Health Trials

Adjuvant Endocrine Therapy Adherence Intervention Pilot in Rwanda

ConditionsMedication AdherenceBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDana-Farber Cancer Institute

About this trial

This study aims to evaluate a multi-modal intervention designed to improve adherence to adjuvant endocrine therapy (AET) among patients with ER-positive breast cancer in Rwanda. The intervention includes educational, behavioral, and reminder components, and will be assessed for feasibility and impact on medication adherence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients

Age 18 or older

Pathologic confirmation of ER-positive breast cancer

Clinical or radiographic confirmation of disease localized to the breast and regional lymph nodes

Disqualifiers

Unwilling/Unable to participate

Unable to comprehend study languages (English or Kinyarwanda)

Adults unable to consent

Individuals who are not yet adults (infants, children, teenagers)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Educational video

    Behavioral

    One-time educational video

  • Symptom monitoring card

    Behavioral

    Symptom monitoring card

  • Text reminders

    Behavioral

    Weekly one-way text reminders

Treatment groups

224 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 3 interventions
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

3-month Adherence Rate

The proportion of participants adhering to adjuvant endocrine therapy (AET) is based on the Simplified Medication Adherence Questionnaire (SMAQ; Knobel et al. J Acq Immune Deficiency Syndromes 2002). SMAQ is a 6-item assesment tool but only the 4 yes/no questions are used for this endpoint. An affirmative answer to any of the 4 questions defines non-adherent status.

Time frame
3 months

Secondary outcomes

1

6-month persistence, 3 and 6 month QOL on FACT

FACT-ES has 46-items including the 27-item FACT-General (FACT-G) and a 19-item endocrine subscale. (Fallowfield et al. Breast Cancer Research and Treatment 1999) It is scored on a likert scale (0=not at all to 4=very much) with higher scores (range 0-184) indicating better quality of life and fewer symptoms.

Time frame
At 3- and 6-months
2

Functional Assessment of Cancer Therapy-Breast (FACT-B) Score at 3- and 6-months

FACT-B has 37-items including the 27-item FACT-General (FACT-G) and a 10-item breast cancer subscale. (Brady et al. JCO 1997) It is scored on a likert scale (0=not at all to 4=very much) with higher scores (range 0-148) indicating better quality of life and fewer symptoms.

Time frame
At 3- and 6-months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: