CancerINDICANCT07280416
Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer
An observational study of Cancer and Insomnia, run by Centre Hospitalier Emile Roux at 1 site in France.
Trial summary
The diagnosis of cancer can be a major trigger for new sleep problems, especially insomnia, in people who did not have sleep issues before. Insomnia may appear early in the care pathway and can continue over time, often interacting with other physical or emotional symptoms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2025to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study includes adult patients (≥18 years) with a confirmed diagnosis of metastatic or non-metastatic cancer, who are scheduled to receive intravenous chemotherapy and/or immunotherapy (intravenous or subcutaneous). Eligible participants must be able to read and understand French, be covered by a social security system, and provide signed informed consent. Patients must not have pre-existing sleep disorders (SCI score ≥16) and must not have severe cognitive or major psychiatric disorders that could interfere with participation. Patients in emergency situations or under legal protection measures unable to consent are excluded.
Who may be able to join
- Confirmed diagnosis of metastatic or non-metastatic cancer,
- Cancer treated with intravenous chemotherapy and/or immunotherapy administered intravenously or subcutaneously,
- Age ≥ 18 years,
- Ability to read and understand French,
- Patient covered by a social security system,
- Signed informed consent.
Who cannot join
- SCI questionnaire score <16
- Diagnosed or controlled sleep disorders
- Presence of severe cognitive disorders (e.g., Alzheimer's disease) or major psychiatric disorders (e.g., psychosis), as noted in the medical record, observed at recruitment, or reported by the patient
- Patient in an emergency situation, or subject to a legal protection measure (guardianship, curatorship, or judicial protection) and unable to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
12 boulevard du Dr Chantemesse
Le Puy-en-Velay, 43000
About this study
Official title: Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.
The diagnosis of cancer can be a major trigger for new sleep problems, especially insomnia, in people who did not have sleep issues before. Insomnia may appear early in the care pathway and can continue over time, often interacting with other physical or emotional symptoms.
The main goal of this preliminary study is to describe how insomnia develops during the first months after a cancer diagnosis in patients who had no sleep problems at the time of diagnosis. This will be done through regular follow-up over time.
Read more
A secondary aim is to identify the factors that may contribute to the onset or persistence of insomnia, such as the cancer treatments patients receive, as well as any medical or non-medical therapies used to manage sleep difficulties.
The study will also look at whether patients who develop sleep problems are referred to psychologists trained in specific therapies for insomnia, and how well they follow and adhere to these treatments.
- Conditions
- Cancer, Insomnia, Pain, Depression Anxiety Disorder, Quality of Life
- Keywords
- cancer, insomnia, pain, Depresion Anxiety disorder, longitudinal
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have just been diagnosed with cancer. | These patients will be followed up with for one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer
The primary objective of this longitudinal study is to diagnose insomnia and track its evolution and severity in patients newly diagnosed with cancer over the first year after diagnosis. Two validated questionnaires will be repeatedly administered: the Sleep Condition Indicator (SCI) and the Insomnia Severity Index (ISI). The SCI, based on DSM-5 criteria, identifies probable clinical insomnia by assessing symptom frequency, duration (difficulty falling asleep, night awakenings, early awakening), and functional impact. The ISI is a 7-item questionnaire evaluating perceived sleep difficulties over the past two weeks, including sleep initiation, maintenance, early awakening, daytime functioning, and distress. Total scores classify insomnia as absent, subclinical, moderate, or severe.
Measured: over a 12-month period
Secondary outcomes (3)
The secondary objective is to characterize Pain perception and the impact of pain on the patient's daily behaviour
Pain perception and the impact of pain on the patient's daily behaviour will be assessed using the Concise Pain Questionnaire (QCD), the French version of the Brief Pain Inventory (BPI). This validated questionnaire assesses the impact of pain on seven general aspects of the patient's life (activity, mood, walking ability, work, relationships, sleep and enjoyment of life) (32, 33),
Measured: over a 12-month period
The secondary objective is to characterize the patient's levels of anxiety and depression
The patient's levels of anxiety and depression will be assessed using the validated Hospital Anxiety and Depression Scale (HADS). For each component (anxiety, depression), the score obtained is analysed: a score of 7 or below indicates an absence of symptoms, a score between 8 and 10 indicates uncertain symptoms, and a score of 11 or above indicates definite symptoms (34),
- All treatments used to combat insomnia will be recorded,
- The percentage of completed questionnaires will be calculated.
Measured: over a 12-month period
The secondary objective is to characterize cancer-related anxiety/depression in patients newly diagnosed with cancer.
Patient anxiety and depression will be assessed using the validated Hospital Anxiety and Depression Scale (HADS). Each subscale (anxiety and depression) is scored separately: ≤7 indicates no symptoms, 8-10 suggests borderline symptoms, and ≥11 reflects definite symptoms.
Measured: over 12-months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start16 Dec 2025
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Emile Roux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280416
- Sponsor's protocol ID
- RIPH2_PANTE_INDICA
- Other IDs
- ID-RCB
- Acronym
- INDICA
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer: a Longitudinal Study and Analysis of Associated Factors.
- ClinicalTrials.gov ID
- NCT07280416
- Acronym / sponsor ID
- INDICA / RIPH2_PANTE_INDICA
- Conditions
- Cancer, Insomnia, Pain, Depression Anxiety Disorder, Quality of Life
- Keywords
- cancer, insomnia, pain, Depresion Anxiety disorder, longitudinal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Centre Hospitalier Emile RouxUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 12 Dec 2025 (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.
The diagnosis of cancer can be a major trigger for new sleep problems, especially insomnia, in people who did not have sleep issues before. Insomnia may appear early in the care pathway and can continue over time, often interacting with other physical or emotional symptoms.
The main goal of this preliminary study is to describe how insomnia develops during the first months after a cancer diagnosis in patients who had no sleep problems at the time of diagnosis. This will be done through regular follow-up over time.
A secondary aim is to identify the factors that may contribute to the onset or persistence of insomnia, such as the cancer treatments patients receive, as well as any medical or non-medical therapies used to manage sleep difficulties.
The study will also look at whether patients who develop sleep problems are referred to psychologists trained in specific therapies for insomnia, and how well they follow and adhere to these treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have just been diagnosed with cancer. | – | –These patients will be followed up with for one year. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes adult patients (≥18 years) with a confirmed diagnosis of metastatic or non-metastatic cancer, who are scheduled to receive intravenous chemotherapy and/or immunotherapy (intravenous or subcutaneous). Eligible participants must be able to read and understand French, be covered by a social security system, and provide signed informed consent. Patients must not have pre-existing sleep disorders (SCI score ≥16) and must not have severe cognitive or major psychiatric disorders that could interfere with participation. Patients in emergency situations or under legal protection measures unable to consent are excluded.
Key inclusion criteria (6 listed)
- Confirmed diagnosis of metastatic or non-metastatic cancer,
- Cancer treated with intravenous chemotherapy and/or immunotherapy administered intravenously or subcutaneously,
- Age ≥ 18 years,
- Ability to read and understand French,
- Patient covered by a social security system,
Key exclusion criteria (4 listed)
- SCI questionnaire score <16
- Diagnosed or controlled sleep disorders
- Presence of severe cognitive disorders (e.g., Alzheimer's disease) or major psychiatric disorders (e.g., psychosis), as noted in the medical record, observed at recruitment, or reported by the patient
- Patient in an emergency situation, or subject to a legal protection measure (guardianship, curatorship, or judicial protection) and unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer
Time frame: over a 12-month period
The primary objective of this longitudinal study is to diagnose insomnia and track its evolution and severity in patients newly diagnosed with cancer over the first year after diagnosis. Two validated questionnaires will be repeatedly administered: the Sleep Condition Indicator (SCI) and the Insomnia Severity Index (ISI). The SCI, based on DSM-5 criteria, identifies probable clinical insomnia by assessing symptom frequency, duration (difficulty falling asleep, night awakenings, early awakening), and functional impact. The ISI is a 7-item questionnaire evaluating perceived sleep difficulties over the past two weeks, including sleep initiation, maintenance, early awakening, daytime functioning, and distress. Total scores classify insomnia as absent, subclinical, moderate, or severe.
3 secondary outcomes
The secondary objective is to characterize Pain perception and the impact of pain on the patient's daily behaviour
Time frame: over a 12-month period
The secondary objective is to characterize the patient's levels of anxiety and depression
Time frame: over a 12-month period
The secondary objective is to characterize cancer-related anxiety/depression in patients newly diagnosed with cancer.
Time frame: over 12-months period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Insomnia, run by Centre Hospitalier Emile Roux 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 6 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie GADEA, PhD (+33 471 043 538, science.writer@ch-lepuy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer (time frame: over a 12-month period). 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 26 Oct 2026.