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NCT Number: NCT04172818

Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families

Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft versus host reaction. The protective isolation is also a source of physical and psychological isolation. Published studies reported depressive syndrome, anxiety symptoms and post-traumatic stress disorders for patients and their families. Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma. In analogy, the diary for the patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long terms consequences. The investigators want to evaluate the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.

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Key information

Conditions

Hematopoietic/Lymphoid Cancer Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Mental Disorders Neoplasms Neoplasms by Site Psychological Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient age > 18 years
  • patient hospitalized for an hematopoietic allogenic stem cell transplantation
  • patient agreeing to participate

Exclusion criteria

  • patient not hospitalized for an hematopoietic allogenic stem cell transplantation

Treatment and study plan

Quality of Life Questionnaire

Behavioral

Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma.In analogy, the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. The psychological impact of a diary on patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives will be evaluated.

Primary outcomes

  1. Measure of diary impact on patient quality of life

    Time frame: at day 0

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  2. Measure of diary impact on patient quality of life

    Time frame: through the end of hospitalisation, an average of 3 weeks

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  3. Measure of diary impact on patient quality of life

    Time frame: at 30 days after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  4. Measure of diary impact on patient quality of life

    Time frame: at day 100 after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  5. Measure of diary impact on patient quality of life

    Time frame: 6 months after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  6. Measure of diary impact on patient quality of life

    Time frame: a year after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

Secondary outcomes

  1. Measure of diary impact on health care team satisfaction

    Time frame: at day 0

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  2. Measure of diary impact on health care team satisfaction

    Time frame: through the end of hospitalisation, an average of 3 weeks

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  3. Measure of diary impact on health care team satisfaction

    Time frame: at 30 days after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  4. Measure of diary impact on health care team satisfaction

    Time frame: at day 100 after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  5. Measure of diary impact on health care team satisfaction

    Time frame: 6 months after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  6. Measure of diary impact on health care team satisfaction

    Time frame: a year after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  7. Measure of diary impact on patient relative quality of life

    Time frame: at day 0

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  8. Measure of diary impact on patient relative quality of life

    Time frame: through the end of hospitalisation, an average of 3 weeks

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  9. Measure of diary impact on patient relative quality of life

    Time frame: at 30 days after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  10. Measure of diary impact on patient relative quality of life

    Time frame: at day 100 after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  11. Measure of diary impact on patient relative quality of life

    Time frame: 6 months after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

  12. Measure of diary impact on patient relative quality of life

    Time frame: a year after transplantation

    the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: JACintHE

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Nov 21, 2019
Registry last updated
Mar 22, 2023

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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