Holistic Evaluation of Approaches to Long-term Health & Survivorship

NCT07745205 | Active Not Recruiting

• 1 other identifier: HUB2025456
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at investigating behaviors of cancer patient regarding complementary and alternative medicine (CAM) with mixed methodology. The investigators want to realize a pilot study evaluating patient's use and attitude with particular focus on natural products (phyto- and aromatherapy). They aim at giving an overview of their actual consumption (and not to promote natural products) in order to (1) prioritize needs regarding integrative care to promote quality of life and survivorship; (2) identify potential short- or medium-term safety issues for patients; and (3) propose adequate pharmaceutical council. Studied period (years): 2026, approximately 9 months

• Date of first enrolment: to be determined
• Date of last completed: to be determined Objectives: The study has three complementary objectives: Primary objective (quantitative): To descriptively quantify the use of complementary and alternative medicine (CAM) among cancer patients treated at Institut Jules Bordet and to identify patient-reported needs and information sources. Secondary objective (interventional mixed-methods) : To explore patient behaviors, perceptions and expectations regarding CAM use through questionnaires and semi-structured focus groups, including perceptions related to treatment adherence and survivorship experience. In addition, a structured medication review will be conducted for all participants in the focus group phase in order to identify and describe drug-related problems, including potential interactions between conventional treatments and herbal products. Operational objective : To support the prioritization and development of integrative oncology and survivorship programs within the ONCO.CARE and CAIROS projects. Hypotheses: No formal hypothesis testing is planned. This is an exploratory, descriptive study. Study Design (Treatment Schema): Prospective, single-center, two-phase study:
• Phase 1: anonymous quantitative study based on a self-administered questionnaire collecting, among other variables, health-related patient-reported data, including information on cancer type, treatments and symptoms
• Phase 2: Interventional, non-medicinal mixed-methods phase including descriptive questionnaires (pre- and post-session) and semi-structured focus group discussions. Number of patients (planned and analysed): Phase 1 (quantitative survey) :
• Planned: minimum 500 patients;
• Analysed: all completed questionnaires. Phase 2 (interventional mixed-methods) :
• Planned: 30-60 participants (6-8 focus groups, 5-10 participants per group) ;
• Analysed: all participants who attend a focus group session. Endpoints : Primary :
• Descriptive quantification of CAM use among cancer patients ;
• Identification of unmet needs regarding CAM information and guidance. Secondary :
• Descriptive documentation of patient-reported perceptions and experiences related to CAM use and survivorship ;
• Descriptive assessment of the perceived usefulness and acceptability of the focus group sessions.
• Descriptive analysis of the number and type of drug-related problems identified through medication review (PCNE classification, version 9.1) Exploratory : Identification of areas of interest for future research and institutional initiatives related to CAM and integrative oncology. Diagnosis : All cancer types. Main criteria for inclusion (inclusion/exclusion criteria) Inclusion criteria :
• Phase 1 : French-speaking cancer patients entering the Bordet Institute ;
• Phase 2 : French-speaking adult cancer survivor patients who have completed active cancer treatment (in remission or undergoing long-term oral therapy). Exclusion criteria :
• Phase 1 : Individuals without a cancer diagnosis; participants who have already completed the survey ;
• Phase 2 : Patients currently undergoing active cancer treatment. Duration of treatment : Not applicable (no treatment administered) Statistical Considerations:
• Quantitative data will be analyzed using descriptive statistics to summarize socio-demographic characteristics, CAM usage patterns and unmet needs.
• Pre- and post-focus group questionnaires will be analyzed descriptively and separately, without paired or comparative analyses.
• Drug-related problems will be analyzed descriptively according to number and type (PCNE classification, version 9.1).
• Qualitative data from focus groups will be analyzed using rapid qualitative analysis methods to identify key themes, facilitators and barriers related to CAM use and integrative care.

