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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03245983
Other study ID # 2016-32
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2017
Est. completion date February 19, 2020

Study information

Verified date August 2022
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The general aim of research is to identify and analyze the impact and role of spirituality (as a search for meaning and understanding of the meaning of existence) in the experience of cancer. For this purpose, the main objective of this study is to measure the "existential" component in the trajectory of the disease. It is a question of observing its potential contribution to the improvement of the quality of life of the patients and to define if this variable can be translated into a strategy of adjustment for the patients. This research has a double interest: (a) clinical interest in better managing patients' needs; (B) an interest in research in the field of health by combining a measure of spirituality with other psycho-social variables. The project is a prospective non-randomized mono-centric study by questionnaire and research interview. It is a study that seeks to identify the role of spirituality in the experience of illness (i.e. representations, adjustments, emotional distress) and as a determinant of the quality of life of subjects with cancer pathology. The interviews will be conducted by a psychologist to qualitatively collect the elements of the lived experience of the disease in connection with the spiritual elements of the "quest for meaning" type. The population covered by the project is in and out patients coming to the Department of Medical Oncology and Palliative Care at the CHU de la Timone. The realization of this project will allow investigators to explore the specificity of the existential / spiritual dimensions of patients confronted with cancer, to assess the patients' needs for this type of approach within the hospital, to link the existential component / Spiritual with psycho-social variables


Recruitment information / eligibility

Status Completed
Enrollment 162
Est. completion date February 19, 2020
Est. primary completion date February 19, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - patient undergoing chemotherapy Exclusion Criteria: - patient presenting psychiatric or neurological disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaire and interview
Cancer patients will answer questionnaires and will be interviewed by a pshychologist to assess their spirituality and quality of life toward their disease

Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Descriptive analysis of quality of life in patient cancer Questionnaires(QLQC30) for patients with cancer. 36 months
Primary Descriptive analysis of spirituality role in cancer patient Spirituality Index of Well-Being questionnaire 36 month