Studying Survivorship Care Plans in Head and Neck Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: educational materials


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention (group receiving eSCPs) will be compared to 2 control groups: group receiving prior standard of care and standard of care SCP
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No SCP Control<br>Patients returning for early follow-up who did not receive SCP. | |
| No Intervention: SOC SCP Control<br>Patients returning for early follow-up who received a standard of care SCP. | |
| Experimental: eSCP Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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survivorship care plan, head and neck cancer, survivorship