Studying Survivorship Care Plans in Head and Neck Cancer

NCT03106090 | Terminated

• 1 other identifier: Pro00079937
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

survivorship care plan; head and neck cancer; survivorship

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Distress in head and neck cancer survivors

  5 minutes to complete 3 months after treatment end

• Distress in head and neck cancer survivors

  5 minutes to complete 3 months after treatment end

• Change in distress for head and neck cancer survivors

  5 minutes to complete; measured pre-intervention and 3 months after intervention

• Change in distress for head and neck cancer survivors

  5 minutes to complete; measured pre-intervention and 3 months after intervention

• Uncertainty in head and neck cancer survivors

  5 minutes to complete 3 months after treatment end

Study Arms (3)

No SCP Control

NO INTERVENTION

Patients returning for early follow-up who did not receive SCP.

SOC SCP Control

NO INTERVENTION

Patients returning for early follow-up who received a standard of care SCP.

eSCP Intervention

EXPERIMENTAL

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

Interventions

educational materials OTHER

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.

eSCP Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Health, Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Deborah H Allen, PhD, RN

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention (group receiving eSCPs) will be compared to 2 control groups: group receiving prior standard of care and standard of care SCP

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 10, 2017
• Study Start: April 19, 2017
• Primary Completion: January 2, 2020
• Study Completion: January 2, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)