Studying Survivorship Care Plans in Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Other: educational materials
- Registration Number
- NCT03106090
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description eSCP Intervention educational materials 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.
- Primary Outcome Measures
Name Time Method Head and Neck Cancer Survivor Knowledge 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
Change in Head and Neck Cancer Survivor Knowledge 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
- Secondary Outcome Measures
Name Time Method Self-efficacy in head and neck cancer survivors 5 minutes to complete 3 months after treatment end Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
Change in self-efficacy in head and neck cancer survivors 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
Change in distress for head and neck cancer survivors 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
Distress in head and neck cancer survivors 5 minutes to complete 3 months after treatment end Assesses distress through the use of the NCCN Distress Thermometer
Change in quality of life in head and neck cancer survivors 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
Information processing in head and neck cancer survivors 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)
Change in information processing in head and neck cancer survivors 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)
Uncertainty in head and neck cancer survivors 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
Survivorship care plan perceptions in head and neck cancer survivors 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
Quality of life in head and neck cancer survivors 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)
Change in uncertainty in head and neck cancer survivors 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
Survivorship needs after treatment completion -- primary care provider documentation 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
Trial Locations
- Locations (1)
Duke Health, Duke Cancer Center
🇺🇸Durham, North Carolina, United States