CancerCAPSNCT05684939
Relation Between Substance Use and Pain, in Patients Suffering or Surviving From Cancer and Followed in France
An observational study of Cancer and Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Pain, Substance Use
- What is being tested?
- Questionnaire (patient reported outcome)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,010 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2023to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients and cancer survivors recruited thanks to associations of cancer patients and social networks
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Cancer, Pain, Substance Use
- Being tested
- Questionnaire (patient reported outcome)
- Medical subject headings
- Neoplasms, Pain, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire (patient reported outcome)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| cancer patients and cancer survivors | answer to an online questionnaire Receives: Behavioral: Questionnaire (patient reported outcome) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (10)
Pain severity
Brief pain inventory
Measured: day 1
Neuropathic pain
DN4 interview questionnaire
Measured: day 1
Analgesic use
Ongoing analgesic drugs
Measured: day 1
Chemotherapy-induced peripheral neuropathy
QLQ-CIPN20 questionnaire
Measured: day 1
Health-related quality of life and symptoms
QLQ-C30 questionnaire
Measured: day 1
Anxiety and depression
HADS questionnaire
Measured: day 1
Material and social deprivation
EPICES questionnaire
Measured: 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
Measured: day 1
Oncological characteristic
type of cancer, date of cancer diagnosis, and type of treatment (received and/or ongoing)
Measured: day 1
Intercurrent pathologies
open question
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start27 Jan 2023
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684939
- Sponsor's protocol ID
- RNI 2022 BALAYSSAC
- Acronym
- CAPS
- Status last verified
- Dec 2022
- First submitted
- 4 Jan 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ragusa C, Pereira B, Balayssac D. Assessment of pain prevalence in cancer patients undergoing anticancer treatments and in cancer survivors after completion of anticancer treatments: A French nationwide cross-sectional study. Int J Cancer. 2025 May 15;156(10):1873-1884. doi: 10.1002/ijc.35280. Epub 2024 Dec 3.
PubMed 39625069Ragusa C, Pereira B, Balayssac D. Study of the relationship between psychoactive substance use and pain in cancer patients and cancer survivors: A French nationwide cross-sectional study. Int J Cancer. 2024 Sep 15;155(6):1078-1090. doi: 10.1002/ijc.35006. Epub 2024 May 15.
PubMed 38747216
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05684939
- Acronym / sponsor ID
- CAPS / RNI 2022 BALAYSSAC
- Conditions
- Cancer, Pain, Substance Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,010 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer patients and cancer survivors | – | Behavioral: Questionnaire (patient reported outcome)answer to an online questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients and cancer survivors recruited thanks to associations of cancer patients and social networks
Key inclusion criteria (1 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | cancer patients and cancer survivors |
Primary outcome
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
10 secondary outcomes
Pain severity
Time frame: day 1
Neuropathic pain
Time frame: day 1
Analgesic use
Time frame: day 1
Chemotherapy-induced peripheral neuropathy
Time frame: day 1
Health-related quality of life and symptoms
Time frame: day 1
Anxiety and depression
Time frame: day 1
Material and social deprivation
Time frame: day 1
Sociodemographic characteristics of patient
Time frame: day 1
Oncological characteristic
Time frame: day 1
Intercurrent pathologies
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Derived from this study: PubMed 39625069Ragusa C, Pereira B, Balayssac D. Assessment of pain prevalence in cancer patients undergoing anticancer treatments and in cancer survivors after completion of anticancer treatments: A French nationwide cross-sectional study. Int J Cancer. 2025 May 15;156(10):1873-1884. doi: 10.1002/ijc.35280. Epub 2024 Dec 3.
- Derived from this study: PubMed 38747216Ragusa C, Pereira B, Balayssac D. Study of the relationship between psychoactive substance use and pain in cancer patients and cancer survivors: A French nationwide cross-sectional study. Int J Cancer. 2024 Sep 15;155(6):1078-1090. doi: 10.1002/ijc.35006. Epub 2024 May 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Pain, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
substance use (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684939, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.