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Studying Survivorship Care Plans in Head and Neck Cancer

14 januari 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

6

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27710
        • Duke Health, Duke Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: No SCP Control
Patients returning for early follow-up who did not receive SCP.
Inget ingripande: SOC SCP Control
Patients returning for early follow-up who received a standard of care SCP.
Experimentell: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Head and Neck Cancer Survivor Knowledge
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Distress in head and neck cancer survivors
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Duke University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 april 2017

Primärt slutförande (Faktisk)

2 januari 2020

Avslutad studie (Faktisk)

2 januari 2020

Studieregistreringsdatum

Först inskickad

29 mars 2017

Först inskickad som uppfyllde QC-kriterierna

4 april 2017

Första postat (Faktisk)

10 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 januari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 januari 2020

Senast verifierad

1 januari 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro00079937

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

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Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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