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Implementation and Effectiveness Trial of HN-STAR (HN-STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208490
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : May 20, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

People who have been treated for head and neck cancer (HNC survivors) can experience serious consequences from their cancer and its treatment, ongoing risks of new cancers, and other unrelated illnesses. These concerns pose challenges to the provision of comprehensive care to HNC survivors. We created HN-STAR to facilitate and tailor the ongoing care of HNC survivors. Survivors use HN-STAR on a computer or tablet to answer questions about symptoms and health concerns before a routine visit with a cancer care provider. During the clinic visit, the provider uses HN-STAR to see evidence-based recommendations for managing each concern reported by the survivor. The provider and survivor discuss recommendations and select appropriate actions (e.g., testing, referrals, prescriptions, self-management). HN-STAR produces a survivorship care plan that includes all reported concerns and the actions selected in clinic. The survivorship care plan is given to the survivor and the primary care provider. Three months, six months, and nine months later, the survivor uses HN-STAR from home (or clinic) to report their concerns again, and a new survivorship care plan is created each time.

Our trial randomizes ≥30 oncology practices from the National Community Oncology Research Program to use HN-STAR or provide usual care to 350 recent survivors of head and neck cancer. We hypothesize that survivors in the HN-STAR arm will have greater improvement in patient-centered outcomes (including cancer-related well-being, symptoms, and patient activation) over one year compared to survivors in the usual care arm, measured by surveys at baseline and one year later. We also hypothesize that survivors in the HN-STAR arm will be more likely to receive care that is aligned with evidence-based recommendations during the year of the study than survivors in the usual care arm. Our final aim investigates the implementation of HN-STAR in clinical practice, using interviews and surveys of survivors, providers, and other clinic staff to understand the feasibility, acceptability, appropriateness, and other aspects of providing survivorship care to head and neck cancer survivors.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Other: HN-STAR Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Implementation and Effectiveness Trial of HN-STAR
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
HN-STAR Other: HN-STAR Intervention
The Head and Neck Survivorship Tool (HN-STAR) is a web-based tool used to assist clinicians in implementing the ACS/ASCO HNC survivorship guidelines.

No Intervention: Usual Care



Primary Outcome Measures :
  1. Change in HNC-Specific QOL [ Time Frame: Baseline & 1 year ]
    Measured using Trial Outcome Index from the Functional Assessment of Cancer Therapy Head and Neck. It is a 23-item summary measure that ranges from 0 to a maximum of 96 where higher scores indicate better overall physical and functional outcomes.


Secondary Outcome Measures :
  1. Change in QoL [ Time Frame: Baseline & 1 year ]
    Measured using domains and overall measures from the FACT H&N. The total score evaluates overall QoL in Head and Neck Cancer patients and ranges from 0 to 144, with higher scores indicating better overall QoL. Subscales are calculated by summing the relevant questions [answered using a Likert scale ranging from 0 (Not at all) to 4 (Very much)]. Higher scores on subscales represent a better health state.

  2. Change in QoL [ Time Frame: Baseline & 1 year ]
    Measured using scales from the EORTC QLQ-C30. Scales from the EORTC QLQ-C30 evaluate functional status, global health status and symptoms. All scales range from 0 to 100, with higher scores representing higher functioning, QoL or symptoms.

  3. Change symptom burden [ Time Frame: Baseline & 1 year ]
    Measured using scales from the EORTC QLQ-HN43. Symptom subscales from the EORTC QLQ- HN43 range from 0 to 100, with higher scores representing higher symptom burden.

  4. Change in symptom burden [ Time Frame: Baseline & 1 year ]
    Measured using PRO-CTCAE items for relevant symptoms.

  5. Change in pain [ Time Frame: Baseline & 1 year ]
    Measured using Brief Pain Inventory Short Form. Pain severity and interference items are measured using a scale from 0 to 10, with higher scores indicating worse pain or interference. The average is used as a summary measure of pain severity and pain interference.

  6. Change in patient activation [ Time Frame: Baseline & 1 year ]
    Measured using Patient Activation Measure Short Form. PAM score ranges from 0 to 100, with higher score meaning higher level of activation.

  7. Change in perceived quality of cancer care [ Time Frame: Baseline & 1 year ]
    Measured using the CAHPS® Cancer Care Survey.

  8. Adherence and surveillance of guideline concordant care [ Time Frame: These variables will be derived from the medical record during the year following the initial visit. ]
    Rate at which survivors had ≥1 visit to a primary care provider in the year following the initial visit will be compared by arm. Receipt or non-receipt of guideline-concordant cancer surveillance will be derived from the oncology medical records and compared by arm.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Survivor Inclusion Criteria:

  • Age ≥18 years.
  • Diagnosis of head and neck squamous cell carcinoma, specifically oral cavity, larynx, any part of pharynx and unknown squamous cell carcinoma primary.
  • Completed chemotherapy and/or radiation therapy for head and neck squamous cell carcinoma ≤ 6 months prior to enrollment.
  • Deemed free of disease at last assessment.
  • Cognitively and physically able to complete study survey per local NCORP site staff discretion.
  • Plans to attend a clinic visit with a provider who has agreed to participate in the study and meets requirements for the arm to which their practice has been assigned (the practice designated clinician) for routine follow-up.
  • Willing to complete study assessments 3, 6, and 9 months after the designated clinic visit either 1) remotely (via smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer.

Survivor Exclusion Criteria:

  • History of any other cancer, other than non-melanoma skin disease.
  • Head and neck tumor histology of lymphoma, adenocarcinoma or melanoma.
  • Diagnosed with a prior primary head and neck cancer.
  • Does not speak or read English, because the HN-STAR tool is only available in English at this time.
  • Received only surgery as treatment for head and neck cancer.
  • Current or planned enrollment on another interventional symptom management study protocol, as per patient self-report or research staff members' knowledge at the time of consent. Concurrent participation in treatment or imaging studies is allowed.

Designated Clinician Inclusion Criteria:

  • Age > = 18 years
  • MD, DO, NP, or PA
  • Be able to speak and read English, because the HN-STAR tool is only available in English at this time.
  • Routinely provides care for cancer patients or survivors.
  • Is willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit
  • Agrees to participate in two confidential 1-on-1 semi-structured telephone interviews conducted by the Memorial Sloan Kettering (MSK) research associate, which will be taped, transcribed and qualitatively analyzed.
  • Agrees to complete brief post-visit surveys for each study participant.

Stakeholders Inclusion Criteria:

  • Age > = 18
  • Member of the practice clinical or administrative team who is involved in the oversight of the delivery of head and neck cancer survivorship care or who would make decisions about implementing head and neck survivorship tools such as HN-STAR. This could include clinic administrators, nurse navigators, key clinical team members, program directors, information technology specialists, and other staff (e.g., service line or nursing leaders).
  • Agrees to participate in two surveys (pre and post-implementation) and two confidential semi-structured telephone interviews conducted by the Memorial Sloan Kettering (MSK) research associate, which will be taped, transcribed and qualitatively analyzed.
  • Employed for at least one month at the practice.
  • Be able to speak and reads English, because the HN-STAR tool is only available in English at this time.

Stakeholder Exclusion Criteria:

  • Is the designated clinician at the practice.

Primary Care Provider Inclusion Criteria:

  • Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study.
  • Age >= 18
  • MD, DO, NP, or PA
  • Agrees to complete one brief, confidential telephone interview, conducted by the MSK research team, which will be tape, transcribed and qualitatively analyzed.

Primary Care Provider Exclusion Criteria:

  • Provides Oncology Care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208490


Contacts
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Contact: Karen Craver 336-716-0891 NCORP@wakehealth.edu

Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04208490    
Other Study ID Numbers: IRB00060694
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
Time Frame: 6 months after publication for a 2 year duration
Access Criteria: upon request to NCORP@wakehealth.edu
URL: https://nctn-data-archive.nci.nih.gov/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Survivorship
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms