NCT07541326

Brief 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). 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Jun 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

March 30, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

Alternative medicinecomplementary medicineblood disease

Outcome Measures

Primary Outcomes (1)

  • 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

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

Secondary Outcomes (5)

  • Percentage of use for each identified CAM

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

  • Themes identified in content analysis:

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

  • Average specific quality of life score

    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

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

  • Results of multivariate logistic regression

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

Study Arms (1)

Hematological malignancies (leukemia, lymphoma or myeloma)

OTHER
Other: Questionnaire on Complementary and Alternative Medicines (CAM)

Interventions

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.

Hematological malignancies (leukemia, lymphoma or myeloma)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Limoges

Limoges, 87042, France

Location

CH PAU

Pau, 64000, France

Location

MeSH Terms

Conditions

Hematologic NeoplasmsHematologic Diseases

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jean Toniolo

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 21, 2026

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations