- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04412135
The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality (SPIRIHEMATO)
May 29, 2020 updated by: University Hospital, Limoges
The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality During the Initial Healing Phase
The management of patients with malignant hemopathy is based on comprehensive management.
In this context and faced with the various difficulties encountered by cancer patients, the question of spirituality and its experience is central.
Spirituality refers to the person's attachment to what inspires and gives him foundation, as well as the beliefs, values, and existential experiences associated with it, whether these are religious in nature or not.
Although the concept has been identified as a resource in the literature and widely treated in an end-of-life context, assessing the needs of patients with hematological cancer and their loved ones in terms of spirituality from the initiation of treatment does not has not been developed
Study Overview
Study Type
Observational
Enrollment (Anticipated)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jean TONIOLO
- Phone Number: +33 5 55 05 67 55
- Email: jean.toniolo@chu-limoges.fr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
hematologic cancer patient and family member
Description
Inclusion Criteria:
- Aged ≥ 18 years with a recent diagnosis of hematological cancer (lymphoma or leukemia) and in treatment;
- Patients who speak and read French;
- Patients in general condition (physical and mental) judged emotionally and physically fit by the referring nurse to answer the questionnaires;
- Patients benefiting from a social security scheme,
- Patients who signed the non-objection form after being informed of the study,
family person:
- Have been designated by the patient as being the loved one they wish to include with them;
- Aged ≥ 18 years;
- Fluent in and reading French;
- Having signed the non-objection form after being informed of the study.
Exclusion Criteria:
- Patients in recurrence / progress or in remission of cancer;
- Patients in the terminal phase of the disease.
Family person:
person in the curative phase of cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
FACIT-Sp questionnaire
Time Frame: 15 minutes
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2020
Primary Completion (Anticipated)
February 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
May 29, 2020
First Submitted That Met QC Criteria
May 29, 2020
First Posted (Actual)
June 2, 2020
Study Record Updates
Last Update Posted (Actual)
June 2, 2020
Last Update Submitted That Met QC Criteria
May 29, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 87RI19_0050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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