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 20-36 oncology practices from the National Community Oncology Research Program to use HN-STAR or provide usual care to 298-400 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.
Our trial randomizes 20-36 oncology practices from the National Community Oncology Research Program to use HN-STAR or provide usual care to 298-400 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.
Brief Title
Implementation and Effectiveness Trial of HN-STAR
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Head and Neck Cancer
Eligibility Criteria
Survivor Inclusion Criteria:
* Age ≥18 years.
* Diagnosis of primary or locoregionally recurrent head and neck squamous cell carcinoma, specifically oral cavity, larynx, oropharynx, hypopharynx, and unknown squamous cell carcinoma primary.
* Completed chemotherapy and/or radiation therapy with curative intent for head and neck squamous cell carcinoma ≤ 24 months prior to designated clinician visit.
* Deemed free of disease at last assessment.
* Cognitively and physically able to complete study survey per local NCORP site staff discretion.
* Scheduled for a clinic visit with a provider who has agreed to participate in this 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 telephone or videoconference using smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer.
Survivor Exclusion Criteria:
* In active cancer treatment (including hormone therapy) for any other cancer, excluding local therapy for non-melanoma skin cancer.
* Evidence of prior cancer (excluding non-melanoma skin cancer) within 3 years of the designated clinician visit.
* Head and neck tumor histology of lymphoma, adenocarcinoma or melanoma.
* Recurrent, persistent, or progressive disease at last assessment (per scan or clinical assessment).
* 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, planned enrollment, or in follow-up 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
* 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.
* Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit
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, and other staff (e.g., service line or nursing leaders).
* Employed for at least one month at the practice.
* 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
Primary Care Provider Exclusion Criteria:
* Provides Oncology Care
* Age ≥18 years.
* Diagnosis of primary or locoregionally recurrent head and neck squamous cell carcinoma, specifically oral cavity, larynx, oropharynx, hypopharynx, and unknown squamous cell carcinoma primary.
* Completed chemotherapy and/or radiation therapy with curative intent for head and neck squamous cell carcinoma ≤ 24 months prior to designated clinician visit.
* Deemed free of disease at last assessment.
* Cognitively and physically able to complete study survey per local NCORP site staff discretion.
* Scheduled for a clinic visit with a provider who has agreed to participate in this 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 telephone or videoconference using smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer.
Survivor Exclusion Criteria:
* In active cancer treatment (including hormone therapy) for any other cancer, excluding local therapy for non-melanoma skin cancer.
* Evidence of prior cancer (excluding non-melanoma skin cancer) within 3 years of the designated clinician visit.
* Head and neck tumor histology of lymphoma, adenocarcinoma or melanoma.
* Recurrent, persistent, or progressive disease at last assessment (per scan or clinical assessment).
* 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, planned enrollment, or in follow-up 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
* 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.
* Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit
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, and other staff (e.g., service line or nursing leaders).
* Employed for at least one month at the practice.
* 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
Primary Care Provider Exclusion Criteria:
* Provides Oncology Care
Inclusion Criteria
Inclusion Criteria:
* Age ≥18 years.
* Diagnosis of primary or locoregionally recurrent head and neck squamous cell carcinoma, specifically oral cavity, larynx, oropharynx, hypopharynx, and unknown squamous cell carcinoma primary.
* Completed chemotherapy and/or radiation therapy with curative intent for head and neck squamous cell carcinoma ≤ 24 months prior to designated clinician visit.
* Deemed free of disease at last assessment.
* Cognitively and physically able to complete study survey per local NCORP site staff discretion.
* Scheduled for a clinic visit with a provider who has agreed to participate in this 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 telephone or videoconference using smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer.
Survivor Inclusion Criteria:
* Age \> = 18 years
* MD, DO, NP, or PA
* 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.
* Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit
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, and other staff (e.g., service line or nursing leaders).
* Employed for at least one month at the practice.
* Able to speak and reads English, because the HN-STAR tool is only available in English at this time.
Stakeholder Inclusion Criteria:
* Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study.
* Age \>= 18
* MD, DO, NP, or PA
Primary Care Provider
* Age ≥18 years.
* Diagnosis of primary or locoregionally recurrent head and neck squamous cell carcinoma, specifically oral cavity, larynx, oropharynx, hypopharynx, and unknown squamous cell carcinoma primary.
* Completed chemotherapy and/or radiation therapy with curative intent for head and neck squamous cell carcinoma ≤ 24 months prior to designated clinician visit.
* Deemed free of disease at last assessment.
* Cognitively and physically able to complete study survey per local NCORP site staff discretion.
* Scheduled for a clinic visit with a provider who has agreed to participate in this 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 telephone or videoconference using smartphone, tablet, or computer) or 2) at the clinic to complete study assessments on a clinic tablet or computer.
Survivor Inclusion Criteria:
* Age \> = 18 years
* MD, DO, NP, or PA
* 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.
* Willing to complete study-specific trainings and incorporate HN-STAR or provide usual care in a routine follow-up care visit
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, and other staff (e.g., service line or nursing leaders).
* Employed for at least one month at the practice.
* Able to speak and reads English, because the HN-STAR tool is only available in English at this time.
Stakeholder Inclusion Criteria:
* Provides primary care (general preventative care) to a survivor enrolled in the HN-STAR study.
* Age \>= 18
* MD, DO, NP, or PA
Primary Care Provider
Gender
All
Gender Based
false
Keywords
Survivorship
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04208490
Org Class
Other
Org Full Name
Wake Forest University Health Sciences
Org Study Id
IRB00060694
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Implementation and Effectiveness Trial of HN-STAR
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change in HNC-Specific QOL
Outcome Time Frame
Baseline & 1 year
Secondary Ids
Secondary Id
NCI-2019-03600
Secondary Id
WF-1805CD
Secondary Id
5UG1CA189824
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline & 1 year
Outcome Measure
Change in QoL
Outcome Description
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.
Outcome Time Frame
Baseline & 1 year
Outcome Measure
Change in QoL
Outcome Description
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.
Outcome Time Frame
Baseline & 1 year
Outcome Measure
Change symptom burden
Outcome Description
Measured using PRO-CTCAE items for relevant symptoms.
Outcome Time Frame
Baseline & 1 year
Outcome Measure
Change in symptom burden
Outcome Description
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.
Outcome Time Frame
Baseline & 1 year
Outcome Measure
Change in pain
Outcome Description
Measured using Patient Activation Measure Short Form. PAM score ranges from 0 to 100, with higher score meaning higher level of activation.
Outcome Time Frame
Baseline & 1 year
Outcome Measure
Change in patient activation
Outcome Description
Measured using the CAHPS® Cancer Care Survey.
Outcome Time Frame
Baseline & 1 year
Outcome Measure
Change in perceived quality of cancer care
Outcome Description
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.
Outcome Time Frame
These variables will be derived from the medical record during the year following the initial visit.
Outcome Measure
Adherence and surveillance of guideline concordant care
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rafi Kabarriti
Investigator Email
RKABARRI@MONTEFIORE.ORG