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Effects of Cancer Symptoms on Caregivers

14 februari 2022 bijgewerkt door: M.D. Anderson Cancer Center

Effects of Cancer Symptoms on Minority Caregivers

The primary objectives are to:

1.1 identify and compare the experiences of minority and nonminority caregivers, including the prevalence and severity of physical (fatigue, sleep disturbance) and psychologic (depression, anxiety, stress) symptoms and their influence on caregiver symptom burden; and to

1.2 assess the relationship between caregiver's symptoms (physical and psychologic) and the patient's symptom's at multiple time points over the patient's treatment regimen for advanced solid tumors (lung, breast, cervical, and others).

A secondary objective is to:

1.3 describe the experience of being a minority (African American/Black or Latino) or nonminority person caring for a medically underserved patient with advanced solids tumors (lung, breast, cervical, or others) over the course of the patient's treatment regimen and follow-up clinic visits.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Caregiver:

If you choose to take part in this study, you will be asked to complete 3 study visits over a period of about 20 weeks (the first visit, followed by 2 more visits, usually 3-8 weeks apart). During the first and third visits, you will be asked to take part in an interview that will include questions about your experience as a caregiver to a patient with cancer. The interview will last about 30-45 minutes and will be tape recorded. The text of the interviews will be copied from the tapes to a written format. The study staff will review the content to look for key caregiver concerns and experiences. The PI and study staff will be the only ones who will have access to the tapes and transcripts. All tapes will be destroyed after the study is finished.

You will also be asked to complete some brief surveys about your physical and psychological health, your reactions to being a caregiver, and your beliefs about symptoms and their control. It will take about 30-45 minutes to complete the surveys, each time.

Each study visit will take about 60-90 minutes. If you can not come to the clinic, trained research study staff will contact you by telephone or by a home visit (with your permission) to complete the surveys and interview. After the last of the 3 study visits, your participation will be ended in this study.

This is an investigational study. Up to 125 participants will take part in this multicenter study at 4 sites: Lyndon Baines Johnson Hospital, Ben Taub General Hospital, MD Anderson, and locations in the community identified by the participant and the study team. Up to 40 will be enrolled at MD Anderson.

Patient:

If you choose to take part in this study, you will be asked to complete 3 study visits over a period of about 20 weeks (the first visit, followed by 2 more visits, usually 3-8 weeks apart). During the visits, you will also be asked to complete some surveys about your physical and psychological health, your reactions to your caregiver, and your beliefs about symptoms and their control. It will take about 30 minutes to complete the surveys each time.

Each study visit will take about 45 minutes. If you can not come to the clinic, trained research study staff will contact you by telephone or by a home visit (with your permission) to complete the surveys and interview. After the last of the 3 study visits, your participation in this study will end.

This is an investigational study. Up to 125 patients will take part in this multicenter study at 4 sites: Lyndon Baines Johnson Hospital, Ben Taub General Hospital, MD Anderson and locations in the community identified by the participant and study team. Up to 40 will be enrolled at MD Anderson.

Studietype

Observationeel

Inschrijving (Werkelijk)

199

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
    • Florida
      • Miami, Florida, Verenigde Staten, 33136
        • Jackson Memorial
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, Verenigde Staten, 77030
        • Ben Taub General Hospital
      • Houston, Texas, Verenigde Staten, 77026
        • Lyndon Baines Johnson Hospital

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

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Three groups of caregivers: African American, Latinos, and white non-Latinos.

Beschrijving

Inclusion Criteria:

  1. Caregiver inclusion criteria includes: provides care and/or assistance to a patient receiving new or current treatment - Single or combined chemotherapy, radiotherapy, and/or targeted therapy for advanced solid tumors (lung, breast, cervical, and other).
  2. 18 years of age or older;
  3. self-identified as African-American/Black, Latino, or white, non-Latino;
  4. able to speak English or Spanish (as applicable);
  5. able to read and complete forms or be willing to have the forms read to them by a trained interviewer;
  6. accessible through personal or telephone contact for the duration of the study.
  7. Patient inclusion criteria: Receiving new or current treatment - Single or combined - chemotherapy, radiotherapy, and/or targeted therapy for advanced solid tumors (lung, breast, cervical, and others). Criteria 2-6 are the same as listed under Caregiver Criteria.

Exclusion Criteria: None

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

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
African American caregivers
African American caregivers for patients with advanced non-small cell lung cancer or breast cancer.
Gedragsmatig: Phenomenological Interviews
Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.
Gedragsmatig: Quantitative Interviews
Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.
Andere namen:
  • Vragenlijst
Latino caregivers
Latino caregivers for patients with advanced non-small cell lung cancer or breast cancer.
Gedragsmatig: Phenomenological Interviews
Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.
Gedragsmatig: Quantitative Interviews
Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.
Andere namen:
  • Vragenlijst
White non-Latino caregivers
White non-Latino caregivers for patients with advanced non-small cell lung cancer or breast cancer.
Gedragsmatig: Phenomenological Interviews
Part 1 will collect phenomenologic data to understand the meaning of caregiver burden, and the positive experiences faced when caring for a underserved patient with advanced lung cancer.
Gedragsmatig: Quantitative Interviews
Part 2 will collect quantitative data to determine the prevalence and severity of symptoms experienced by caregivers and their contribution to caregiver burden.
Andere namen:
  • Vragenlijst

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Difference in reduction in psychological (depression, anxiety, stress) and physical symptoms (fatigue, sleep disturbance) between 3 groups of caregivers: African American, Latinos, and white non-Latinos
Tijdsspanne: 20 weeks
20 weeks

Medewerkers en onderzoekers

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

Sponsor

M.D. Anderson Cancer Center

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Guadalupe Palos, DrPH, M.D. Anderson Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

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)

26 januari 2006

Primaire voltooiing (Werkelijk)

20 januari 2022

Studie voltooiing (Werkelijk)

20 januari 2022

Studieregistratiedata

Eerst ingediend

12 juli 2006

Eerst ingediend dat voldeed aan de QC-criteria

12 juli 2006

Eerst geplaatst (Schatting)

14 juli 2006

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 februari 2022

Laatste update ingediend die voldeed aan QC-criteria

14 februari 2022

Laatst geverifieerd

1 februari 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 2005-0404
  • 5 KO7 CA 102482-02 (Ander subsidie-/financieringsnummer: NCI)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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