NCT03245983

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2020

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

August 8, 2017

Last Update Submit

August 8, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Descriptive analysis of quality of life in patient cancer

    Questionnaires(QLQC30) for patients with cancer.

    36 months

  • Descriptive analysis of spirituality role in cancer patient

    Spirituality Index of Well-Being questionnaire

    36 month

Study Arms (1)

Patient willing to participate

EXPERIMENTAL
Behavioral: Questionnaire and interview

Interventions

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

Patient willing to participate

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient undergoing chemotherapy

You may not qualify if:

  • patient presenting psychiatric or neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and QuestionnairesInterviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Urielle DESALBRES

    Assistance Publique -Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 10, 2017

Study Start

February 6, 2017

Primary Completion

February 19, 2020

Study Completion

February 19, 2020

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations