Skip to content

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03106090
Enrollment
6
Registered
2017-04-10
Start date
2017-04-19
Completion date
2020-01-02
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

survivorship care plan, head and neck cancer, survivorship

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.

Interventions

OTHEReducational 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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Head and Neck Cancer Survivor Knowledge5 minutes to complete 3 months after treatment endAssesses 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 Knowledge5 minutes to complete; measured pre-intervention and 3 months after interventionAssesses 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

MeasureTime frameDescription
Uncertainty in head and neck cancer survivors5 minutes to complete 3 months after treatment endAssesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form
Change in uncertainty in head and neck cancer survivors5 minutes to complete; measured pre-intervention and 3 months after interventionAssesses 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
Quality of life in head and neck cancer survivors5 minutes to complete 3 months after treatment endAssesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35)
Change in quality of life in head and neck cancer survivors5 minutes to complete; measured pre-intervention and 3 months after interventionAssesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35) in the intervention group
Self-efficacy in head and neck cancer survivors5 minutes to complete 3 months after treatment endAssesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
Distress in head and neck cancer survivors5 minutes to complete 3 months after treatment endAssesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist
Information processing in head and neck cancer survivors5 minutes to complete 3 months after treatment endAssesses 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 survivors5 minutes to complete; measured pre-intervention and 3 months after interventionAssesses information processing through the use of the EORTC QLQ Information Module (QLQ INFO25)
Survivorship care plan perceptions in head and neck cancer survivors5 minutes to complete 3 months after treatment endUsing open ended questions during a qualitative interview, survivors will provide their perception of how survivorship care plans were useful or not in their care
Survivorship needs after treatment completion -- primary care provider documentation10 minutes to complete documentation review of 6 months of PCP recordsUsing 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
Change in self-efficacy in head and neck cancer survivors5 minutes to complete; measured pre-intervention and 3 months after interventionAssesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
Change in distress for head and neck cancer survivors5 minutes to complete; measured pre-intervention and 3 months after interventionAssesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist in the intervention group

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026