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

Lymphoma Clinical Trial

— SPIEVIE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698656
• Other study ID #: RC31/17/0332
• Status: Completed
• Start date: October 10, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Leukemia
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients accepting to enter the study and to complete it on the 6 - 8 month period	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	Rate of entire completion of quality of life scales	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
Secondary	Number of contacted patients with regards to the number of eligible hospitalized patients		6-8 months