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Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer

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

The long-term goal of this research is to develop new tools to guide patients, caregivers, and clinicians in making individualized decisions regarding colorectal cancer (CRC) surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract, investigator will analyze surveillance data to determine the effectiveness of CRC surveillance and recurrence risk taking into account different patient and tumor characteristics; identify key issues about CRC surveillance important to patients, caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a patient-centered, risk stratified surveillance strategy by creating an interactive decision aid for use by patients and clinicians.

This protocol addresses a formative step in the creation of the interactive decision aid where patients' information needs and preferences are assessed regarding decisions about surveillance.

The specific aims of this protocol are:

Phase 1 - To interview patients and their caregivers to determine their concerns, preferences and key priorities regarding surveillance after curative resection of colorectal cancer, and

Phase 2 - To refine the key priorities identified in phase 1 through focus groups and surveys with patients and caregivers.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

You are being asked to take part in this research study which is conducted at The University of Texas MD Anderson ("MD Anderson") and the Harris Health System because you (or someone you act as a caregiver for) are undergoing follow-up after curative resection of colorectal cancer.

The goal of this study is to find out the key priorities for patients and their caregivers when it comes to surveillance after curative resection of colorectal cancer. Your responses will help develop decision aids to help future colorectal cancer patients make more informed decisions about surveillance.

If you agree to participate in this study, you will take part in an interview or focus group in person at MD Anderson, the Harris Health System, or the Alliance. The interview or focus group is expected to take between 30 minutes and 1 hour. The interview or focus group will be audiorecorded. Your name or other identifying information will not appear in the transcript. Adept Word Management, a transcription service that has been approved by the institution, may transcribe the interviews.

You will be asked questions about:

  • your priorities and concerns about colorectal cancer surveillance
  • what you know about colorectal cancer and surveillance,
  • your cancer and treatment (or the patients'),
  • the impact or inconvenience that surveillance causes,
  • who you think should make decisions about surveillance,
  • your thoughts about different surveillance scenarios,
  • and general questions about your age, race, sex, education, and income level.

Information about you will be collected from the medical records and existing data in a database of colorectal patients that is used to organize existing information about colorectal patients to better understand the disease. Information collected will include things like age, gender, marital status, information about the tumor, type of surgery, and what treatment was done before and after surgery. There are no other plans to share your information with others outside the study.

Your participation will be over when the interview is complete. If you are undergoing follow-up for colorectal cancer, research staff will look at your medical record after the interview for information about your cancer including tumor characteristics.

Your participation is completely voluntary. Whether you say yes or no will not change your medical care.

Up to 220 patients and their caregivers will participate in this multicenter study. Up to 190 patients and their caregivers will be enrolled at MD Anderson. Up to 10 patients and their caregivers will be enrolled at the Harris Health System.

Studietype

Observationeel

Inschrijving (Werkelijk)

32

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
    • California
      • San Francisco, California, Verenigde Staten, 94143
        • University of California San Francisco
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • University of Texas MD Anderson Cancer Center
      • Houston, Texas, Verenigde Staten, 77026
        • Lyndon B. Johnson General 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

21 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients of MD Anderson Colorectal Center and their caregivers recruited by study staff.

Beschrijving

Inclusion Criteria:

  1. Age 21 or older
  2. Able to read and speak English
  3. Able to undergo a 30 to 60-minute interview or focus group
  4. For phase 1: MD Anderson patient undergoing follow-up for curative resection of stage I-IV colon or rectal cancer OR caregiver of such a patient
  5. For phase 2: Colon or rectal cancer patient

Exclusion Criteria:

N/A

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
Colorectal Cancer Participants
Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
Gedragsmatig: Interviews - Colorectal Cancer Participants
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
Gedragsmatig: Questionnaire
Questionnaire completion asking general health and demographic questions.
Andere namen:
  • Vragenlijst
Gedragsmatig: Focus Groups
Focus groups conducted with participants and caregivers. Up to 4 focus groups conducted with up to 30 participants each. Focus groups expected to take 30 to 60 minutes.
Caregivers of Colorectal Cancer Participants
Caregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
Gedragsmatig: Interviews - Colorectal Cancer Participants
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
Gedragsmatig: Focus Groups
Focus groups conducted with participants and caregivers. Up to 4 focus groups conducted with up to 30 participants each. Focus groups expected to take 30 to 60 minutes.
Gedragsmatig: Interviews - Caregivers of Colorectal Cancer Participants
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effectiveness of Colorectal Cancer (CRC) Surveillance
Tijdsspanne: 1 day
Semi-structured interviews and focus groups reviewed to identify themes related to participants' and caregiver's priorities regarding surveillance of colorectal cancer.
1 day

Medewerkers en onderzoekers

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

Sponsor

M.D. Anderson Cancer Center

Medewerkers

Patient-Centered Outcomes Research Institute
Alliance for Clinical Trials in Oncology

Onderzoekers

  • Hoofdonderzoeker: Robert Volk, PHD, M.D. Anderson Cancer Center
  • Studie stoel: George J. Chang, MD,MS, 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.

Algemene publicaties

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)

16 juli 2014

Primaire voltooiing (Werkelijk)

13 januari 2022

Studie voltooiing (Werkelijk)

13 januari 2022

Studieregistratiedata

Eerst ingediend

13 augustus 2014

Eerst ingediend dat voldeed aan de QC-criteria

13 augustus 2014

Eerst geplaatst (Schatting)

15 augustus 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 februari 2022

Laatste update ingediend die voldeed aan QC-criteria

11 februari 2022

Laatst geverifieerd

1 februari 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PA13-1002
  • CE13-04-6855 (Ander subsidie-/financieringsnummer: Patient-Centered Outcomes Research Institute)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

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