Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer
8. februar 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
18
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ohio
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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-
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
Ja
Kjønn som er kvalifisert for studier
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
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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 navn:
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.
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
Andre navn:
|
|
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
|
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.
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
Andre navn:
Radiation Oncology Nurse will hand participant the NCI booklet
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
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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.
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Up to 5 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Qualitative assessment of acceptability
Tidsramme: Up to 5 weeks
|
Descriptive statistics will be used to summarize responses to semi-structured interviews
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Up to 5 weeks
|
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Attrition rate to assess feasibility
Tidsramme: Up to 5 weeks
|
Feasibility will be assessed via attrition and consent rates.
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Up to 5 weeks
|
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Consent rate to assess feasibility
Tidsramme: Up to 5 weeks
|
Feasibility will be assessed via attrition and consent rates.
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Up to 5 weeks
|
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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.
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Up to 5 weeks
|
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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.
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Up to 5 weeks
|
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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
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Up to 5 weeks
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Susan Mazanec, PhD, RN, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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 2015
Primær fullføring (Faktiske)
12. januar 2018
Studiet fullført (Faktiske)
12. januar 2018
Datoer for studieregistrering
Først innsendt
14. oktober 2015
Først innsendt som oppfylte QC-kriteriene
14. oktober 2015
Først lagt ut (Anslag)
16. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CASE2315
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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