Conditions

Adult Cancer Survivors; Adult Cancer Patients

Keywords

Cancer; survivorship; phytotherapy; holistic health; integrative oncology; CAM; complementary and alternative medicine; natural products; aromatherapy; patient safety; empowerment

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Reporting Use of Complementary and Alternative Medicine as Assessed by the HEALTHS Quantitative Questionnaire

  The percentage of participants who report currently or previously using at least one complementary and alternative medicine (CAM) approach will be calculated from responses to the study-specific HEALTHS quantitative questionnaire. CAM includes complementary practices, natural health products, herbal products, dietary supplements, phytotherapy, aromatherapy, and other complementary approaches included in the questionnaire. The numerator will be the number of participants reporting use of at least one CAM approach. The denominator will be the number of participants who complete the relevant questionnaire item. Results may also be reported by CAM category, cancer type, cancer stage, treatment type, time since diagnosis, province of residence, and self-reported sociodemographic characteristics.

  At completion of the Phase 1 quantitative questionnaire, administered once during the 3-month survey recruitment period The protocol specifies that the Phase 1 questionnaire records CAM use, motivations, perceived benefits and risks, information sources

• Percentage of Participants Reporting Unmet Needs for Information or Professional Guidance About Complementary and Alternative Medicine as Assessed by the HEALTHS Quantitative Questionnaire

  The percentage of participants reporting at least one unmet need related to information, counseling, or professional guidance about complementary and alternative medicine will be calculated using the study-specific HEALTHS quantitative questionnaire. Unmet needs may include insufficient access to reliable CAM information, uncertainty regarding the benefits or risks of CAM, uncertainty regarding interactions with conventional cancer treatments, difficulty identifying qualified professionals, or a desire to discuss CAM with an oncology healthcare professional. The numerator will be the number of participants reporting at least one unmet information or guidance need. The denominator will be the number of participants completing the relevant questionnaire items. Individual unmet-need categories and sources of CAM information will also be summarized as numbers and percentages.

  At completion of the Phase 1 quantitative questionnaire, administered once during the 3-month survey recruitment period The protocol identifies CAM information and guidance needs as a primary endpoint and states that quantitative information on unmet ne

• Percentage of Participants Reporting Adherence to Prescribed Long-Term Oral Anticancer Therapy as Assessed by the HEALTHS Pre-Focus Group Questionnaire

  Among Phase 2 participants receiving long-term oral anticancer therapy, the percentage who report taking their prescribed anticancer treatment in accordance with the prescribed dose and schedule will be summarized using the study-specific HEALTHS pre-focus group questionnaire. The numerator will be the number of eligible participants reporting adherence to their prescribed oral anticancer therapy. The denominator will be the number of Phase 2 participants receiving long-term oral anticancer therapy who complete the relevant adherence item or items. Reported reasons for missed, reduced, delayed, interrupted, or discontinued doses, including reasons associated with CAM use or management of treatment-related symptoms, will be summarized descriptively where collected.

  Immediately before the participant's focus group session The protocol lists treatment adherence alongside conventional oral therapy as a primary endpoint. However, it does not identify a validated adherence scale or provide a scoring method.

Secondary Outcomes (17)

• Distribution of Complementary and Alternative Medicine Approaches and Uses as Assessed by the HEALTHS Quantitative Questionnaire

  At completion of the Phase 1 quantitative questionnaire, administered once during the 3-month survey recruitment period

• Number of Complementary and Alternative Medicine Approaches Used per Participant as Assessed by the HEALTHS Quantitative Questionnaire

  At completion of the Phase 1 quantitative questionnaire, administered once during the 3-month survey recruitment period This needs to remain separate from the percentage of CAM users because its unit is a count of CAM approaches per participant, rather

• Percentage of Participants Reporting Each Motivation for Complementary and Alternative Medicine Use as Assessed by the HEALTHS Quantitative Questionnaire

  At completion of the Phase 1 quantitative questionnaire, administered once during the 3-month survey recruitment period

• Percentage of Participants Reporting Each Source of Information About Complementary and Alternative Medicine as Assessed by the HEALTHS Quantitative Questionnaire

