Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Evaluation of a Patient-Centered Decision-Making Support Tool for Older Adults With Advanced Breast Cancer and Their Care Partners (PCDM)

21. mai 2026 oppdatert av: Allison Magnuson, University of Rochester
The purpose of this study is to determine the feasibility for a patient centered decision-making support tool for older adults with metastatic breast cancer and their care partners.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Detaljert beskrivelse

The primary objective (Aim 1) of this study will be to evaluate feasibility of utilizing the patient-centered decision-making (PCDM) tool for older adults with metastatic breast cancer (mBC). The PCDM tool has been developed by the investigators in collaboration with Manta Cares, Inc. During the development process, we have integrated Geriatric Assessment (GA), completed fully by patients, into the PCDM tool, along with potential supportive care strategies (e.g., recommendations) that could be considered by patients and their care partners if areas of impairment are noted on the GA embedded into the PDCM tool. Feasibility of the adapted PCDM tool will be assessed both quantitatively and qualitatively, and through mixed methods (integrating quantitative and qualitative data) to provide a deeper understanding of aspects of implementation across settings.

Studietype

Intervensjonell

Registrering (Antatt)

150

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

    • New York
      • Rochester, New York, Forente stater, 14620
        • University of Rochester

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

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

Patient Inclusion Criteria:

  1. A diagnosis of metastatic breast cancer
  2. Age 65 or older
  3. Currently receiving systemic treatment for metastatic breast cancer or considering a plan to initiate systemic treatment for metastatic breast cancer
  4. Able to speak and read English (because the Manta Cares platform is presently only offered in English only)
  5. Able to provide informed consent

Care Partner Inclusion Criteria:

  1. Age 18 or older
  2. Able to speak and read English (because the Manta Cares platform is presently only offered in English only)
  3. Able to provide informed consent
  4. Verbal permission from patient to enroll their designated care partner

Exclusion Criteria:

Patient Exclusion Criteria:

  1. Early-stage breast cancer
  2. Diagnosis of any other cancer besides metastatic breast cancer

Care Partner Exclusion Criteria:

1. Verbal permission from patient to enroll care partner not received.

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: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient and care partner Acceptability of Intervention (AIM)
Tidsramme: Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Measure different aspects of intervention implementation. The AIM, IAM, and FIM measures were jointly developed through a consensus process involving 63 experts (e.g., implementation scientists, health professionals), and psychometric properties for the three scales have been established. All three scales were developed to evaluate fit or match of a potential intervention (acceptability measure evaluates personal fit to the individual, appropriateness measure evaluates the societal or technical fit, and the feasibility measure evaluates practical fit. Each scale has 4-items with a 5-point Likert scale response (total score 4-20 for each measure), for a total of 12 items for all three scales. No specialized training is needed to administer or score the measure and it is written at a 5th grade reading level. Although cut-off scores for interpretation are not available, higher scores indicate greater degree of acceptability, appropriateness, and feasibility respectively.
Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Intervention Appropriateness Measure (IAM)
Tidsramme: Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Measure different aspects of intervention implementation. The AIM, IAM, and FIM measures were jointly developed through a consensus process involving 63 experts (e.g., implementation scientists, health professionals), and psychometric properties for the three scales have been established. All three scales were developed to evaluate fit or match of a potential intervention (acceptability measure evaluates personal fit to the individual, appropriateness measure evaluates the societal or technical fit, and the feasibility measure evaluates practical fit. Each scale has 4-items with a 5-point Likert scale response (total score 4-20 for each measure), for a total of 12 items for all three scales. No specialized training is needed to administer or score the measure and it is written at a 5th grade reading level. Although cut-off scores for interpretation are not available, higher scores indicate greater degree of acceptability, appropriateness, and feasibility respectively.
Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Feasibility of Intervention (FIM)
Tidsramme: Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Measure different aspects of intervention implementation. The AIM, IAM, and FIM measures were jointly developed through a consensus process involving 63 experts (e.g., implementation scientists, health professionals), and psychometric properties for the three scales have been established. All three scales were developed to evaluate fit or match of a potential intervention (acceptability measure evaluates personal fit to the individual, appropriateness measure evaluates the societal or technical fit, and the feasibility measure evaluates practical fit. Each scale has 4-items with a 5-point Likert scale response (total score 4-20 for each measure), for a total of 12 items for all three scales. No specialized training is needed to administer or score the measure and it is written at a 5th grade reading level. Although cut-off scores for interpretation are not available, higher scores indicate greater degree of acceptability, appropriateness, and feasibility respectively.
Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Activation Measure-13 (PAM-13)
Tidsramme: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
The PAM 13 (originally developed as a 22-item measure and later modified to 13 items) is a valid and reliable tool to measure stages of activation, including belief that the patient role is important and having the confidence and knowledge to take action. The PAM-13 is scored 0-100, with higher scores indicating greater patient activation.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Decision Self-Efficacy Scale (DSE)
Tidsramme: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
The DSE scale measures self-confidence and belief in one's abilities in decision-making. The 11-item questionnaire assesses confidence in aspects such as ability to get the facts about treatment options available, including choices and benefits and side effects of choices, and ability to understand the information and ask questions/express concerns. Scoring is converted to a 0-100 scale, with higher scores indicating greater self-efficacy in decision-making. Prior studies suggest that scores below 70 were observed in patients who were significantly less likely to engage in shared decision-making and more likely to report decision regret later.43-45 This measure has been utilized in other studies of patients with advanced cancer.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Shared Decision-Making Questionnaire (SDM-Q-9)
Tidsramme: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
The SDM-Q-9 measures the extent to which patients are involved in the process of decision-making from the perspective of the patient. The instrument has 9 questions and is a reliable and well accepted, with high internal consistency and discriminative validity. The measure is scored on a scale of 0-100 and can be used to assess longitudinal change in shared decision making in clinical settings with an MCID of 4 points used in prior studies.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Caregiver Activation Measure (CG-PAM)
Tidsramme: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Caregiver Activation Measure: A measure that was developed and validated to assess care partner's' knowledge, skill, and confidence for self-management of a chronic medical condition. Greater degrees of activation (e.g., higher degree of knowledge, skill, and confidence) can facilitate the shared decision-making process.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Heath Care Climate Questionnaire (HCCQ)
Tidsramme: Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
The HCCQ is a measure of satisfaction with communication that evaluates patients and care partners perceptions of autonomy support and shared decision making and evaluates whether they feel their oncology clinician(s) understand their perspective, provides choices, and encourage participation in decisions. The HCCQ measure has been validated in older adult populations. The full HCCQ scale has a reliability of >0.9. The six-item version will be utilized, which has demonstrated excellent internal consistency and construct validity in the oncology setting.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)

Samarbeidspartnere og etterforskere

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

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. august 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

14. mai 2026

Først innsendt som oppfylte QC-kriteriene

14. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • UOCPC25063
  • STUDY00010968 (Annen identifikator: University of Rochester)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere