HEALTHS - Holistic Evaluation of Approaches to Long-term Health and Survivorship (Focus Phytotherapy) A Single-center, Minimal-risk, Two-phase Study Including a Quantitative Observational Survey and an Interventional Mixed-methods Component With Focus Group Sessions.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage of Participants Reporting Use of Complementary and Alternative Medicine as Assessed by the HEALTHS Quantitative Questionnaire
研究概览
简要总结
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.
详细描述
- OBJECTIVES The study's objective is threefold including quantitative, qualitative and operational objectives
1.1. Primary objectives (Quantitative - phase 1)
The goal of the quantitative analysis is to provide objective insights into various aspects of patient behavior and need, including :
- Measuring and quantifying usage patterns to determine who takes what kind of CAMs in what purpose ;
- Objectively analyzing behaviors to identify trends and variations across different patient groups ;
- Assessing and defining patient needs and information sources to better understand gaps in care and areas for improvement.
1.2. Secondary objectives (Mixed-methods - phase 2)
The qualitative analysis aims to provide a deeper understanding of patient behaviors, decision-making processes, and contextual influences, including:
- Observation and assessment of current practices ;
- Understanding behavioral patterns in different contexts ;
- Prioritizing needs and expectations ;
- Developing an integrative guidance system supporting patient treatment adherence ;
- Identifying significant roles in guiding patients toward CAM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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).
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Percentage of Participants Reporting Use of Complementary and Alternative Medicine as Assessed by the HEALTHS Quantitative Questionnaire
时间窗: 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
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.
Percentage of Participants Reporting Unmet Needs for Information or Professional Guidance About Complementary and Alternative Medicine as Assessed by the HEALTHS Quantitative Questionnaire
时间窗: 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
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.
Percentage of Participants Reporting Adherence to Prescribed Long-Term Oral Anticancer Therapy as Assessed by the HEALTHS Pre-Focus Group Questionnaire
时间窗: 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.
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.
次要结局
- 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)
- Percentage of Participants Reporting an Intention to Change Their Complementary and Alternative Medicine Behavior as Assessed by the HEALTHS Post-Focus Group Questionnaire(Immediately after completion of the approximately 2-hour focus group session The protocol proposes documenting potential behavioral changes and new influences following the discussion, but it does not include later participant follow-up)
- Percentage of Participants Reporting Perceived Risks or Concerns Related to 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 Interested in an Institutional Integrative Oncology or Survivorship Program as Assessed by the HEALTHS Quantitative Questionnaire(At completion of the Phase 1 quantitative questionnaire, administered once during the 3-month survey recruitment period)
- Patient-Reported Complementary and Alternative Medicine Behaviors, Motivations, Barriers, Information Sources, and Care Expectations Identified Through Semi-Structured Focus Groups(During the single approximately 2-hour focus group session The protocol explicitly describes these focus-group domains and the rapid qualitative matrix-analysis method)
- Percentage of Participants Rating the Focus Group Session as Useful as Assessed by the HEALTHS Post-Focus Group Questionnaire(Immediately after completion of the approximately 2-hour focus group session The protocol identifies perceived usefulness and acceptability of the focus group sessions as secondary assessments.)
- Percentage of Participants Rating the Focus Group Session as Acceptable as Assessed by the HEALTHS Post-Focus Group Questionnaire(Immediately after completion of the approximately 2-hour focus group session Usefulness and acceptability should remain separate outcomes unless the post-focus questionnaire defines a validated or prespecified combined score.)
- Percentage of Participants Requesting Additional Complementary and Alternative Medicine Information or Support as Assessed by the HEALTHS Post-Focus Group Questionnaire(Immediately after completion of the approximately 2-hour focus group session)
- Health Literacy Score as Assessed by the European Health Literacy Survey Questionnaire-16 Items(Before the participant's focus group session The protocol lists the HLS-EU-Q16 as a study questionnaire and states that Phase 2 health-literacy data will be analyzed descriptively.)
- Number of Drug-Related Problems per Participant Identified by Structured Medication Review Using the PCNE Classification Version 9.1(During the Phase 2 medication review conducted in connection with the participant's focus group The protocol states that medication review will use self-reported treatment info and medical records, and that problems will be classified with PCNE 9.1)
- Percentage of Participants With at Least One Drug-Related Problem Identified by Structured Medication Review Using the PCNE Classification Version 9.1(During the Phase 2 medication review conducted in connection with the participant's focus group session)
- Distribution of Drug-Related Problem Types Identified by Structured Medication Review Using the PCNE Classification Version 9.1(During the Phase 2 medication review conducted in connection with the participant's focus group session This must be separate from "number of drug-related problems per participant" because the present outcome's unit is the number or % of problems in PCNE)
- Percentage of Participants With a Potential Interaction Between Conventional Treatment and a Herbal or Natural Health Product Identified by Structured Medication Review(During the Phase 2 medication review conducted in connection with the participant's focus group session)