CancerAPCAM-CLDMNCT05235022
After Cancer in the Military: What Happens After Long-term Sick Leave
An observational study of Cancer, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
In recent decades, early diagnosis and improved treatment have led to increased survival for most people with cancer. This improved survival has led to more attention being paid to the quality of life of these people, and to their reintegration into social and professional life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Questionnaires
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2022to 29 Jul 2022
- 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: The study population will be composed of French military personnel who were placed on long-term sick leave for the management of a tumor pathology between January 2015 and December 2020.
Who may be able to join
- French military personnel who were placed on long-term sick leave for the management of a tumor pathology between January 2015 and December 2020,
- French-speaking.
Who cannot join
- Under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
In recent decades, early diagnosis and improved treatment have led to increased survival for most people with cancer. This improved survival has led to more attention being paid to the quality of life of these people, and to their reintegration into social and professional life. In France, 3.8 million people are treated or in remission from cancer in 2017. Among the 400,000 new patients diagnosed with cancer each year in France, 160,000 (40%) are in professional activity.
Cancer treatments induce after-effects that can be felt several months or even years after the diagnosis and have an impact on life. In a study of patients in remission from cancer at 12 months after diagnosis, 47 to 53% of patients had changed jobs or stopped working. In another Finnish study, 26% of patients had decreased physical ability and 19% had decreased mental ability to work five years after cancer diagnosis.
Read more
In France, studies that have evaluated the impact of cancer on employment and the factors associated with return to work after cancer are still rare: the VICAN study showed that among people in work at the time of diagnosis, 20% were no longer working five years later.
With an estimated annual incidence of approximately 400 new cancers per year, the military population is also affected by cancer. Professional reintegration after cancer is of particular concern to the military. The specificity and requirements of the military condition can indeed make this reintegration more difficult. Regular or even intense physical activity is indeed essential but can be difficult after undergoing anti-cancer treatments. Moreover, external operations and many activities are conditioned by the obtaining of medical skills, which are sometimes incompatible with the state of health of patients recently treated for a neoplastic pathology. The studies previously carried out concerning the professional future after cancer do not seem to us to be transposable to the military population. To our knowledge, no study has evaluated occupational reintegration in military personnel after cancer.
The aim of this study is to evaluate the difficulties encountered during the post-cancer professional reintegration of military personnel in terms of fatigue, aptitude and advancement, in order to anticipate them and possibly remedy them. The identification of these difficulties will eventually allow to anticipate them and possibly to remedy them via an adapted post-cancer professional reintegration pathway.
- Conditions
- Cancer
- Being tested
- Questionnaires
- Keywords
- Long-term sick leave
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
The participants included in the study will have to answer:
- a questionnaire created specifically for the study concerning the possible difficulties encountered during their return to work,
- the Multidimensional Fatigue Inventory (MFI), a questionnaire assessing fatigue through 5 dimensions (general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation).
These 2 questionnaires will be filled during a 30-minute face-to-face or phone interview.
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the difficulties reported by the patients during their return to work after cancer
The primary outcome measure is descriptive. The purpose is to highlight the difficulties most often mentioned by patients during the interview.
Measured: Until the end of the study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start3 Mar 2022
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235022
- Sponsor's protocol ID
- 2021PPRC07
- Other IDs
- 2021-A02180-41
- Acronym
- APCAM-CLDM
- Status last verified
- May 2023
- First submitted
- 25 Jan 2022
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After Cancer in the Military: What Happens After Long-term Sick Leave
- ClinicalTrials.gov ID
- NCT05235022
- Acronym / sponsor ID
- APCAM-CLDM / 2021PPRC07
- Conditions
- Cancer
- Keywords
- Long-term sick leave
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 10 Feb 2022 (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.
In recent decades, early diagnosis and improved treatment have led to increased survival for most people with cancer. This improved survival has led to more attention being paid to the quality of life of these people, and to their reintegration into social and professional life. In France, 3.8 million people are treated or in remission from cancer in 2017. Among the 400,000 new patients diagnosed with cancer each year in France, 160,000 (40%) are in professional activity.
Cancer treatments induce after-effects that can be felt several months or even years after the diagnosis and have an impact on life. In a study of patients in remission from cancer at 12 months after diagnosis, 47 to 53% of patients had changed jobs or stopped working. In another Finnish study, 26% of patients had decreased physical ability and 19% had decreased mental ability to work five years after cancer diagnosis.
In France, studies that have evaluated the impact of cancer on employment and the factors associated with return to work after cancer are still rare: the VICAN study showed that among people in work at the time of diagnosis, 20% were no longer working five years later.
With an estimated annual incidence of approximately 400 new cancers per year, the military population is also affected by cancer. Professional reintegration after cancer is of particular concern to the military. The specificity and requirements of the military condition can indeed make this reintegration more difficult. Regular or even intense physical activity is indeed essential but can be difficult after undergoing anti-cancer treatments. Moreover, external operations and many activities are conditioned by the obtaining of medical skills, which are sometimes incompatible with the state of health of patients recently treated for a neoplastic pathology. The studies previously carried out concerning the professional future after cancer do not seem to us to be transposable to the military population. To our knowledge, no study has evaluated occupational reintegration in military personnel after cancer.
The aim of this study is to evaluate the difficulties encountered during the post-cancer professional reintegration of military personnel in terms of fatigue, aptitude and advancement, in order to anticipate them and possibly remedy them. The identification of these difficulties will eventually allow to anticipate them and possibly to remedy them via an adapted post-cancer professional reintegration pathway.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of French military personnel who were placed on long-term sick leave for the management of a tumor pathology between January 2015 and December 2020.
Key inclusion criteria (2 listed)
- French military personnel who were placed on long-term sick leave for the management of a tumor pathology between January 2015 and December 2020,
- French-speaking.
Key exclusion criteria (1 listed)
- Under 18 years old
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 |
|---|---|---|
| QuestionnairesThe participants included in the study will have to answer: 1. a questionnaire created specifically for the study concerning the possible difficulties encountered during their return to work, 2. the Multidimensional Fatigue Inventory (MFI), a questionnaire assessing fatigue through 5 dimensions (general fatigue, physical fatigue, mental fatigue, reduced activity and reduced motivation). These 2 questionnaires will be filled during a 30-minute face-to-face or phone interview. | Other | – |
Primary outcome
Description of the difficulties reported by the patients during their return to work after cancer
Time frame: Until the end of the study (12 months)
The primary outcome measure is descriptive. The purpose is to highlight the difficulties most often mentioned by patients during the interview.
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 3 May 2023.
- Individual participant dataSharing planned: Undecided
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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, run by Direction Centrale du Service de Santé des Armées 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 2 inclusion and 1 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 3 May 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?
Description of the difficulties reported by the patients during their return to work after cancer (time frame: Until the end of the study (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2023.