Holistic Evaluation of Approaches to Long-term Health & Survivorship | NCT07745205

NCT07745205

Overview

NCT ID: NCT07745205
Lead Sponsor: Jules Bordet InstituteOTHER
Official Title: 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.
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.

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Jun 8, 2026Actual
Primary Completion Date: Mar 30, 2027Estimated

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 500Estimated
Primary Purpose: Screening
Allocation: Non-Randomized
Interventional Model: Sequential Assignment
Masking

Contacts and Locations

Central Contacts: No data available
Locations: Institut Jules Bordet

Similar Studies

Participant Group/Arms

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

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 treatmentOther

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