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NCT Number: NCT03263416

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.

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.

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Key information

Conditions

Metastatic Solid Tumor Behavior Health Behavior Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Claude Bernard, Albi, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dedicated and coordinated follow-up

Other
  • 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

Other
  • Completion of QLQ-C30 and GIRERD questionnaires

Primary outcomes

  1. Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.

    Time frame: 6 months per patient

    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)

Secondary outcomes

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

    Time frame: 6 months per patient

  2. Quality of life using the QLQ-C30 questionnaire

    Time frame: 6 months per patient

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

    Time frame: 6 months per patient

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Official study 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.

Acronym: ADHESIPH

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2017
Registry last updated
Jan 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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