Studying Survivorship Care Plans in Head and Neck Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Other: educational materials

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Health, Duke Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No SCP Control; Patients returning for early follow-up who did not receive SCP.
No Intervention: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Head and Neck Cancer Survivor Knowledge	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress in head and neck cancer survivors	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Deborah H Allen, PhD, RN, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Actual): January 2, 2020
• Study Completion (Actual): January 2, 2020

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: head and neck cancer; survivorship; survivorship care plan
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: Pro00079937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No