Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
California
-
San Francisco, California, Vereinigte Staaten, 94143
- University of California San Francisco
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77030
- University of Texas MD Anderson Cancer Center
-
Houston, Texas, Vereinigte Staaten, 77026
- Lyndon B. Johnson General Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Age 21 or older
- Able to read and speak English
- Able to undergo a 30 to 60-minute interview or focus group
- 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
- For phase 2: Colon or rectal cancer patient
Exclusion Criteria:
N/A
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Colorectal Cancer Participants
Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.
|
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection.
Interviews take between 30 minutes and 1 hour.
Questionnaire completion asking general health and demographic questions.
Andere Namen:
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.
|
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection.
Interviews take between 30 minutes and 1 hour.
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.
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection.
Interviews take between 30 minutes and 1 hour.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Effectiveness of Colorectal Cancer (CRC) Surveillance
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Robert Volk, PHD, M.D. Anderson Cancer Center
- Studienstuhl: George J. Chang, MD,MS, M.D. Anderson Cancer Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Zafar SN, Hu CY, Snyder RA, Cuddy A, You YN, Lowenstein LM, Volk RJ, Chang GJ. Predicting Risk of Recurrence After Colorectal Cancer Surgery in the United States: An Analysis of a Special Commission on Cancer National Study. Ann Surg Oncol. 2020 Aug;27(8):2740-2749. doi: 10.1245/s10434-020-08238-7. Epub 2020 Feb 20.
- Snyder RA, Hu CY, Cuddy A, Francescatti AB, Schumacher JR, Van Loon K, You YN, Kozower BD, Greenberg CC, Schrag D, Venook A, McKellar D, Winchester DP, Chang GJ; Alliance for Clinical Trials in Oncology Network Cancer Surveillance Optimization Working Group. Association Between Intensity of Posttreatment Surveillance Testing and Detection of Recurrence in Patients With Colorectal Cancer. JAMA. 2018 May 22;319(20):2104-2115. doi: 10.1001/jama.2018.5816.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PA13-1002
- CE13-04-6855 (Andere Zuschuss-/Finanzierungsnummer: Patient-Centered Outcomes Research Institute)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .