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Completed

NCT Number: NCT02841124

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Besançon, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with advanced cancer
  • Existence of a questioning about DLWT
  • Absence of guide lines

Exclusion criteria

  • Incapacity of the patient to participate to an interview
  • Absence of informed consent

Treatment and study plan

Interviews

Other

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)

Primary outcomes

  1. interviews with physicians, patients and relatives

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Centre Hospitalier Universitaire Saint Antoine, Paris
  • Centre Hospitalier de Colmar
  • Centre de Lutte Contre le Cancer Alexis Vautrin, Vandoeuvre les Nancy
  • Clinique Devron, Dijon

Registry information

Official study title

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

Acronym: WHATELSE

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2016
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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