatening conditions impacts the proportion of patients receiving chemotherapy in the last 30 days of life compared with usual presentation. Secondary objectives are to determine the impact of this communication strategy on overall survival and other indicators of aggressiveness of care and palliative care resources use.

The hypothesis is that the intervention will allow 15% of patients receiving anticancer therapy during the last 30 days of life, as compared to 30% in the control group.

The investigators expect that the intervention evaluated in this study will reduce the rate of patients receiving chemotherapy during the last 30 days of life hopefully improving the quality of end of life care. A secondary objective is overall survival and this study will therefore verify that the intervention arm is not associated with poorer overall survival. But more probably investigators expect patients in the intervention arm to have an improved overall survival mainly link to a decrease in harms due to chemotherapy given near the end of life and to better palliative care. In effect the hypothesis is that showing the life-threatening risks associated with chemotherapy and thus reducing for patients the importance of this treatment will leave room for improved palliative care as shown notably by earlier and more frequent referral to palliative care specialists. If this trial is positive, it will prove the capital role of patient-doctor communication in cancer care and that few differences in communication strategy could improve end of life care and maybe even survival. The impact on the oncology community would be major since the intervention could be easily transposed in all practices at no additional cost. It would also emphasize the importance of communication skills and human relationship in the very technical field of medical oncology.

Truthful Information on Chemotherapy and Its Impact on Chemotherapy at the End of Life

Impact of a Truthful Information Concerning Chemotherapy on Chemotherapy Prescription at the End of Life : a Randomized Controlled Study in Non-curable Lung Cancer Patients

National Cancer Institute, France

Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

Assistance Publique - Hôpitaux de Paris

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

face-to-face interviews with the referent oncologist (or hematologist) and his patient (conducted by a physician and a psychologist respectively) as well as interviews with other partners involved in the situation (care staff and relatives)

interviews

The decision to limit or withdraw specific therapies (DLWT) in patients with advanced cancer is a complex process that is always painful for patients, relatives and professionals. For more than 10 years, shared decision making has been more and more emphasized. However, few data in the literature rely on clinical research. In order to understand their difficulties and issues, this study explores the determinants and modalities of DLWT and analyses the feasibility of different methods for investigating this decision making process.

This study explores the decision-making process for patients with advanced cancer when the question to imit or withdraw specific therapies (DLWT) is raised, with a cross-analysis of physicians and pts points of view.

This study took place in 5 oncology and hematology units : 2 university hospitals, 1 general hospital, 1 cancer center and 1 private hospital. The study included two different approaches: an epidemiological section to identify the prevalence of these situations in different institutions and a qualitative study section exploring factors influencing the decision process. The epidemiological analysis included all hospitalized patients identified with advanced cancer for whom the question of DLWT was raised in a given week or during the two weeks preceding the investigation.

The qualitative analysis was based on interviews with the referent oncologist (or hematologist) and his patient (conducted by a physician and a psychologist respectively) as well as interviews with other partners involved in the situation (care staff and relatives) depending on the center. Researchers also participated in multidisciplinary meetings and monitored changes in the decision over a three month period.

Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies.

Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies : Physicians and Patients Points of View and Interactions.

A thematic analysis induces the creation of a set of themes and concepts clustered by relevance into a tree structure. The thematic tree structure constitutes the dataset of interest.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Truthful Information on Chemotherapy and Its Impact on Chemotherapy at the End of Life	NCT02606149	Stage IV Lung C...	Truthful inform... Standard of inf...	18 Years -	Assistance Publique - Hôpitaux de Paris
Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies.	NCT02841124	Advanced Cancer Ethics	interviews	18 Years -	Centre Hospitalier Universitaire de Besancon
Truthful Information on Chemotherapy and Its Impact on Chemotherapy at the End of Life	NCT02606149	Stage IV Lung C...	Truthful inform... Standard of inf...	18 Years -	Assistance Publique - Hôpitaux de Paris
Decision to Limit or Withdraw Specific Therapies for Advanced Cancer and Hematological Malignancies.	NCT02841124	Advanced Cancer Ethics	interviews	18 Years -	Centre Hospitalier Universitaire de Besancon

Spots Global Cancer Trial Database for ethics

Every month we try and update this database with for ethics cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ethics

Every month we try and update this database with for ethics cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ethics cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.