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Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers. (SPIEVIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03698656
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:
Pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer

Condition or disease Intervention/treatment
Acute Leukemia Lymphoma Behavioral: Spiritual Interview

Detailed Description:

Patients with acute leukaemia or lymphoma will be invited to have three interviews centered on spiritual issues on a six-eight months period.

The intervention consist on 3 intervention interviews conducted at the beginning of the study and approximatively 2 and 4 months later (according to the program of medical care). Quality of life (FACT-G) and spiritual well-being (FACIT-SP12) scales will be completed at the beginning (before the first intervention interview) and at the end of the study (approximately 2 month after the third intervention interview, i.e. 6 to 8 month after the first interview).

This pilot study will assess the proportion of patients who will accept to enter in the study and to complete it.

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers : a Pilot Study
Actual Study Start Date : October 10, 2018
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Behavioral: Spiritual Interview
    Three patient interviews (45 to 60 minutes) will be conducted by the study nurse at the beginning of the study and approximately 2 and 4 month later, according to the program of the medical care. Each interview will be conducted according the active listening method of Carl Rogers.

Outcome Measures
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Primary Outcome Measures :
  1. Rate of patients accepting to enter the study and to complete it on the 6 - 8 month period [ Time Frame: 6-8 months ]
    Number of patients having entered the study with regards to the number of the contacted patients, and number of patients having completed the six-eight month study with regards to the patients having entered the study


Secondary Outcome Measures :
  1. Rate of entire completion of quality of life scales [ Time Frame: 6-8 months ]
    Rate of entire completion of functional assessment of cancer therapy - general and The Functional Assessment of Chronic Illness Therapy Spiritual Well-Being 12 items scales whose values will be used in order to determine the sample size of a further randomised controlled trial

  2. Number of contacted patients with regards to the number of eligible hospitalized patients [ Time Frame: 6-8 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute leukaemia or lymphoma during the first month after diagnosis or after first relapse hospitalised in Toulouse Cancer University Hospital
Criteria

Inclusion Criteria:

  • Patients with acute leukaemia or lymphoma, in the first month of hospitalisation after primary diagnosis or firs relapse
  • More than 17 years old
  • French language
  • Having signed informed consent

Exclusion Criteria:

  • Patients requiring palliative care
  • Important psychic vulnerability or severe psychiatric disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698656


Locations
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France
University Hospital Toulouse
Toulouse, France, 31052
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Valérie FLOUCAUD, IDE University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03698656    
Other Study ID Numbers: RC31/17/0332
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Spiritual dimension
Hematologic cancer
Acute leukemia
 Lymphoma
Nurse interview
Quality of life