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: Completed
• Conditions: Pain; Cancer; Substance Use
• Intervention / Treatment: Behavioral: Questionnaire (patient reported outcome)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 2010

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients and cancer survivors recruited thanks to associations of cancer patients and social networks

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cancer patients and cancer survivors; answer to an online questionnaire	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic pain	DN4 interview questionnaire	day 1
Analgesic use	Ongoing analgesic drugs	day 1
Chemotherapy-induced peripheral neuropathy	QLQ-CIPN20 questionnaire	day 1
Health-related quality of life and symptoms	QLQ-C30 questionnaire	day 1
Anxiety and depression	HADS questionnaire	day 1
Material and social deprivation	EPICES questionnaire	day 1
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
Oncological characteristic	type of cancer, date of cancer diagnosis, and type of treatment (received and/or ongoing)	day 1
Intercurrent pathologies	open question	day 1
Pain severity	Brief pain inventory	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2023
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): March 20, 2023

Study Registration Dates

• First Submitted: January 4, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Estimated): June 13, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: RNI 2022 BALAYSSAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No