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NCT Number: NCT05345587

Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy

Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital.

Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient.

Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally.

Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Dubois Brive, Brive-la-Gaillarde, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient starting oral therapy treatment in oncology for metastatic or locally advanced cancer
  • Patient able to use a connected electronic object
  • Patient with a smartphone/tablet or computer with internet access and an email address.
  • Patient with WHO status ≤2
  • Patients receiving other cancer therapy concurrently with oral therapy may be included
  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan

Exclusion criteria

  • The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient pregnant, parturient or breast feeding
  • Illiterate patient
  • Patients with poor prognosis due to a serious uncontrolled medical condition, mild systemic disease, uncontrolled infection (cardiac, pulmonary, renal, etc.)
  • Patient receiving hormone therapy alone for breast or prostate cancer

Treatment and study plan

THESS monitoring

Other

Consultation with the pharmacist to look for possible medication interactions between the oral therapy and the patient's usual treatments and to inform the patient about his treatment to improve QOL and compliance. Consultation and follow-up by a nurse. Weekly notification by THESS Application of the symptoms experienced by the patient over the last 7 days

Primary outcomes

  1. Time until decrease in quality of life by 5-points between groups

    Time frame: End of follow-up maximum 18 months

    Quality of life calculated every 3 months using EORTC QLQ-C30 for which a decrease of 5-points is considered to be the minimal clinically important difference

Secondary outcomes

  1. Time until progression of cancer between groups

    Time frame: End of follow-up maximum 18 months

    Measured every 3 months by the Response Evaluation Criteria in Solid Tumours (RECIST) criteria, classed as: Complete response (CR), Partial response (PR), Stable disease (SD), or Progressive disease (PD)

  2. Patient satisfaction with their treatment between groups

    Time frame: 3 months

    The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.

  3. Patient satisfaction with their treatment between groups

    Time frame: 6 months

    The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.

  4. Patient satisfaction with their treatment between groups

    Time frame: 9 months

    The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.

  5. Patient satisfaction with their treatment between groups

    Time frame: 12 months

    The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.

  6. Patient satisfaction with their treatment between groups

    Time frame: 15 months

    The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.

  7. Patient satisfaction with their treatment between groups

    Time frame: 18 months

    The EORTC PATSAT-C33 questionnaire assesses the delivery of oncology care as a whole with a score from 1-5; the EORTC OUT-PATSAT7 is a complementary questionnaire to assess the delivery of ambulatory oncology care with a score from 1-5.

  8. Quality of life adjusted years between groups

    Time frame: 18 months

    EuroQol-5 Dimension (EQ5D-3L) questionnaire, presented as 5-digit number

  9. Cost of care between groups

    Time frame: End of study (18 months)

    The cost of the system will be estimated from the point of view of the health care institution by valuing the time of the medical and nursing staff and patient out-of-pocket expenses

  10. Toxicity experienced during treatment between groups

    Time frame: 3 months

    National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)

  11. Toxicity experienced during treatment between groups

    Time frame: 6 months

    National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)

  12. Toxicity experienced during treatment between groups

    Time frame: 9 months

    National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)

  13. Toxicity experienced during treatment between groups

    Time frame: 12 months

    National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)

  14. Toxicity experienced during treatment between groups

    Time frame: 15 months

    National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)

  15. Toxicity experienced during treatment between groups

    Time frame: 18 months

    National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)

  16. Relative Dose Intensity between groups

    Time frame: 3 months

    % doses received/dose planned

  17. Relative Dose Intensity between groups

    Time frame: 6 months

    % doses received/dose planned

  18. Relative Dose Intensity between groups

    Time frame: 9 months

    % doses received/dose planned

  19. Relative Dose Intensity between groups

    Time frame: 12 months

    % doses received/dose planned

  20. Relative Dose Intensity between groups

    Time frame: 15 months

    % doses received/dose planned

  21. Relative Dose Intensity between groups

    Time frame: 18 months

    % doses received/dose planned

  22. Budget Impact Analysis

    Time frame: After 2 years

    Cost of care for the population reached (actual population treated) on a national scale in Euros

  23. Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

    Time frame: 3 months

  24. Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

    Time frame: 6 months

  25. Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

    Time frame: 9 months

  26. Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

    Time frame: 12 months

  27. Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

    Time frame: 15 months

  28. Rate of prescription changes since initiation of oral therapy (whether change in usual treatment and oral therapy).

    Time frame: 18 months

  29. Medication observance

    Time frame: 3 months

    Girerd questionnaire; score 0-6

  30. Medication observance

    Time frame: 6

    Girerd questionnaire; score 0-6

  31. Medication observance

    Time frame: 9 months

    Girerd questionnaire; score 0-6

  32. Medication observance

    Time frame: 12 months

    Girerd questionnaire; score 0-6

  33. Medication observance

    Time frame: 15 months

    Girerd questionnaire; score 0-6

  34. Medication observance

    Time frame: 18 months

    Girerd questionnaire; score 0-6

  35. Usability of the Thess monitoring patient interface for the collection of Patient Reported Outcomes

    Time frame: Month 18

    System Usability Scale questionnaire; score 0-100

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric Fiteni

CONTACT

[email protected]

04.34.03.46.69

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: PROLIFE

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 26, 2022
Registry last updated
Apr 26, 2024

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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