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

December 24, 2020 updated by: University Hospital, Toulouse

Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers : a Pilot Study

Pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Toulouse, France, 31052
    - University Hospital toulouse

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

Genders Eligible for Study

All

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

Description

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

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	Measure Description	Time Frame
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	6-8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6-8 months
Number of contacted patients with regards to the number of eligible hospitalized patients Time Frame: 6-8 months		6-8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

Principal Investigator: Valérie FLOUCAUD, IDE, University Hospital, Toulouse

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 (ACTUAL)

October 10, 2018

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

October 1, 2020

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (ACTUAL)

October 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 28, 2020

Last Update Submitted That Met QC Criteria

December 24, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

RC31/17/0332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.