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

NCT07664683 | Recruiting DMC

• 1 other identifier: APARENTE
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

Brief 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

Adherence, Patient; Cancer

Keywords

adherence; patient care; PROMS; PREMS; oral antineoplastic drug; appearance

Outcome Measures

Primary Outcomes (1)

• Percentage of adherent patients according to the combination of adherence assessments

  The impact will be measured by: 1. EXPeriencia con y ADherencia a AntiNEoplasicos Orales (EXPAD-ANEO adherence scale)(Talens A et al, Frontiers in Pharmacology, 2023). 2. Tablet counting. The scale will be applied at baseline to assess adherence to treatment prior to switching. It will also be determined twice during the six-month follow-up of the study (at the third and sixth dispensing). This scale includes 7 criteria and is developed and validated in Spain by the research team. Tablet count will be assessed at the baseline visit, before the change of treatment and during follow-up (at the third and sixth), together with the application of the EXPAD-ANEO scale.) Both measures of adherence will be complementary. A patient will be considered adherent if the tablet count is above 90% and meets the 7 criteria of the scale. Adherence will also be assessed in patients who have not come to pick up a dose, but come to pick up their medication at another dose during the prospective study.

  From June 2025 to June 2027

Secondary Outcomes (8)

• 1. 1 Number of changes in the appearance of ANEO medication included in the pharmacotherapeutic guide of three hospitals.

  From June 2025 to June 2027

• 1.2 Type of changes in the ANEOs

  From June 2025 to June 2027

• 1. 3 Reasons for the change

  From June 2025 to June 2027

• 1.4 Percentage of patients affected by the change in ANEO

  From June 2025 to June 2027

• 2.To assess the impact of change in the appearance of the prescribed ANEO on patient-reported health outcomes (PROMs).

  From June 2025 to June 2027

Study Arms (2)

Secondary outcomes 2-5. Quantitative analysis

Patients treated in Dept 20- Elche-Hospital General and Dept. 17- Alicante-S Joan, Dpto. 19 Alicante Hospital General Universitario Dr Balmis d'Alacant, under treatment with ANEO(oral antineoplastic drug ) for at least 6 months and who are autonomous in taking their medication

Secondary outcome 2. Qualitative Analysis

A qualitative focus group design with patients from the Spanish Patients' Forum,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The 2023 data from the hospitals where the study will be carried out shows that 517 patients were treated with one of the ANEOs included in the study. Given the required sample size of 334 patients, 112 patients will be consecutively admitted to each hospital, including those who meet the eligibility criteria, and will be followed for six months. For the qualitative investigation of objective 2 and participation in the focus groups, cancer patients treated with ANEOs will be contacted via the Spanish Patient Forum (3 gruops, 8-12 participants each)

You may qualify if:

• ANEOs included in the pharmacotherapeutic guide of the three hospitals for two years of follow-up (June 2025-2027) will be included.
• Objectives 2-5:
• Patients on treatment for at least 6 months with one of the following ANEOs will be included: capecitabine (L01BC06) (not used as adjuvant in short cycles), imatinib (L01EA01), everolimus (L04AA18), abiraterone (L02BX03) and lenalidomide (L04AX04), at the time of a change in their usual treatment (from brand to generic or between two generics).
• Patients on treatment with ANEOs who meet the established criteria and who change their treatment from brand to generic or from one generic to another generic during the study period may also be included.

You may not qualify if:

• Individuals who collect medication for others and those who are institutionalised will be excluded.
• Patients who have been admitted to hospital in the last 4 weeks are also excluded, due to the increased control of their medication.
• Objective 2( Qualitative analysis)
• \- Spanish Patient Forum

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Universidad Miguel Hernández

San Juan, Alicante, 03550, Spain

RECRUITING

MeSH Terms

Conditions

Patient Compliance; Neoplasms

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Elsa Dr. Elsa López

CONTACT

+34 965919414; elsa.lopez@umh.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer in Pharmacy

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: June 24, 2026
• Study Start: December 8, 2025
• Primary Completion: July 1, 2026
• Study Completion (Estimated): June 29, 2027
• Last Updated: June 24, 2026

Record last verified: 2025-10

Locations

ES (1)