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Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy (STRIDE)

7. august 2026 oppdatert av: Jamie Jacobs, Massachusetts General Hospital

STRIDE: Evidence-Based Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy

The goal of this study is to demonstrate the efficacy of an evidence-based, small-group, telehealth intervention ('STRIDE') for improving patients' ability to cope with side effects from adjuvant endocrine therapy (AET) and adhere to AET medication regimens for patients with hormone-sensitive breast cancer.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Adjuvant Endocrine Therapy (AET) is critical for most patients with hormone sensitive breast cancer. AET side effects cause distress, interfere with medication adherence, and are associated with poorer quality of life (QOL) and higher anxiety. There is a critical need to increase patients' ability to cope with AET side effects and reduce adherence barriers to AET. This project proposes to conduct a multisite randomized controlled efficacy trial in 400 patients taking AET after breast cancer to test the efficacy of STRIDE, a telehealth evidence-based behavioral intervention, compared to Usual Care (UC), for improving patients' ability to cope with AET side effects. Analyses will also examine the effect of STRIDE on patients' self-reported and objective adherence. Finally, the investigative team will explore the effects of the STRIDE intervention on mood, breast cancer symptom distress, and QOL, and whether improvements in coping ability mediate the effects of the STRIDE intervention on AET adherence.

Studietype

Intervensjonell

Registrering (Antatt)

400

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Florida
      • Tampa, Florida, Forente stater, 33612
        • Moffitt Cancer Center
        • Hovedetterforsker:
          • Laura Oswald, PhD
        • Ta kontakt med:
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital
        • Hovedetterforsker:
          • Jamie M Jacobs, PhD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • Female ≥ 21 years old
  • Diagnosis of early-stage (0-IIIb), hormone receptor positive (ER+/PR+) breast cancer
  • Completed primary treatment (surgery, chemotherapy, and/or radiation)
  • Within 3 to 12 months of starting oral adjuvant endocrine therapy (AET)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Ability to read and respond in English or Spanish
  • Distress about AET ≥ 4 on a 0-10 scale

Exclusion Criteria:

  • Cognitive impairment, uncontrolled psychosis, or serious mental illness prohibiting participation in the study as per the judgment of the treating oncologist
  • Enrolled in a clinical trial for AET

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: STRIDE Intervention
Participants randomized to STRIDE will receive a brief, manualized, videoconference intervention with six weekly one-hour sessions in small groups of two to three patients and two individual semi-structured telephone check-ins. Participants will complete questionnaires at baseline, and 3, 6, and 12 months post-baseline.
Atferdsmessig: STRIDE
STRIDE is a 6-session patient-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that targets coping with and managing AET side effects. The intervention incorporates psychoeducation, problem-solving, cognitive restructuring, relaxation training, symptom management skills training, coping effectiveness training, and mindfulness techniques.
Aktiv komparator: Usual Care
Participants randomized to usual care will receive regular oncology follow-up care which entails one follow-up visit with the primary treating oncologist after prescription of AET and as needed contact with a nurse practitioner or RN for symptom control or other medication related questions. Participants will also complete questionnaires at baseline, and 3, 6, and 12 months post-baseline. Participants will be offered one optional STRIDE intervention visit upon completion of the 12-month questionnaire.
Atferdsmessig: Usual Care
Participants randomized to usual care will receive regular oncology follow-up care which entails one follow-up visit with the primary treating oncologist after prescription of AET and as needed contact with a nurse practitioner or RN for symptom control or other medication related questions.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire.
Tidsramme: Up to 12 months post-baseline
Investigators will assess changes in coping via the Measure of Current Stress - Part A (MOCS-A). The MOCS-A is a 13-item survey used to evaluate participants' perceived ability to cope using several skills. Each item is scored on a 0-4 scale, with higher scores indicating greater coping ability.
Up to 12 months post-baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-reported adherence to AET as measured by the Medication Adherence Report Scale (MARS-5).
Tidsramme: Up to 12 months post-baseline
Investigators will assess changes in adherence to treatment via the Medication Adherence Report Scale (MARS-5). The MARS-5 is a 5-tem survey used to measure AET adherence and suboptimal adherence behaviors. The scale consists of five items that are answered on a scale of 1-5, with higher scores indicating greater adherence to the medication.
Up to 12 months post-baseline
Objective AET adherence rates as measured by the Medication Events Monitoring System (MEMS Caps).
Tidsramme: Up to 12 months post-baseline
Participants will store medication in the Medication Event Monitoring System (MEMS Caps) bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. A mean medication adherence rate will be calculated in each group to examine differences in adherence rates and changes across the study period between groups.
Up to 12 months post-baseline

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anxiety and depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).
Tidsramme: Up to 12 months post-baseline
Investigators will assess changes in symptoms of depression and anxiety via the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item, well-validated survey used widely in patients with cancer that contains two subscales assessing symptoms of depression and anxiety over the past week. Items are scored on a 0-3 scale, with higher scores indicating greater anxiety and depressive symptoms.
Up to 12 months post-baseline
Breast cancer symptom distress as measured by the Breast Cancer Prevention Trial Checklist (BCPT).
Tidsramme: Up to 12 months post-baseline
The investigators will examine changes in self-reported symptom distress using the Breast Cancer Prevention Trial Checklist (BCPT). The BCPT is a symptom checklist used to document physical and psychological symptoms associated with endocrine therapy use. The measure includes several clinically relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered). There are 8 subscales: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. For this study, we summed the 8 subscale scores for a total score ranging from 0-72, with higher scores representing greater symptom distress.
Up to 12 months post-baseline
Quality of Life as measured by the Functional Assessment of Cancer Therapy (FACT-B).
Tidsramme: Up to 12 months post-baseline.
Investigators will assess changes in quality of life using the Functional Assessment of Cancer Therapy- Breast (FACT-B). The FACT-B is a well-validated, 37-item survey of five domains of quality of life in patients with breast cancer over the last week: physical, social, emotional, functional, well-being, and a breast cancer-specific subscale. Each item is evaluated on a 0-4 scale. Higher scores indicate greater quality of life.
Up to 12 months post-baseline.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Massachusetts General Hospital

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Jamie M Jacobs, PhD, Massachusetts General Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. februar 2027

Primær fullføring (Antatt)

1. januar 2030

Studiet fullført (Antatt)

1. juni 2031

Datoer for studieregistrering

Først innsendt

7. august 2026

Først innsendt som oppfylte QC-kriteriene

7. august 2026

Først lagt ut (Faktiske)

12. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 26-343
  • 1R01CA316494-01 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

The Harvard Cancer Consortium (HCC) 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: Jamie M. Jacobs. 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

Tilgangskriterier for IPD-deling

Contact the Partners Innovations team at http://www.partners.org/innovation

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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