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Completed

NCT Number: NCT05684939

Relation Between Substance Use and Pain, in Patients Suffering or Surviving From Cancer and Followed in France

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire (patient reported outcome)

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Pain severity

    Time frame: day 1

    Brief pain inventory

  2. Neuropathic pain

    Time frame: day 1

    DN4 interview questionnaire

  3. Analgesic use

    Time frame: day 1

    Ongoing analgesic drugs

  4. Chemotherapy-induced peripheral neuropathy

    Time frame: day 1

    QLQ-CIPN20 questionnaire

  5. Health-related quality of life and symptoms

    Time frame: day 1

    QLQ-C30 questionnaire

  6. Anxiety and depression

    Time frame: day 1

    HADS questionnaire

  7. Material and social deprivation

    Time frame: day 1

    EPICES questionnaire

  8. 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

  9. Oncological characteristic

    Time frame: day 1

    type of cancer, date of cancer diagnosis, and type of treatment (received and/or ongoing)

  10. Intercurrent pathologies

    Time frame: day 1

    open question

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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

Acronym: CAPS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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