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Impact of Changing the Appearance of Oral Antineoplastics on Adherence and Continuity of Treatment, Patient-reported Health Outcomes, and Patient Experience of Care

NCT07664683 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 334

Last updated 2026-06-24

No results posted yet for this study

Summary

Oral chemotherapy is a convenient and flexible option for cancer treatment that can improve patients quality of life and increase adherence to treatment compared to traditional intravenous chemotherapy. However, since patients are responsible for taking the medication, there can be issues with continuity and adherence. Like other medications, generics of existing oral chemotherapy have emerged, which help reduce costs and improve access to this therapy. These generics contribute to a more sustainable healthcare system, so it is necessary to implement effective strategies for their adoption.

Although generic treatments have been shown to be just as effective as the original drug, there is no regulation requiring the pill to have the same shape and color as the original (what we refer to as appearance). Additionally, the packaging of the treatment is different as it is specific to each brand. Therefore, a patient on a specific treatment may switch from the original medication to a generic or from one generic to another, which may have a different appearance in both the pill and the packaging.

It has been observed that these changes can lead to medication errors or a loss of patient confidence, resulting in decreased continuity and adherence to treatment. These issues have been seen with other medications for chronic diseases but have not been studied in cancer patients to date. In these patients, despite the nature of the disease suggesting they would be adherent to treatment, previous studies have shown that this is not the case, with only about 70% of patients being adherent. This lack of adherence affects treatment efficacy, increases the risk of disease relapse, and therefore negatively impacts patient s quality of life and survival while also increasing costs.

Therefore, this study focuses on evaluating whether these changes in pill appearance and/or packaging impact treatment continuity and adherence, as well as other relevant patient outcomes and their experience with the healthcare received. Additionally, we want to analyze whether there are patient variables (such as health literacy, age, or clinical variables) that influence the impact of these changes. Given the differences in adherence between men and women, it is essential to conduct these analyses separately for both genders.

The results obtained from this study will contribute to the development of educational strategies for managing oral chemotherapy by patients and healthcare professionals. Additionally, new evidence will be generated to allow decision-makers to establish policies, either by choosing treatments with the least change in appearance or by regulating the appearance of treatments. All of this will contribute to greater treatment effectiveness, improved patient quality of life, and a lower rate of disease recurrence.

Conditions

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Universidad Miguel Hernandez de Elche

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2026-07-31
Completion
2027-06-29

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07664683 on ClinicalTrials.gov