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.

Metastatic Solid Tumor Clinical Trial

— ADHESIPH  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263416
• Other study ID #: 17GENE02
• Status: Completed
• Phase: N/A
• Start date: July 24, 2017
• Est. completion date: January 25, 2022

Study information

• Verified date: January 2022
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Solid Tumor

Intervention

Other:
• Dedicated and coordinated follow-up
Coordinated follow-up performed by a dedicated nurse with consultations (before treatment initiation and during treatment) and a telephone follow-up during treatment period Pharmaceutical conciliation before treatment initiation made by the Center Pharmacist Completion of QLQ-C30 and GIRERD questionnaires
• Standard follow-up
- Completion of QLQ-C30 and GIRERD questionnaires

Locations

Country	Name	City	State
France	Clinique Claude Bernard	Albi
France	Centre Hospitalier Intercommunal Castres Mazamet	Castres
France	Clinique Des Cedres	Cornebarrieu
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.	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)	6 months per patient
Secondary	Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation		6 months per patient
Secondary	Quality of life using the QLQ-C30 questionnaire		6 months per patient
Secondary	Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03		6 months per patient