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Studying Survivorship Care Plans in Head and Neck Cancer

14. januar 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

6

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Health, Duke Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: No SCP Control
Patients returning for early follow-up who did not receive SCP.
Ingen indgriben: SOC SCP Control
Patients returning for early follow-up who received a standard of care SCP.
Eksperimentel: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Head and Neck Cancer Survivor Knowledge
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Distress in head and neck cancer survivors
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Duke University

Efterforskere

  • Ledende efterforsker: Deborah H Allen, PhD, RN, Duke Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. april 2017

Primær færdiggørelse (Faktiske)

2. januar 2020

Studieafslutning (Faktiske)

2. januar 2020

Datoer for studieregistrering

Først indsendt

29. marts 2017

Først indsendt, der opfyldte QC-kriterier

4. april 2017

Først opslået (Faktiske)

10. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00079937

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