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Studying Survivorship Care Plans in Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational materials
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring survivorship care plan, head and neck cancer, survivorship

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Health, Duke Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

No SCP Control

SOC SCP Control

eSCP Intervention

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
Distress in head and neck cancer survivors
Assesses distress through the use of the NCCN Distress Thermometer
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
Change in distress for head and neck cancer survivors
Assesses distress through the use of the NCCN Distress Thermometer in the intervention group
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
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
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)
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
Self-efficacy in head and neck cancer survivors
Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
Change in self-efficacy in head and neck cancer survivors
Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
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)
Change in information processing in head and neck cancer survivors
Assesses information processing through the use of the EORTC QLQ Information Module (QLQ INFO25)
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
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

Full Information

First Posted
March 29, 2017
Last Updated
January 14, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03106090
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Unable to meet accrual goals.
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
January 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
survivorship care plan, head and neck cancer, survivorship

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention (group receiving eSCPs) will be compared to 2 control groups: group receiving prior standard of care and standard of care SCP
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No SCP Control
Arm Type
No Intervention
Arm Description
Patients returning for early follow-up who did not receive SCP.
Arm Title
SOC SCP Control
Arm Type
No Intervention
Arm Description
Patients returning for early follow-up who received a standard of care SCP.
Arm Title
eSCP Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
educational materials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Head and Neck Cancer Survivor Knowledge
Description
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
Time Frame
5 minutes to complete 3 months after treatment end
Title
Change in Head and Neck Cancer Survivor Knowledge
Description
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
Time Frame
5 minutes to complete; measured pre-intervention and 3 months after intervention
Secondary Outcome Measure Information:
Title
Distress in head and neck cancer survivors
Description
Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist
Time Frame
5 minutes to complete 3 months after treatment end
Title
Distress in head and neck cancer survivors
Description
Assesses distress through the use of the NCCN Distress Thermometer
Time Frame
5 minutes to complete 3 months after treatment end
Title
Change in distress for head and neck cancer survivors
Description
Assesses risk of distress defined within post-traumatic stress after treatment through the use of the PTSD Checklist in the intervention group
Time Frame
5 minutes to complete; measured pre-intervention and 3 months after intervention
Title
Change in distress for head and neck cancer survivors
Description
Assesses distress through the use of the NCCN Distress Thermometer in the intervention group
Time Frame
5 minutes to complete; measured pre-intervention and 3 months after intervention
Title
Uncertainty in head and neck cancer survivors
Description
Assesses uncertainty related to presence of symptoms after cancer treatment through the use of the Mishel Uncertainty in Illness Scale -Survivor/Caregiver form
Time Frame
5 minutes to complete 3 months after treatment end
Title
Change in uncertainty in head and neck cancer survivors
Description
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
Time Frame
5 minutes to complete; measured pre-intervention and 3 months after intervention
Title
Quality of life in head and neck cancer survivors
Description
Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35)
Time Frame
5 minutes to complete 3 months after treatment end
Title
Change in quality of life in head and neck cancer survivors
Description
Assesses quality of life in head and neck cancer patients EORTC Quality of Life Questionnaire Head & Neck (QLQ H&N35) in the intervention group
Time Frame
5 minutes to complete; measured pre-intervention and 3 months after intervention
Title
Self-efficacy in head and neck cancer survivors
Description
Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
Time Frame
5 minutes to complete 3 months after treatment end
Title
Change in self-efficacy in head and neck cancer survivors
Description
Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale
Time Frame
5 minutes to complete; measured pre-intervention and 3 months after intervention
Title
Information processing in head and neck cancer survivors
Description
Assesses information processing in cancer patients through the use of the EORTC QLQ Information Module (QLQ INFO25)
Time Frame
5 minutes to complete 3 months after treatment end
Title
Change in information processing in head and neck cancer survivors
Description
Assesses information processing through the use of the EORTC QLQ Information Module (QLQ INFO25)
Time Frame
5 minutes to complete; measured pre-intervention and 3 months after intervention
Title
Survivorship care plan perceptions in head and neck cancer survivors
Description
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
Time Frame
5 minutes to complete 3 months after treatment end
Title
Survivorship needs after treatment completion -- primary care provider documentation
Description
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
Time Frame
10 minutes to complete documentation review of 6 months of PCP records

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah H Allen, PhD, RN
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Health, Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Studying Survivorship Care Plans in Head and Neck Cancer

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