Hematological MalignanciesCOMPLHEMATONCT07541326
Complementary and Alternative Medicine Among Patients With Hematologic Malignancies in France
A study testing Questionnaire on Complementary and Alternative Medicines (CAM) in people with Hematological Malignancies, run by University Hospital, Limoges at 2 sites in France.
Trial summary
Integrative medicine promotes the incorporation of elements from complementary and alternative medicines (CAM) into patient care. These approaches are defined as treatments that are not routinely part of conventional medical care (1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Questionnaire on Complementary and Alternative Medicines (CAM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jun 2026to 15 Dec 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with acute leukemia, lymphoma, or myeloma who are hospitalized and undergoing treatment at any of the study centers, regardless of the stage of the disease.
- Patients aged 18 years or older.
- Patients who are literate in French.
- Patients who have been informed about the study and have provided their consent to participate.
- Patients covered by health insurance.
Who cannot join
- Patients with neurocognitive disorders or severe psychiatric conditions.
- Patients in the terminal stage of the disease.
- Patients under legal protection measures, such as guardianship or curatorship.
- Patients participating in an interventional study on the effectiveness of CAM.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHU Limoges
Limoges, 87042
Jean Toniolo, +33555058799, jean.toniolo@chu-limoges.fr
Jean Toniolo
CH PAU
Pau, 64000
Maï Renault-Fradin, +33559924912, mai.fradin@ch-pau.fr
Maï Renault-Fradin
About this study
Official title: Use of Complementary and Alternative Medicine Among Patients With Hematologic Malignancies in France: a Mixed-methods Study
Integrative medicine promotes the incorporation of elements from complementary and alternative medicines (CAM) into patient care. These approaches are defined as treatments that are not routinely part of conventional medical care (1). CAM practices include osteopathy, acupuncture, aromatherapy, naturopathy, and various energy-based techniques, although their efficacy is not always well-established. Nevertheless, a meta-analysis on the use of CAM in the context of cancer reported a 40% prevalence of use in 2012 (2). Subsequently, a study conducted in France in 2015 revealed an 83% prevalence of CAM use across all types of cancer, underscoring the interest in these therapies (3). CAM is often employed to alleviate side effects of conventional treatments, such as fatigue, nausea, and vomiting. The 2015 French study primarily focused on solid tumors, with hematological malignancies representing only 2% of the cases, thereby limiting the assessment of CAM use in this context (3). Currently, there is no specific data evaluating the use of CAM among patients with hematological malignancies in France.
Hematological malignancies, unlike solid tumors, are characterized by their diffuse nature, making their localization and treatment more challenging for patients to comprehend (4). Additionally, a qualitative study the investigators conducted on the spiritual needs of patients recently diagnosed with hematological malignancies identified CAM as an area of interest. Among the ten patients in the study, seven were using CAM and reported an improvement in their spiritual well-being, which is defined as the ability to integrate the meaning and purpose of life into their health experiences, through relationships with themselves, others, art, nature, or a higher entity. This aspect of CAM utilization was not explored in our previous study on the spiritual needs of patients, particularly in understanding their appeal and the motivations of patients to adopt them.
Therefore, it appears crucial to explore this practice, which is known to be common among healthcare providers. Understanding these complementary care pathways would enable their safety (e.g., avoiding or informing about potential drug interactions) and foster the patient-provider relationship around a topic that is sometimes considered taboo (5). Ultimately, this would contribute to better supporting patients within a holistic care perspective.
- Conditions
- Hematological Malignancies
- Being tested
- Questionnaire on Complementary and Alternative Medicines (CAM)
- Keywords
- Alternative medicine, complementary medicine, blood disease
- Medical subject headings
- Hematologic Neoplasms, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire on Complementary and Alternative Medicines (CAM)Other
This study employs a mixed-methods approach, combining quantitative and qualitative methods within a convergent design.
Quantitative Data:
- Every hospitalized patient will be invited to participate in the quantitative part of the study.
- Sociodemographic and disease-related data will be collected.
- Participants will complete a questionnaire assessing their use of CAM, created based on existing literature. They will also complete the EORTC QLQ-C30 questionnaire to assess their quality of life and the FACIT-SP questionnaire to evaluate their spiritual well-being, both of which are validated tools for this population.
Qualitative Data:
- A convenience sampling method will be employed to ensure diversity in participant profiles and to capture a comprehensive range of perspectives.
- Semi-structured interviews will be conducted with patients, regardless of whether they use CAM, ensuring coverage of each type of pathology.
| Study group | Role | What they receive |
|---|---|---|
| Hematological malignancies (leukemia, lymphoma or myeloma) | Other | Not described Receives: Other: Questionnaire on Complementary and Alternative Medicines (CAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Complementary and alternative Medicine (CAM) use
This will be determined by identifying patients who report engaging in any form of complementary and alternative medicine, as there is no specific questionnaire available to assess this prevalence
Measured: At the end of the study, 18 months after the first inclusion
Secondary outcomes (5)
Percentage of use for each identified CAM
The frequency of use for each specific CAM therapy identified in our sample will be calculated.
Measured: At the end of the study, 18 months after the first inclusion
Themes identified in content analysis:
Themes will be derived from the content analysis of semi-structured interviews conducted with patients.
Measured: At the end of the study, 18 months after the first inclusion
Average specific quality of life score
The mean score from the European Oraganisation for Research and Treament of Cancer quality of Life Questionnaire Core 30 (EORTC QLQ-C30) questionnaire, validated within our population, will be reported to assess the quality of life of cancer patients. Scores are linearly transformed to a 0-100 scale.
For the functional scales and the global health status/quality of life scale, higher scores indicate a better level of functioning or quality of life.
In contrast, for the symptom scales/items, higher scores indicate a higher level of symptoms (i.e., worse condition).
Measured: At the end of the study, 18 months after the first inclusion
Average score from the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) questionnaire
The mean score from the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) questionnaire, validated in our population, will be used to assess the spiritual well-being of patients. The total score of FACIT-Sp ranges from 0 to 156. The higher score indicates a higher level ofspiritual well-being.
Measured: At the end of the study, 18 months after the first inclusion
Results of multivariate logistic regression
The outcomes will include factors associated with CAM use, with variables such as age, gender, spiritual well-being score, and quality of life score being analyzed.
Measured: At the end of the study, 18 months after the first inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Toniolo, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541326
- Sponsor's protocol ID
- 87RI25_0015
- Acronym
- COMPLHEMATO
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 21 Apr 2026
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Complementary and Alternative Medicine Among Patients With Hematologic Malignancies in France: a Mixed-methods Study
- ClinicalTrials.gov ID
- NCT07541326
- Acronym / sponsor ID
- COMPLHEMATO / 87RI25_0015
- Conditions
- Hematological Malignancies
- Keywords
- Alternative medicine, complementary medicine, blood disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 21 Apr 2026 (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.
Integrative medicine promotes the incorporation of elements from complementary and alternative medicines (CAM) into patient care. These approaches are defined as treatments that are not routinely part of conventional medical care (1). CAM practices include osteopathy, acupuncture, aromatherapy, naturopathy, and various energy-based techniques, although their efficacy is not always well-established. Nevertheless, a meta-analysis on the use of CAM in the context of cancer reported a 40% prevalence of use in 2012 (2). Subsequently, a study conducted in France in 2015 revealed an 83% prevalence of CAM use across all types of cancer, underscoring the interest in these therapies (3). CAM is often employed to alleviate side effects of conventional treatments, such as fatigue, nausea, and vomiting. The 2015 French study primarily focused on solid tumors, with hematological malignancies representing only 2% of the cases, thereby limiting the assessment of CAM use in this context (3). Currently, there is no specific data evaluating the use of CAM among patients with hematological malignancies in France.
Hematological malignancies, unlike solid tumors, are characterized by their diffuse nature, making their localization and treatment more challenging for patients to comprehend (4). Additionally, a qualitative study the investigators conducted on the spiritual needs of patients recently diagnosed with hematological malignancies identified CAM as an area of interest. Among the ten patients in the study, seven were using CAM and reported an improvement in their spiritual well-being, which is defined as the ability to integrate the meaning and purpose of life into their health experiences, through relationships with themselves, others, art, nature, or a higher entity. This aspect of CAM utilization was not explored in our previous study on the spiritual needs of patients, particularly in understanding their appeal and the motivations of patients to adopt them.
Therefore, it appears crucial to explore this practice, which is known to be common among healthcare providers. Understanding these complementary care pathways would enable their safety (e.g., avoiding or informing about potential drug interactions) and foster the patient-provider relationship around a topic that is sometimes considered taboo (5). Ultimately, this would contribute to better supporting patients within a holistic care perspective.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hematological malignancies (leukemia, lymphoma or myeloma) | Other | Other: Questionnaire on Complementary and Alternative Medicines (CAM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with acute leukemia, lymphoma, or myeloma who are hospitalized and undergoing treatment at any of the study centers, regardless of the stage of the disease.
- Patients aged 18 years or older.
- Patients who are literate in French.
- Patients who have been informed about the study and have provided their consent to participate.
- Patients covered by health insurance.
Key exclusion criteria (4 listed)
- Patients with neurocognitive disorders or severe psychiatric conditions.
- Patients in the terminal stage of the disease.
- Patients under legal protection measures, such as guardianship or curatorship.
- Patients participating in an interventional study on the effectiveness of CAM.
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 on Complementary and Alternative Medicines (CAM)This study employs a mixed-methods approach, combining quantitative and qualitative methods within a convergent design. Quantitative Data: * Every hospitalized patient will be invited to participate in the quantitative part of the study. * Sociodemographic and disease-related data will be collected. * Participants will complete a questionnaire assessing their use of CAM, created based on existing literature. They will also complete the EORTC QLQ-C30 questionnaire to assess their quality of life and the FACIT-SP questionnaire to evaluate their spiritual well-being, both of which are validated tools for this population. Qualitative Data: * A convenience sampling method will be employed to ensure diversity in participant profiles and to capture a comprehensive range of perspectives. * Semi-structured interviews will be conducted with patients, regardless of whether they use CAM, ensuring coverage of each type of pathology. | Other | Hematological malignancies (leukemia, lymphoma or myeloma) |
Primary outcome
Proportion of Complementary and alternative Medicine (CAM) use
Time frame: At the end of the study, 18 months after the first inclusion
This will be determined by identifying patients who report engaging in any form of complementary and alternative medicine, as there is no specific questionnaire available to assess this prevalence
5 secondary outcomes
Percentage of use for each identified CAM
Time frame: At the end of the study, 18 months after the first inclusion
Themes identified in content analysis:
Time frame: At the end of the study, 18 months after the first inclusion
Average specific quality of life score
Time frame: At the end of the study, 18 months after the first inclusion
Average score from the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) questionnaire
Time frame: At the end of the study, 18 months after the first inclusion
Results of multivariate logistic regression
Time frame: At the end of the study, 18 months after the first inclusion
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 21 Apr 2026.
- 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.
Jean Toniolo principal investigator
University Hospital, Limoges
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire on Complementary and Alternative Medicines (CAM) in people with Hematological Malignancies, run by University Hospital, Limoges at 2 sites 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 5 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: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Safirah Akowanou (+33555058755, safirah.akowanou@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Complementary and alternative Medicine (CAM) use (time frame: At the end of the study, 18 months after the first inclusion). 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 21 Apr 2026.