Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Studying Survivorship Care Plans in Head and Neck Cancer

14. Januar 2020 aktualisiert von: Duke University

Comparison of Enhanced Survivorship Care Plans in a Head and Neck Cancer Clinic to Standard of Care

The study will focus on survivorship care for head and neck cancer patients cared for within Duke Cancer Center clinics. Standardized survivorship care plans (sSCP) are being implemented based on the American Society for Clinical Oncology's criteria. These documents provide a summary of treatment received, and list side effects and follow-up information after cancer treatment. Taking advantage of this transition, the investigator will study three groups of patients: (a) early survivors treated before the sSCP was implemented, (b) early survivors treated after the sSCP was implemented, and (c) current patients who will receive an individualized enhanced SCP (eSCP), which will include additional information tailored to patient preferences. The investigators hypothesize that patients receiving enhanced survivorship care plans will increase their knowledge regarding their health care plan and wellness trajectory; increase their ability to identify the symptoms they most likely can expect as a result of their cancer treatment; and be more likely to engage in conversations with their PCP about healthy behaviors and screening guidelines.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

6

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • North Carolina
      • Durham, North Carolina, Vereinigte Staaten, 27710
        • Duke Health, Duke Cancer Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Completed treatment for a head or neck cancer at Duke Cancer Center within 4 months of consent OR
  • Will complete treatment for a head and neck cancer at Duke Cancer Center within 3 weeks of consent AND
  • Able to read and understand English
  • Capable of giving informed consent
  • Are at least age 18.

Exclusion Criteria:

  • incompetent for interview (documented diagnosis of active psychosis or dementia) or unable to provide informed consent as assessed by the interviewer; or too sick to participate, as judged by a member of the research team

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: No SCP Control
Patients returning for early follow-up who did not receive SCP.
Kein Eingriff: SOC SCP Control
Patients returning for early follow-up who received a standard of care SCP.
Experimental: eSCP Intervention
Patients currently receiving treatment who will be enrolled to receive an "enhanced" SCP (eSCP) with additional information beyond ASCO guidelines tailored to patient concerns and preferences.
Sonstiges: educational materials
The eSCP includes a treatment summary section, a section detailing follow-up and test recommendations, a section on anticipated and potential side effects, as well as additional information specific to their experience/concerns. They will receive a patient education notebook outlining symptoms and their management that is tailored to those that the subject may be likely to experience during their survivorship care trajectory.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Head and Neck Cancer Survivor Knowledge
Zeitfenster: 5 minutes to complete 3 months after treatment end
Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale
5 minutes to complete 3 months after treatment end
Change in Head and Neck Cancer Survivor Knowledge
Zeitfenster: 5 minutes to complete; measured pre-intervention and 3 months after intervention
Assesses survivor knowledge of potential cancer or treatment-related symptoms and knowledge of healthy behaviors through the use of the Head and Neck Cancer Survivor Knowledge Scale in intervention group
5 minutes to complete; measured pre-intervention and 3 months after intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Distress in head and neck cancer survivors
Zeitfenster: 5 minutes to complete 3 months after treatment end
Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist
5 minutes to complete 3 months after treatment end
Distress in head and neck cancer survivors
Zeitfenster: 5 minutes to complete 3 months after treatment end
Assesses distress through the use of the NCCN Distress Thermometer
5 minutes to complete 3 months after treatment end
Change in distress for head and neck cancer survivors
Zeitfenster: 5 minutes to complete; measured pre-intervention and 3 months after intervention
Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist in the intervention group
5 minutes to complete; measured pre-intervention and 3 months after intervention
Change in distress for head and neck cancer survivors
Zeitfenster: 5 minutes to complete; measured pre-intervention and 3 months after intervention
Assesses distress through the use of the NCCN Distress Thermometer in the intervention group
5 minutes to complete; measured pre-intervention and 3 months after intervention
Uncertainty in head and neck cancer survivors
Zeitfenster: 5 minutes to complete 3 months after treatment end
Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form
5 minutes to complete 3 months after treatment end
Change in uncertainty in head and neck cancer survivors
Zeitfenster: 5 minutes to complete; measured pre-intervention and 3 months after intervention
Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form in the intervention group
5 minutes to complete; measured pre-intervention and 3 months after intervention
Quality of life in head and neck cancer survivors
Zeitfenster: 5 minutes to complete 3 months after treatment end
Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35)
5 minutes to complete 3 months after treatment end
Change in quality of life in head and neck cancer survivors
Zeitfenster: 5 minutes to complete; measured pre-intervention and 3 months after intervention
Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35) in the intervention group
5 minutes to complete; measured pre-intervention and 3 months after intervention
Self-efficacy in head and neck cancer survivors
Zeitfenster: 5 minutes to complete 3 months after treatment end
Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
5 minutes to complete 3 months after treatment end
Change in self-efficacy in head and neck cancer survivors
Zeitfenster: 5 minutes to complete; measured pre-intervention and 3 months after intervention
Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
5 minutes to complete; measured pre-intervention and 3 months after intervention
Information processing in head and neck cancer survivors
Zeitfenster: 5 minutes to complete 3 months after treatment end
Assesses information processing in cancer patients through the use of the EORTC QLQ Information Module (QLQ INFO25)
5 minutes to complete 3 months after treatment end
Change in information processing in head and neck cancer survivors
Zeitfenster: 5 minutes to complete; measured pre-intervention and 3 months after intervention
Assesses information processing through the use of the EORTC QLQ Information Module (QLQ INFO25)
5 minutes to complete; measured pre-intervention and 3 months after intervention
Survivorship care plan perceptions in head and neck cancer survivors
Zeitfenster: 5 minutes to complete 3 months after treatment end
Using open ended questions during a qualitative interview, survivors will provide their perception of how survivorship care plans were useful or not in their care
5 minutes to complete 3 months after treatment end
Survivorship needs after treatment completion -- primary care provider documentation
Zeitfenster: 10 minutes to complete documentation review of 6 months of PCP records
Using a documentation checklist developed by the study team, discussions on survivorship needs when returning to clinic will be assessed with a focus on symptom management or incorporation of healthy behaviors to reduce cancer recurrence
10 minutes to complete documentation review of 6 months of PCP records

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Duke University

Ermittler

  • Hauptermittler: Deborah H Allen, PhD, RN, Duke Health

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. April 2017

Primärer Abschluss (Tatsächlich)

2. Januar 2020

Studienabschluss (Tatsächlich)

2. Januar 2020

Studienanmeldedaten

Zuerst eingereicht

29. März 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. April 2017

Zuerst gepostet (Tatsächlich)

10. April 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Januar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Januar 2020

Zuletzt verifiziert

1. Januar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Pro00079937

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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 .

Klinische Studien zur educational materials

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Bosnia & Herzegovina

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren