NCT05684939

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,010

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

January 27, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

June 13, 2023

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

January 4, 2023

Last Update Submit

June 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Pain severity

    day 1

  • Neuropathic pain

    day 1

  • Analgesic use

    day 1

  • Chemotherapy-induced peripheral neuropathy

    day 1

  • Health-related quality of life and symptoms

    day 1

  • +5 more secondary outcomes

Study Arms (1)

cancer patients and cancer survivors

answer to an online questionnaire

Behavioral: Questionnaire (patient reported outcome)

Interventions

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

cancer patients and cancer survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

NeoplasmsPainSubstance-Related Disorders

Interventions

Surveys and QuestionnairesPatient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthHealth Care SurveysHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 13, 2023

Study Start

January 27, 2023

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

June 13, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations