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NCT Number: NCT07541326

Complementary and Alternative Medicine Among Patients With Hematologic Malignancies in France

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Limoges, Limoges, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdeslam BEN TALEB

CONTACT

[email protected]

+33555058616

Safirah Akowanou

CONTACT

[email protected]

+33555058755

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

Use of Complementary and Alternative Medicine Among Patients With Hematologic Malignancies in France: a Mixed-methods Study

Acronym: COMPLHEMATO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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