Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer
8 lutego 2019 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
18
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44106
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
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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.
Inne nazwy:
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.
Inne nazwy:
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Aktywny 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
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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.
Inne nazwy:
Radiation Oncology Nurse will hand participant the NCI booklet
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Average efficacy of caregiving summary score
Ramy czasowe: Up to 5 weeks
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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
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Average anxiety summary score
Ramy czasowe: 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
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Average depression summary score
Ramy czasowe: Up to 5 weeks
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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
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Average Health Related Quality of Life (HRQOL) summary score
Ramy czasowe: Up to 5 weeks
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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
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Qualitative assessment of acceptability
Ramy czasowe: Up to 5 weeks
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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
Ramy czasowe: Up to 5 weeks
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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
Ramy czasowe: 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
Ramy czasowe: Up to 5 weeks
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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
Ramy czasowe: Up to 5 weeks
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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
Ramy czasowe: Up to 5 weeks
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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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Susan Mazanec, PhD, RN, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 sierpnia 2015
Zakończenie podstawowe (Rzeczywisty)
12 stycznia 2018
Ukończenie studiów (Rzeczywisty)
12 stycznia 2018
Daty rejestracji na studia
Pierwszy przesłany
14 października 2015
Pierwszy przesłany, który spełnia kryteria kontroli jakości
14 października 2015
Pierwszy wysłany (Oszacować)
16 października 2015
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
11 lutego 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
8 lutego 2019
Ostatnia weryfikacja
1 lutego 2019
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CASE2315
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .