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NCT Number: NCT03698656

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

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

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Key information

Conditions

Acute Leukemia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Toulouse

Toulouse, 31052, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Spiritual Interview

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: SPIEVIE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2018
Registry last updated
Dec 28, 2020

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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