Clinical trial NCT03106090: Studying Survivorship Care Plans in Head and Neck Cancer
Official title: Comparison of Enhanced Survivorship Care Plans in a Head and Neck Cancer Clinic to Standard of Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: survivorship care plan
head and neck cancer
survivorship
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention (group receiving eSCPs) will be compared to 2 control groups: group receiving prior standard of care and standard of care SCP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Head and Neck Cancer Survivor Knowledge
timeFrame: 5 minutes to complete 3 months after treatment end
measure: Change in Head and Neck Cancer Survivor Knowledge
timeFrame: 5 minutes to complete; measured pre-intervention and 3 months after intervention
Secondary outcomes:
measure: Distress in head and neck cancer survivors
timeFrame: 5 minutes to complete 3 months after treatment end
measure: Distress in head and neck cancer survivors
timeFrame: 5 minutes to complete 3 months after treatment end
measure: Change in distress for head and neck cancer survivors
timeFrame: 5 minutes to complete; measured pre-intervention and 3 months after intervention
measure: Change in distress for head and neck cancer survivors
timeFrame: 5 minutes to complete; measured pre-intervention and 3 months after intervention
measure: Uncertainty in head and neck cancer survivors
timeFrame: 5 minutes to complete 3 months after treatment end
measure: Change in uncertainty in head and neck cancer survivors
timeFrame: 5 minutes to complete; measured pre-intervention and 3 months after intervention
measure: Quality of life in head and neck cancer survivors
timeFrame: 5 minutes to complete 3 months after treatment end
measure: Change in quality of life in head and neck cancer survivors
timeFrame: 5 minutes to complete; measured pre-intervention and 3 months after intervention
measure: Self-efficacy in head and neck cancer survivors
timeFrame: 5 minutes to complete 3 months after treatment end
measure: Change in self-efficacy in head and neck cancer survivors
timeFrame: 5 minutes to complete; measured pre-intervention and 3 months after intervention
measure: Information processing in head and neck cancer survivors
timeFrame: 5 minutes to complete 3 months after treatment end
measure: Change in information processing in head and neck cancer survivors
timeFrame: 5 minutes to complete; measured pre-intervention and 3 months after intervention
measure: Survivorship care plan perceptions in head and neck cancer survivors
timeFrame: 5 minutes to complete 3 months after treatment end
measure: Survivorship needs after treatment completion -- primary care provider documentation
timeFrame: 10 minutes to complete documentation review of 6 months of PCP records
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health, Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Deborah H Allen, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: