- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684939
Relation Between Substance Use and Pain, in Patients Suffering or Surviving From Cancer and Followed in France (CAPS)
Study of the Relation Between the Consumption of Psychoactive Substances and Pain, in Patients Suffering or Surviving From Cancer and Followed in France: Cross-sectional Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France
- CHU Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cancer patients and cancer survivors
answer to an online questionnaire
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
substance use
Time Frame: day 1
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuropathic pain
Time Frame: day 1
|
DN4 interview questionnaire
|
day 1
|
|
Analgesic use
Time Frame: day 1
|
Ongoing analgesic drugs
|
day 1
|
|
Chemotherapy-induced peripheral neuropathy
Time Frame: day 1
|
QLQ-CIPN20 questionnaire
|
day 1
|
|
Health-related quality of life and symptoms
Time Frame: day 1
|
QLQ-C30 questionnaire
|
day 1
|
|
Anxiety and depression
Time Frame: day 1
|
HADS questionnaire
|
day 1
|
|
Material and social deprivation
Time Frame: day 1
|
EPICES questionnaire
|
day 1
|
|
Sociodemographic characteristics of patient
Time Frame: day 1
|
age, sex, height, weight, body mass index, area of residence (urban or rural), socio-professional status (INSEE), and department
|
day 1
|
|
Oncological characteristic
Time Frame: day 1
|
type of cancer, date of cancer diagnosis, and type of treatment (received and/or ongoing)
|
day 1
|
|
Intercurrent pathologies
Time Frame: day 1
|
open question
|
day 1
|
|
Pain severity
Time Frame: day 1
|
Brief pain inventory
|
day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI 2022 BALAYSSAC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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