Complementary and Alternative Medicine Among Patients With Hematologic Malignancies in France (COMPLHEMATO)

April 16, 2026 updated by: University Hospital, Limoges

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Limoges, France, 87042
      • Pau, France, 64000
        • CH PAU
        • Contact:
        • Principal Investigator:
          • Maï Renault-Fradin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hematological malignancies (leukemia, lymphoma or myeloma)
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of the study, 18 months after the first inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of use for each identified CAM
Time Frame: At the end of the study, 18 months after the first inclusion
The frequency of use for each specific CAM therapy identified in our sample will be calculated.
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
Themes will be derived from the content analysis of semi-structured interviews conducted with patients.
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

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).
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
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.
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
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.
At the end of the study, 18 months after the first inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Jean Toniolo, University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI25_0015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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