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. (ADHESIPH)

I

Institut Claudius Regaud

Status

Completed

Conditions

Metastatic Solid Tumor

Treatments

Other: Standard follow-up
Other: Dedicated and coordinated follow-up

Study type

Interventional

Funder types

Other

Identifiers

NCT03263416
17GENE02

Details and patient eligibility

About

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.

Enrollment

186 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with a metastatic solid tumor and starting a first cycle of oral targeted therapy whatever the treatment line
  • Age > or = 18 years old
  • Affiliated to the french social security system
  • Patient must provide written informed consent prior to any study-specific procedure or assessment

Exclusion criteria

  • Patient not available by phone or with no caregiver who can answer the phone for him
  • Pregnant or breastfeeding women
  • 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
  • Patient protected by law

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

186 participants in 2 patient groups

Arm A
Experimental group
Treatment:
Other: Dedicated and coordinated follow-up
Arm B
Other group
Description:
Standard
Treatment:
Other: Standard follow-up

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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