  At completion of the Phase 1 quantitative questionnaire, administered once during the 3-month survey recruitment period

• Percentage of Participants Reporting Perceived Benefits From Complementary and Alternative Medicine as Assessed by the HEALTHS Quantitative Questionnaire

  At completion of the Phase 1 quantitative questionnaire, administered once during the 3-month survey recruitment period

Other Outcomes (1)

• Exploratory and Operational Objectives

  3 months

Study Arms (2)

Phase 1 - quantitative survey : French-speaking cancer patients entering the Bordet Institute

OTHER

Phase 1 - quantitative survey : Minimum 500 patients. A survey will be completed by cancer patients over a three-month period to assess their use of complementary and alternative medicine (CAM). A survey will be made available to cancer patients over a three-month period to assess their use of complementary and alternative medicine (CAM). The questionnaire will be accessible through non-intrusive methods, including dissemination via healthcare professionals, display of study information and QR codes on hospital screens or in waiting areas, and access via a secure online link (REDCap). The survey will be available in both paper format and online via QR code (REDCap). The paper versions of the survey will be collected in a dedicated box at the entrance of the Bordet building. The questionnaire is fully anonymous, and no directly identifiable personal data will be collected.

Other: Quantitative evaluation of cancer patient's use of CAM's

Phase 2 : French-speaking adult cancer survivor patients who have completed active cancer treatment

OTHER

Phase 2 - Interventional mixed-methods evaluation of cancer patient's behaviour regarding CAMs : patients (men and women) after acute phase of anti-cancer treatment. This study will include a total of 6 to 8 focus groups, with each group consisting of 5 to 10 participants. So, in total, we expect 30 to 60 participants. Participants in this arm will take part in semi-structured focus group sessions exploring their knowledge, use, motivations, perceived benefits and risks, sources of information, and expectations regarding CAM in cancer care and survivorship. Before and after the session, participants will complete anonymous questionnaires. Focus groups will last approximately two hours, include up to eight participants, and may use interactive tools to facilitate discussion. Sessions will be audio-recorded with consent, transcribed verbatim, and analyzed using rapid qualitative methods. A structured medication review based on self-reported treat

Other: Interventional mixed-methods evaluation of cancer patient's behaviour regarding CAMs (focus groups)

Interventions

Interventional mixed-methods evaluation of cancer patient's behaviour regarding CAMs (focus groups) OTHER

Before each focus group session, participants will complete an anonymous pre-session questionnaire, including province of residence, to explore potential regional differences in access to CAM resources, healthcare services, and information. Each session will start with a standardized introduction and presentation of the study framework, including the scope and limits of the discussion. Participants will then be invited to share their experiences in a semi-structured group discussion guided by an interview guide developed by the research team. Topics will include knowledge and use CAM, motivations and perceived benefits, perceived risks, concerns and barriers, sources of information, and needs and expectations regarding integrative care and survivorship. Interactive techniques, such as visual supports or mapping exercises, may be used to facilitate discussion. Sessions will be audio-recorded with consent, transcribed verbatim, and analyzed using rapid qualitative methods.

Phase 2 : French-speaking adult cancer survivor patients who have completed active cancer treatment

Quantitative evaluation of cancer patient's use of CAM's OTHER

A fully anonymous survey will be distributed to cancer patients over three months to assess their use of complementary and alternative medicine (CAM). The questionnaire will be available on paper and online via a secure REDCap link or QR code, disseminated through healthcare professionals and non-intrusive hospital channels, including screens and waiting areas. Paper questionnaires will be collected in a dedicated box at the Bordet building entrance. The survey will collect self-reported data on medical history, treatments, symptoms, CAM use, motivations, perceived benefits and risks, information sources, and interest in integrative care programs. Basic sociodemographic data, province of residence, and optional self-identified ethnocultural background will be collected to explore differences in CAM use, access to information, and patient needs by geographic and sociocultural context. No directly identifiable data will be collected, and results will be analyzed in aggregated form.

