Clinical trial · Interventional
Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up Compared to Standard Follow-up.
Regional, Multicentric, Randomized Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up (Using a Telephone Follow-up by a Nurse and a Pharmaceutical Conciliation) Compared to Standard Follow-up.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, comparative, open label, randomized, multicentric study evaluating the benefit of a dedicated and coordinated follow-up on treatment adherence in patients with metastatic solid tumor and starting a first cycle of treatment compared to standard follow-up. A dedicated and coordinated follow-up during the treatment period will be based on a telephone follow-up and a pharmaceutical conciliation. Patients will be randomized into one of two study arms: Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a pharmaceutical conciliation made by the Center Pharmacist. Arm B: Standard follow-up during the treatment period. Patients will be followed during 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dedicated and coordinated follow-up | Other | — | UNRESOLVED |
| Standard follow-up | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- interventionNames
- Other: Dedicated and coordinated follow-up
- type
- OTHER
- label
- Arm B
- description
- Standard
- interventionNames
- Other: Standard follow-up
Primary outcomes (1)
- measure
- Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.
- timeFrame
- 6 months per patient
- description
- This outcome will be assessed by the counting of tablets and the completion of the GIRERD questionnaire by the patient (assessment performed at 1, 3 and 6 months during the treatment)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with a metastatic solid tumor and starting a first cycle of oral targeted therapy whatever the treatment line 2. Age \> or = 18 years old 3. Affiliated to the french social security system 4. Patient must provide written informed consent prior to any study-specific procedure or assessment Exclusion Criteria: 1. Patient not available by phone or with no caregiver who can answer the phone for him 2. Pregnant or breastfeeding women 3. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 4. Patient protected by law
References
Publications (0)
Data not yet available