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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05684939
Other study ID # RNI 2022 BALAYSSAC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 27, 2023
Est. completion date March 20, 2023

Study information

Verified date December 2022
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pain is one of the most prevalent symptoms during and after cancer. Pain can be the consequence of several situations (disease progression, surgery, and anticancer drugs). However, pain can frequently be associated with a substance use disorder (alcohol, tobacco, drugs, and illicit products such as cannabis). The relationship between substance use and pain is known to be complex and interdependent, i.e. pain can reinforce substance use and substance use can promote pain. However, few data in the literature are available on the use of psychoactive substances in relation to pain in the context of cancer (cancer patients and cancer survivors). Moreover, the scientific literature agrees on the fact that these elements are little studied and underestimated in the clinic. The investigators hypothesize that, in cancer patients or cancer survivors, the prevalence of the use of psychoactive substances would be higher in the presence of pain, and would be associated with its intensity and its impact on the quality Health-Related Living (HRQoL). The main objective of this study will be to compare, in an adult population of patients suffering from cancer or having had cancer, the prevalence of the consumption of psychoactive substances in painful patients compared to non-painful patients.


Description:

Patients will answer to an online questionnaire thanks to associations of cancer patients and social networks, in order to explore their substance use and pain status.


Recruitment information / eligibility

Status Completed
Enrollment 2010
Est. completion date March 20, 2023
Est. primary completion date March 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patient, male or female, declaring himself as suffering or having suffered from cancer and recruited as such via appropriate communication systems (patient associations, etc.) Exclusion Criteria: - Difficulty to understand French language - Residence outside France (will be verified by the information from the department at the start of the questionnaire) - Patient close relative - Protected adults

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaire (patient reported outcome)
Online self-administered questionnaire exploring substance use, pain, chemotherapy-induced peripheral neuropathy, health-related quality of life, anxiety, depression, social and material deprivation, patients and oncological charactericitcs, and intercurrent pathologies

Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary substance use Legal: alcohol, tobacco, electronic cigarette, psychotropic drugs (benzodiazepines, z-drugs, and opioids), CBD, and other susbtances Illegal: cannabis, and other drugs
At least once in the past year, at least once in the past month, at least once in the past week, or at least once a day
day 1
Secondary Pain severity Brief pain inventory day 1
Secondary Neuropathic pain DN4 interview questionnaire day 1
Secondary Analgesic use Ongoing analgesic drugs day 1
Secondary Chemotherapy-induced peripheral neuropathy QLQ-CIPN20 questionnaire day 1
Secondary Health-related quality of life and symptoms QLQ-C30 questionnaire day 1
Secondary Anxiety and depression HADS questionnaire day 1
Secondary Material and social deprivation EPICES questionnaire day 1
Secondary Sociodemographic characteristics of patient age, sex, height, weight, body mass index, area of residence (urban or rural), socio-professional status (INSEE), and department day 1
Secondary Oncological characteristic type of cancer, date of cancer diagnosis, and type of treatment (received and/or ongoing) day 1
Secondary Intercurrent pathologies open question day 1
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