NCT03263416

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

4.5 years

First QC Date

August 4, 2017

Last Update Submit

January 28, 2022

Conditions

Metastatic Solid Tumor

Keywords

Metastatic solid tumorOral Targeted TherapyTreatment adherence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation

    6 months per patient

  • Quality of life using the QLQ-C30 questionnaire

    6 months per patient

  • Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03

    6 months per patient

Study Arms (2)

Arm A

EXPERIMENTAL
Other: Dedicated and coordinated follow-up

Arm B

OTHER

Standard

Other: Standard follow-up

Interventions

Dedicated and coordinated follow-upOTHER

* 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

Arm A
Standard follow-upOTHER

\- Completion of QLQ-C30 and GIRERD questionnaires

Arm B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinique Claude Bernard

Albi, 81000, France

Location

Centre Hospitalier Intercommunal Castres Mazamet

Castres, 81108, France

Location

Clinique Des Cedres

Cornebarrieu, France

Location

Institut Claudius Regaud

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Neoplasm MetastasisTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Study Officials

  • Christine CHEVREAU, MD

    Institut Universitaire du Cancer Toulouse Oncopole

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 28, 2017

Study Start

July 24, 2017

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

January 31, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)