Studying Survivorship Care Plans in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03106090
• Other study ID #: Pro00079937
• Status: Terminated
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: January 2, 2020

Study information

• Verified date: January 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Duke Health, Duke Cancer Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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