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Application-Enabled Shared Decision-Making

21. april 2021 oppdatert av: Chia-Wen,Chuang, Chang Gung Memorial Hospital

Department of Nursing, Chang Gung Memorial Hospital-Kaohsiung Medical Center,RN, MSN

To develop application-enabled shared decision-making among patients with early breast cancer and evaluate the preliminary effects of the interventions.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Female breast is an amazing organ that it symbolizes not only the female gender, but also the continuity of human race. In the past treating breast cancer may signal a termination of the breast's predestined role in a woman or a mother. Nowadays, surgical treatment of early breast cancer has two options, one is breast-conserving surgery and the other one is total mastectomy. The former treatment option preserves most of the breast tissue but may spare dormant cancer cells in the preserved tissue. The latter treatment option spares no breast tissue and as a result no dormant cancer cells would remain. This treatment dilemma may bother most of the patients especially when they are still under the shade of the bad news. Many women are reluctant to discuss their diseased breasts with their folks or even their doctors because of privacy; instead they would seek information through internet. Unfortunately, most of their final decision is doctor's preferred choice despite they may have doubts or concerns on doctor's choice of treatment.

Share decision making (SDM) is a recently developed strategy that allows patients taking part in their treatment plan. Patients are invited to join the meeting where doctors explain the latest treatment options and patients express their concerns and finally a decision, both doctors' and patients' concerns well integrated, is reached. One of the drawbacks of SDM is too time consuming; doctors have to prepare a lot of pertinent information, while patients have to try their best to understand the provided information, though many patients may not fully understand their treatment options. It has been reported that a well designed patient decision aids (PDAs) could serve as a virtue connection between patients and doctors. Instead of merely taking information from the PDAs, it allows patients to know all the possible options of treatment and the side effects in an interactive way. It is supposed that patients could be well prepared to discuss with their doctors after interaction with the customized PDAs. In Taiwan, decision conflict and decision regret are commonly encountered among most cancer patients. The impetus for developing a PDAs for female breast cancer patients and evaluating its role on lowering decision conflict and decision regret among these patients comes from the high rates of decision conflict and decision regret among cancer patients in Taiwan.

Studietype

Intervensjonell

Registrering (Faktiske)

31

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

      • Taipei, Taiwan
        • Chang Gung memorial hospital

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • women, aged >20 years
  • newly diagnosed early breast cancer (stages 0-II)
  • no surgery yet
  • no metastases
  • tumor size <3 cm

Exclusion Criteria:

•tumor located <2 cm from the nipple

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: shared decision-making group (SDMG)
Receiving mobile application( BC-SDM)
The mobile application (BC-SDM)includes four functions to support SDM activity: "Understanding breast cancer," "Surgical approach," "Choose the right breast cancer knowledge," and "Let's make a decision for myself". Patients first read the information in "Understanding breast cancer" and "Surgical approach" to receive a tailored education in breast cancer
Ingen inngripen: usual care group (UCG)
Receiving material health education

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
knowledge tests
Tidsramme: immediately after the intervention
The knowledge tests included five items,1. Are the survival rates of breast cancer the same with conserving surgery and total mastectomy? 2. Breast-conserving surgery has a higher local-regional recurrence rate? 3. Is radiation therapy required for Breast-conserving surgery? 4. Does total mastectomy require longer recovery time? 5. Do both total mastectomy and breast-conserving surgery have the same bleeding and infection rate? The knowledge tests included five items, such as "Are the survival rates of breast cancer the same with conserving surgery and total mastectomy?" The correct answer was coded as one point. The scores of the knowledge tests ranged from zero to five points. Higher scores indicated more correct knowledge.
immediately after the intervention
decision conflict-sure
Tidsramme: immediately after the intervention
The Decision Conflict Scale (DCS_SURE) included four items: uncertainty, information, values clarity, and support and effective decision. On the scale, "Yes" answers scored one point, while "No" responses were zero points. The higher score, the lesser conflict.
immediately after the intervention
Decision Regret Scale DRS
Tidsramme: immediately after the intervention
The Decision Regret Scale was composed of five items: "It was the right decision," "I regret the choice that was made," "I would go for the same choices if I had to do it over again," "The choices did me a lot of harm," and "The decision was a wise one." Items were scored using a five-point Likert scale, ranging from very agreed (1 point) to very disagreed (5 points), but two items were reversely scored. The higher score, the more regret.
immediately after the intervention

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 (Faktiske)

1. august 2019

Primær fullføring (Faktiske)

31. juli 2020

Studiet fullført (Faktiske)

31. juli 2020

Datoer for studieregistrering

Først innsendt

16. april 2021

Først innsendt som oppfylte QC-kriteriene

21. april 2021

Først lagt ut (Faktiske)

26. april 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. april 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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. .

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