Adjuvant Endocrine Therapy Adherence Intervention Pilot in Rwanda
18. maj 2026 opdateret af: Temidayo Fadelu, MD, Dana-Farber Cancer Institute
Piloting an Intervention to Improve Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer in Rwanda
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a randomized study evaluating a light-touch, multi-modal medication adherence support package designed to improve adherence to adjuvant endocrine therapy in adults with confirmed ER-positive breast cancer undergoing curative intent treatment. Eligible participants will be within 6-36 months of adjuvant endocrine therapy initiation and will be randomized to receive either standard care or the medication adherence support package, which includes a one-time educational video, a symptom monitoring card, and weekly one-way text message reminders.
The research study procedures include: screening for eligibility, questionnaires/surveys, interviews, educational video, symptom monitoring card, and weekly text message reminders (as applicable). No additional in-person or telephone contact with research staff is planned beyond delivery of these materials.
It is expected that about 224 adults will take part in this study across all sites.
Participation in this research study is expected to last about 6 months.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
224
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Temidayo Fadelu, MD
- Telefonnummer: 617-632-3779
- E-mail: temidayo_fadelu@dfci.harvard.edu
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Dana-Farber Cancer Institute
-
Kontakt:
- Temidayo Fadelu, MD
- Telefonnummer: 617-632-3779
- E-mail: temidayo_fadelu@dfci.harvard.edu
-
Ledende efterforsker:
- Temidayo Fadelu, MD
-
Boston, Massachusetts, Forenede Stater, 02115
- Boston Children's Hospital
-
Kontakt:
- Temidayo Fadelu, MD
- Telefonnummer: 617-632-3779
- E-mail: temidayo_fadelu@dfci.harvard.edu
-
Ledende efterforsker:
- Temidayo Fadelu, MD
-
Boston, Massachusetts, Forenede Stater, 02053
- Brigham and Women's Hospital
-
Kontakt:
- Temidayo Fadelu, MD
- Telefonnummer: 617-632-3779
- E-mail: temidayo_fadelu@dfci.harvard.edu
-
Ledende efterforsker:
- Temidayo Fadelu, MD
-
-
-
-
RN8
-
Butaro, RN8, Rwanda, 02053
- Butaro Cancer Center of Excellence
-
Ledende efterforsker:
- Temidayo Fadelu, MD
-
Kontakt:
- Temidayo Fadelu, MD
- Telefonnummer: 2406608885
- E-mail: temidayo_fadelu@dfci.harvard.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 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
- Within 6-36 months of starting AET
- Have a cellphone capable of receiving text messages.
- Are currently receiving AET at Butaro or satellite clinics.
Exclusion Criteria:
- 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)
- Prisoners
- Pregnant women
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Styring
Deltagerne vil modtage standard pleje.
|
|
|
Eksperimentel: Intervention
Participants randomized to the intervention arm will receive a light-touch, multi-modal medication adherence support package, including a one-time educational video, a symptom monitoring card, and weekly one-way text message reminders.
|
One-time educational video
Symptom monitoring card
Weekly one-way text reminders
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
3-month Adherence Rate
Tidsramme: 3 months
|
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.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
6-month persistence, 3 and 6 month QOL on FACT
Tidsramme: At 3- and 6-months
|
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.
|
At 3- and 6-months
|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B) Score at 3- and 6-months
Tidsramme: 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.
|
At 3- and 6-months.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Temidayo Fadelu, MD, Dana-Farber Cancer Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
20. september 2026
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2028
Datoer for studieregistrering
Først indsendt
27. april 2026
Først indsendt, der opfyldte QC-kriterier
27. april 2026
Først opslået (Faktiske)
1. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25-838
- 108707 (Andet bevillings-/finansieringsnummer: Harold Amos Medical Faculty Development Program (AMFDP))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials.
De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.
Requests may be directed to: [contact information for Sponsor Investigator or designee].
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov
only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD-delingstidsramme
Data can be shared no earlier than 1 year following the date of publication
IPD-delingsadgangskriterier
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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