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

8 februari 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

18

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Andere namen:
  • interventie groep
  • educational content/simulation
Ander: 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.
Ander: Interview
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
Andere namen:
  • semi-structured interview
  • Open ended questions
Actieve vergelijker: Control Group: educational booklet
The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses
Ander: 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.
Ander: Interview
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
Andere namen:
  • semi-structured interview
  • Open ended questions
Gedragsmatig: NCI Booklet
Radiation Oncology Nurse will hand participant the NCI booklet
Andere namen:
  • When Someone You Love is being Treated for Cancer

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Average efficacy of caregiving summary score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Qualitative assessment of acceptability
Tijdsspanne: 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
Tijdsspanne: Up to 5 weeks
Feasibility will be assessed via attrition and consent rates.
Up to 5 weeks
Consent rate to assess feasibility
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Case Comprehensive Cancer Center

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2015

Primaire voltooiing (Werkelijk)

12 januari 2018

Studie voltooiing (Werkelijk)

12 januari 2018

Studieregistratiedata

Eerst ingediend

14 oktober 2015

Eerst ingediend dat voldeed aan de QC-criteria

14 oktober 2015

Eerst geplaatst (Schatting)

16 oktober 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 februari 2019

Laatste update ingediend die voldeed aan QC-criteria

8 februari 2019

Laatst geverifieerd

1 februari 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CASE2315

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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