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Head and Neck CancerNCT03106090

Studying Survivorship Care Plans in Head and Neck Cancer

A study testing educational materials in people with Head and Neck Cancer, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
educational materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
19 Apr 2017to 2 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Health, Duke Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

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

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.

Being tested
educational materials
Keywords
survivorship care plan, head and neck cancer, survivorship
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • educational materialsOther

    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.

Study groups in NCT03106090
Study groupRoleWhat they receive
No SCP ControlNo interventionPatients returning for early follow-up who did not receive SCP.
SOC SCP ControlNo interventionPatients returning for early follow-up who received a standard of care SCP.
eSCP InterventionExperimentalPatients 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.
Receives: Other: educational materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 minutes to complete 3 months after treatment end

  2. 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

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

Secondary outcomes (14)

  1. 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

    Measured: 5 minutes to complete 3 months after treatment end

  2. Distress in head and neck cancer survivors

    Assesses distress through the use of the NCCN Distress Thermometer

    Measured: 5 minutes to complete 3 months after treatment end

  3. 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

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

  4. Change in distress for head and neck cancer survivors

    Assesses distress through the use of the NCCN Distress Thermometer in the intervention group

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

  5. 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

    Measured: 5 minutes to complete 3 months after treatment end

  6. 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

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

  7. 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)

    Measured: 5 minutes to complete 3 months after treatment end

  8. 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

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

  9. Self-efficacy in head and neck cancer survivors

    Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale

    Measured: 5 minutes to complete 3 months after treatment end

  10. Change in self-efficacy in head and neck cancer survivors

    Assesses self-efficacy in cancer patients through the use of the Self-Efficacy Scale

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

  11. 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)

    Measured: 5 minutes to complete 3 months after treatment end

  12. Change in information processing in head and neck cancer survivors

    Assesses information processing through the use of the EORTC QLQ Information Module (QLQ INFO25)

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

  13. 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

    Measured: 5 minutes to complete 3 months after treatment end

  14. 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

    Measured: 10 minutes to complete documentation review of 6 months of PCP records

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2017
  2. Study start19 Apr 2017
  3. Primary completion2 Jan 2020
  4. Study completion2 Jan 2020

Why it stopped: Unable to meet accrual goals.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03106090
Sponsor's protocol ID
Pro00079937
Status last verified
Jan 2020
First submitted
29 Mar 2017
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing educational materials in people with Head and Neck Cancer, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Unable to meet accrual goals.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Head and Neck Cancer Survivor Knowledge (time frame: 5 minutes to complete 3 months after treatment end). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03106090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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