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Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer

8. februar 2019 opdateret af: Case Comprehensive Cancer Center

Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer

Patients with head and neck cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study tests whether different forms of education and support can help family caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, this study wants to compare approaches.One group includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses. The other group receives an educational booklet about caregiving in addition to usual care by their doctors and nurses. The caregiver also completes surveys about his or her emotions, distress, confidence as a care giver, and quality of life. In addition, the study asks the caregiver questions about his or her age, race, ethnicity, marital status, employment status, education, annual household income, and current living arrangements. This pilot study will only be offered at the Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Main Campus.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Aim 1: Conduct a pilot test of the effects of a novel caregiver intervention, as compared to a control group, on family caregiver self-efficacy for caregiving, anxiety, depression, and health-related quality of life.

Aim 2: Explore the acceptability of a caregiver intervention that utilizes simulation.

Aim 3: Assess the feasibility of the intervention. Aim 4: Describe the incidence of patient events that may be impacted by caregiver self-efficacy, such as acute care visits, admissions to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • family member or friend of an adult patient with a new diagnosis of Stage III - IV cancers of the tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, or parotid who is receiving radiation therapy for curative intent
  • identified by the patient as his/her primary caregiver who is providing daily assistance and/or emotional support
  • cognitively intact, as evidenced by orientation to person, place, and time
  • ability to speak, read, and comprehend English

Exclusion Criteria:

  • Caregivers of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care
  • Caregivers who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Group: Caregiver education
The intervention includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses.
Adfærdsmæssigt: In-person education sessions
The intervention will be delivered by a radiation oncology nurse. Each of the four in-person sessions consists of approximately 30 minutes of educational content/simulation that addresses a specific caregiving topic and any issues or concerns that the caregiver may be experiencing.
Andre navne:
  • interventionsgruppe
  • educational content/simulation
Andet: Survey
written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
Andet: Interview
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
Andre navne:
  • semi-structured interview
  • Open ended questions
Aktiv komparator: Control Group: educational booklet
The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses
Andet: Survey
written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
Andet: Interview
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
Andre navne:
  • semi-structured interview
  • Open ended questions
Adfærdsmæssigt: NCI Booklet
Radiation Oncology Nurse will hand participant the NCI booklet
Andre navne:
  • When Someone You Love is being Treated for Cancer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average efficacy of caregiving summary score
Tidsramme: Up to 5 weeks
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Up to 5 weeks
Average anxiety summary score
Tidsramme: Up to 5 weeks
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Up to 5 weeks
Average depression summary score
Tidsramme: Up to 5 weeks
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Up to 5 weeks
Average Health Related Quality of Life (HRQOL) summary score
Tidsramme: Up to 5 weeks
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Up to 5 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Qualitative assessment of acceptability
Tidsramme: Up to 5 weeks
Descriptive statistics will be used to summarize responses to semi-structured interviews
Up to 5 weeks
Attrition rate to assess feasibility
Tidsramme: Up to 5 weeks
Feasibility will be assessed via attrition and consent rates.
Up to 5 weeks
Consent rate to assess feasibility
Tidsramme: Up to 5 weeks
Feasibility will be assessed via attrition and consent rates.
Up to 5 weeks
Total time for delivering intervention to assess costs
Tidsramme: Up to 5 weeks
Time for delivering the intervention will be recorded to aid in assessing costs.
Up to 5 weeks
Average missed checklist items to assess integrity of intervention
Tidsramme: Up to 5 weeks
Integrity of the intervention will be assessed through monitoring of intervention checklist.
Up to 5 weeks
Event rate for patient events
Tidsramme: Up to 5 weeks
Describe the average incidence of all patient events that may be impacted by caregiver self-efficacy. Events may include acute care visits, admission to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course, and others
Up to 5 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Case Comprehensive Cancer Center

Efterforskere

  • Ledende efterforsker: Susan Mazanec, PhD, RN, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

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 (Faktiske)

1. august 2015

Primær færdiggørelse (Faktiske)

12. januar 2018

Studieafslutning (Faktiske)

12. januar 2018

Datoer for studieregistrering

Først indsendt

14. oktober 2015

Først indsendt, der opfyldte QC-kriterier

14. oktober 2015

Først opslået (Skøn)

16. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CASE2315

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