Phase 1 - quantitative survey : French-speaking cancer patients entering the Bordet Institute

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For quantitative survey :
• French speaking patient entering Bordet Institute.
• For interventional mixed-methods study :
• French speaking adult cancer survivor patients who have completed active cancer treatment. Individuals in remission or undergoing long-term long term oral therapy.

You may not qualify if:

• For quantitative survey:
• Not to have or have had cancer ;
• Have already answered to this survey before.
• For interventional mixed-methods study :
• Patients currently undergoing active cancer treatment

Sponsors & Collaborators

• Jules Bordet Institute: lead
• Université Libre de Bruxelles: collaborator

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

Location

Related Publications (13)

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• Averill JB. Matrix analysis as a complementary analytic strategy in qualitative inquiry. Qual Health Res. 2002 Jul;12(6):855-66. doi: 10.1177/104973230201200611.

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• Lohr AM, Griffin JM, Raygoza JP, Frick MR, Minteer SA, Tilburt JC, Cheville AL, Austin JD. The role of community health workers in a collaborative care management intervention for cancer pain management: a feasibility study for a randomized controlled trial. Ann Palliat Med. 2025 Jan;14(1):13-28. doi: 10.21037/apm-24-125.

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• Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Med Care. 2021 Jun 1;59(Suppl 3):S242-S251. doi: 10.1097/MLR.0000000000001553.

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• Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019 Feb 1;14(1):11. doi: 10.1186/s13012-019-0853-y.

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• Corvaisier M, Duval O, Paillassa J, Hunault-Berger M, Spiesser-Robelet L. [Implementation of pharmaceutical consultations in oncohematology in a teaching hospital: Over one year outcomes]. Ann Pharm Fr. 2023 Jun;81(4):710-719. doi: 10.1016/j.pharma.2022.12.001. Epub 2022 Dec 10. French.

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• Sont OM, Rombouts MD, Crul M. Attitude of healthcare professionals toward the use of complementary and alternative medication during anti-cancer therapy. J Oncol Pharm Pract. 2024 Jun;30(4):628-635. doi: 10.1177/10781552231179899. Epub 2023 May 31.

  PMID: 37259518 BACKGROUND

• Schils A, Lechon AS, Rondeaux S, Souard F, Van Laethem JL, Pochet S, Mathieu V, De Vriese C. Cancer patients' behaviors and attitudes toward natural health products. BMC Complement Med Ther. 2023 Dec 6;23(1):442. doi: 10.1186/s12906-023-04278-0.

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• Wu A, Wu Y, Natarajan V, Singh P, Cheema W, Hossain R, Liu C, Mejia Y, Oo MHH, Valenzano B, Xu Y. Complementary and Alternative Medicine Use in Patients With Cancer and Immigration Background. JCO Glob Oncol. 2023 Jun;9:e2200303. doi: 10.1200/GO.22.00303.

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• Kallman M, Bergstrom S, Carlsson T, Jaras J, Holgersson G, Nordberg JH, Nilsson J, Wode K, Bergqvist M. Use of CAM among cancer patients : Results of a regional survey in Sweden. BMC Complement Med Ther. 2023 Feb 16;23(1):51. doi: 10.1186/s12906-023-03876-2.

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MeSH Terms

Conditions

Neoplasms; Empowerment

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Florence Souard, PhD

  Université Libre de Bruxelles

  STUDY CHAIR

• Laura Polastro, MD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The trial is designed in two phases, not in two arms. The "Arms and Interventions" page does not make it possible to register for two phases, hence we listed it in two arms. The first phase is a quantitative trial (questionnaire, 500 participants); the second phase is a mixed-methods qualitative-quantitative trial (see protocol design).
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Design Prospective, single-center, two-phase study: * Phase 1: anonymous quantitative study based on a self-administered questionnaire collecting, among other variables, health-related patient-reported data, including information on cancer type, treatments and symptoms * Phase 2: Interventional, non-medicinal mixed-methods phase including descriptive questionnaires (pre- and post-session) and semi-structured focus group discussions.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: August 4, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-06

Locations

BE (1)