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This study will evaluate whether a new patient navigation intervention can decrease delays starting post-operative radiation therapy after surgery for white and African-American head and neck cancer patients.
This study will evaluate the feasibility, acceptability, preliminary clinical impact, and preliminary behavioral impact of NDURE (Navigation for Disparities and Untimely Radiation thErapy), our multi-level, theory-based navigation intervention to improve timely, equitable post-operative radiation treatment (PORT) among Head and Neck Cancer (HNC) patients. We hypothesize that NDURE will be feasible, acceptable, improve the timeliness of PORT for white and African American (AA) HNC patients and decrease disparities in delay between the two groups by improving system-, interpersonal-, and individual-level health behavior constructs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Navigation | Experimental | 45 patients (15 African American, 30 white) will interact with a patient navigator three times over three months to identify and address barriers before they cause breakdowns in care delivery, employing resources, education, and care coordination from the day of surgery until post-operative radiation treatment begins. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Navigation | Other | NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients With a Delay Starting Post-Operative Radiation Treatment | Percent of patients who start PORT >6 weeks after surgery. Initiation of postoperative PORT > 6 weeks after surgery is defined as more than 42 calendar days from the time of the definitive surgical resection to the initiation of radiation therapy. In situations in which the surgical management of the primary tumor and the neck are staged (i.e. occur on two different calendar days), the date of the surgery for the primary tumor will be used. In situations in which an additional surgical resection is required (e.g. re-resection of positive margins to clear residual disease), the date of the earlier (i.e. attempted definitive) surgical procedure will be used to determine the target start date for PORT. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Difference in PORT Delay Between White and AA HNC Patients. | The difference in the rate of initiation of PORT > 6 weeks after surgery between white and AA HNC patients (i.e., the difference in the percentage of white and AA participants who initiate PORT >6 weeks after surgery) | 6 weeks |
| Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients |
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In order to be eligible to participate in this study, an individual must meet all of the following criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Graboyes, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26313895 | Background | Ohlstein JF, Brody-Camp S, Friedman S, Levy JM, Buell JF, Friedlander P. Initial Experience of a Patient Navigation Model for Head and Neck Cancer. JAMA Otolaryngol Head Neck Surg. 2015 Sep;141(9):804-9. doi: 10.1001/jamaoto.2015.1467. | |
| 28727137 | Background | Cramer JD, Speedy SE, Ferris RL, Rademaker AW, Patel UA, Samant S. National evaluation of multidisciplinary quality metrics for head and neck cancer. Cancer. 2017 Nov 15;123(22):4372-4381. doi: 10.1002/cncr.30902. Epub 2017 Jul 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NDURE (Patient Navigation) | NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | NDURE (Patient Navigation) | NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Patients With a Delay Starting Post-Operative Radiation Treatment | Percent of patients who start PORT >6 weeks after surgery. Initiation of postoperative PORT > 6 weeks after surgery is defined as more than 42 calendar days from the time of the definitive surgical resection to the initiation of radiation therapy. In situations in which the surgical management of the primary tumor and the neck are staged (i.e. occur on two different calendar days), the date of the surgery for the primary tumor will be used. In situations in which an additional surgical resection is required (e.g. re-resection of positive margins to clear residual disease), the date of the earlier (i.e. attempted definitive) surgical procedure will be used to determine the target start date for PORT. | ITT | Posted | Count of Participants | Participants | 6 weeks |
|
from baseline to initiation of postoperative radiation therapy
the specific period of time is variable in this study, with end-of study defined as the initiation of postoperative radiation therapy (or 12 weeks if PORT is never started)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Navigation | Patient Navigation: NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evan Graboyes (PI) | Medical University of South Carolina | 843-792-0719 | graboyes@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 18, 2019 | Apr 20, 2020 | ICF_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2019 | Nov 21, 2020 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
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|
Median difference in time-to-PORT, defined as the difference in number of days from surgery to initiation of PORT between white and AA HNC patients |
| 12 weeks |
| Time-to-PORT | Days between surgery and the start of PORT is defined as the time, in days, between the date of definitive surgical resection to the initiation of radiation therapy. All of the criteria used to adjudicate the date of the definitive surgical procedure described for the primary outcome measure will be applied to this measure. | 12 weeks |
| Percent of Patients With Pre-Surgical Radiation Consultation | Percent of patients with pre-surgical radiation consultation as defined as the attendance by the patient at a consultation with a radiation oncologist (at MUSC or elsewhere) prior to surgery to discuss RT in the definitive or adjuvant setting. | 12 weeks |
| Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions | Percent of patients with on-time dental extractions, defined as the extraction of teeth prior to discharge from the index hospitalization for the definitive surgical procedure. Patients who are edentulous are not evaluable for this measure. | 12 weeks |
| Percent of Patients Surgery to Pathology Reports </= 7 Days | Surgery to Pathology Report \ | 12 weeks |
| Percent of Patients With Referral to PORT Within 10 Days of Surgery | Percent of patients with surgery to PORT referral \ | 12 weeks |
| Percent of Patients With RT Consult Within 10 Days of RT Referral | Percent of patients with RT Referral to Consult \ | 12 weeks |
| Percent of Patients With Initiation of RT Within 21 Days of Consultation | Percent of patients with RT Consult to Initiation \ | 12 weeks |
| Barriers Resolved | The number of barriers identified by the navigator that are resolved during the NDURE intervention, as determined by the navigator log. | 12 weeks |
| Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study | The Communication and Attitudinal Self-Efficacy Scale for Cancer-12 (CASE-cancer) measures self-efficacy within the context of productive communication and positive attitude for cancer patients. It is a psychometrically sound tool that may provide new information on important mediating factors of cancer care. The response scale ranges from 1 to 4 points (1= strongly disagree, 2=slightly disagree, 3=slightly agree, 4=strongly disagree). The twelve question scale is divided into 3 domains with 4 questions each. Scores from these subscales are added to compute a total score ranging from 12-48. Higher values represent a more positive attitude. | 12 weeks |
| Barriers Unresolved | The number of barriers identified by the navigator that are not resolved during the NDURE intervention, as determined by the navigator log. | 12 weeks |
| Percent of Eligible Participants Who Accrue to NDURE | Percent of eligible participants who accrue to NDURE, defined as a participant who meets all inclusion criteria and no exclusion criteria | 13 months |
| Percentage of Enrolled Participants Who Complete NDURE | Percentage of enrolled participants who complete NDURE, defined as eligible patients who complete the baseline assessment, at least two NDURE intervention sessions, and the final follow-up assessment | 13 months |
| Navigation Session Completion | The number of NDURE navigation sessions completed by a participant | 12 weeks |
| Navigator Caseload | The number of simultaneous cases (on-trial participants) being navigated by the NDURE navigator | 13 months |
| Navigator Time Allocation (Direct) | The time (in minutes), that the NDURE navigator spends directly interacting with the patient to identify and address barriers to timely, equitable postoperative radiation therapy | 12 weeks |
| Navigator Time Allocation (Indirect) | The time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient | 12 weeks |
| Satisfaction With the Interpersonal Relationship With the Navigator Scale Score | The PSN-I measures the satisfaction with the interpersonal relationship with the patient navigator. The PSN-I score is defined as the total score of this 9-item scale. The total score ranges from 9 (minimum) to 45 (maximum); higher scores represent a better outcome (greater satisfaction with the interpersonal relationship with the navigator). | 12 weeks |
| Satisfaction With Logistical Aspects of Navigation Scale Score | This 26-item scale measures the satisfaction of the logistical aspects of PN. The total score of the measure ranges from 0 (minimum) to 78 (maximum); higher scores represent a better outcome (greater satisfaction with the logistical aspects of navigation). | 12 weeks |
| Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study | Care Transition Measure-15 (CTM-15) is a validated, psychometrically sound 15-item, unidimensional measure of care transitions across the healthcare system that is consistent with the concept of patient-centeredness and useful from an organization perspective for the purpose of performance measurement and quality improvement. Items are rated on a 4-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (4). The CTM-15 score is calculated as the mean score (the summed score from each question divided by the total number of questions) with a linear transformation to 100. Scores range from 0-100; higher scores reflect more care integration and better care transitions. | 12 weeks |
| Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study | The ISEL-12 is a validated, 12-item assessment of three subscales (appraisal, belonging, and tangible) that has been used to assess support in prior PN studies. Items are rated on a 4-point Likert scale from 'Definitely False' (1) to 'Definitely True' (4). The total score is calculated by summing scores across all items (with reverse coding for items 1, 2, 7, 8, 11, 12). Scores range from 12-48. Higher scores indicate more support. | 12 weeks |
| Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study | The Perceived Susceptibility Questionnaire is modified version of a validated 3-item perceived susceptibility subscale for mammography screening to assess perceived susceptibility for delays starting PORT after HNC surgery. Items are rated on a 5-point Likert scale. Scores range from 3-15 with higher scores indicating higher perceived susceptibility. | 12 weeks |
| Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study | The IPQ-R consequences subscale is easily modifiable to asses disease-specific perceived severity. The IPQ-R is a validated assessment of a patient's self-representation of the health consequences of their illness. There are 6 Items; each is rated using a 5-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (5). The score is calculated by summing across all items (with reverse coding for item 3). Scores range from 5 to 30. Higher scores indicate a greater degree of perceived severity of the illness. | 12 weeks |
| Change in Perceived Barriers Score From Baseline to End-of-study | The Perceived Barriers Questionnaire is a self-report measure of the presence/absence of pre-specified barriers to cancer care (yes/no). The questionnaire has been used extensively to assess perceived barriers in prior PN studies. Scores range from 0-29; higher scores reflect a greater number of barriers to care | 12 weeks |
| 12560449 | Background | Huang J, Barbera L, Brouwers M, Browman G, Mackillop WJ. Does delay in starting treatment affect the outcomes of radiotherapy? A systematic review. J Clin Oncol. 2003 Feb 1;21(3):555-63. doi: 10.1200/JCO.2003.04.171. |
| 28841234 | Background | Graboyes EM, Garrett-Mayer E, Ellis MA, Sharma AK, Wahlquist AE, Lentsch EJ, Nussenbaum B, Day TA. Effect of time to initiation of postoperative radiation therapy on survival in surgically managed head and neck cancer. Cancer. 2017 Dec 15;123(24):4841-4850. doi: 10.1002/cncr.30939. Epub 2017 Aug 25. |
| 28241092 | Background | Graboyes EM, Garrett-Mayer E, Sharma AK, Lentsch EJ, Day TA. Adherence to National Comprehensive Cancer Network guidelines for time to initiation of postoperative radiation therapy for patients with head and neck cancer. Cancer. 2017 Jul 15;123(14):2651-2660. doi: 10.1002/cncr.30651. Epub 2017 Feb 27. |
| 29631478 | Background | Divi V, Chen MM, Hara W, Shah D, Narvasa K, Segura Smith A, Kelley J, Rosenthal EL, Porter J. Reducing the Time from Surgery to Adjuvant Radiation Therapy: An Institutional Quality Improvement Project. Otolaryngol Head Neck Surg. 2018 Jul;159(1):158-165. doi: 10.1177/0194599818768254. Epub 2018 Apr 10. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percent Difference in PORT Delay Between White and AA HNC Patients. | The difference in the rate of initiation of PORT > 6 weeks after surgery between white and AA HNC patients (i.e., the difference in the percentage of white and AA participants who initiate PORT >6 weeks after surgery) | ITT | Posted | Number | percentage of participants | 6 weeks |
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| Secondary | Median Difference in Time-to-PORT, in Days, Between White and African American HNC Patients | Median difference in time-to-PORT, defined as the difference in number of days from surgery to initiation of PORT between white and AA HNC patients | ITT | Posted | Median | Standard Deviation | days | 12 weeks |
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| Secondary | Time-to-PORT | Days between surgery and the start of PORT is defined as the time, in days, between the date of definitive surgical resection to the initiation of radiation therapy. All of the criteria used to adjudicate the date of the definitive surgical procedure described for the primary outcome measure will be applied to this measure. | ITT | Posted | Median | 95% Confidence Interval | days | 12 weeks |
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| Secondary | Percent of Patients With Pre-Surgical Radiation Consultation | Percent of patients with pre-surgical radiation consultation as defined as the attendance by the patient at a consultation with a radiation oncologist (at MUSC or elsewhere) prior to surgery to discuss RT in the definitive or adjuvant setting. | ITT | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Percent of Patients With On-time Pre-Radiation Therapy Dental Extractions | Percent of patients with on-time dental extractions, defined as the extraction of teeth prior to discharge from the index hospitalization for the definitive surgical procedure. Patients who are edentulous are not evaluable for this measure. | ITT- modified (the endpoint is only evaluable for dentate patients and 3 patients were edentulous and thus not evaluable for the endpoint) | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Percent of Patients Surgery to Pathology Reports </= 7 Days | Surgery to Pathology Report \ | ITT | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Percent of Patients With Referral to PORT Within 10 Days of Surgery | Percent of patients with surgery to PORT referral \ | ITT | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Percent of Patients With RT Consult Within 10 Days of RT Referral | Percent of patients with RT Referral to Consult \ | ITT | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Percent of Patients With Initiation of RT Within 21 Days of Consultation | Percent of patients with RT Consult to Initiation \ | ITT | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Barriers Resolved | The number of barriers identified by the navigator that are resolved during the NDURE intervention, as determined by the navigator log. | ITT | Posted | Mean | Standard Deviation | barriers | 12 weeks |
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| Secondary | Change in Self-Efficacy in Cancer Care Score From Baseline to End-of-study | The Communication and Attitudinal Self-Efficacy Scale for Cancer-12 (CASE-cancer) measures self-efficacy within the context of productive communication and positive attitude for cancer patients. It is a psychometrically sound tool that may provide new information on important mediating factors of cancer care. The response scale ranges from 1 to 4 points (1= strongly disagree, 2=slightly disagree, 3=slightly agree, 4=strongly disagree). The twelve question scale is divided into 3 domains with 4 questions each. Scores from these subscales are added to compute a total score ranging from 12-48. Higher values represent a more positive attitude. | ITT- 3 participants did not complete the questionnaire | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| Secondary | Barriers Unresolved | The number of barriers identified by the navigator that are not resolved during the NDURE intervention, as determined by the navigator log. | ITT | Posted | Mean | Standard Deviation | unresolved barriers | 12 weeks |
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| Secondary | Percent of Eligible Participants Who Accrue to NDURE | Percent of eligible participants who accrue to NDURE, defined as a participant who meets all inclusion criteria and no exclusion criteria | eligible patients | Posted | Number | percentage of eligible participants | 13 months |
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| Secondary | Percentage of Enrolled Participants Who Complete NDURE | Percentage of enrolled participants who complete NDURE, defined as eligible patients who complete the baseline assessment, at least two NDURE intervention sessions, and the final follow-up assessment | ITT | Posted | Number | percentage of enrolled participants | 13 months |
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| Secondary | Navigation Session Completion | The number of NDURE navigation sessions completed by a participant | ITT | Posted | Mean | Standard Deviation | NDURE sessions | 12 weeks |
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| Secondary | Navigator Caseload | The number of simultaneous cases (on-trial participants) being navigated by the NDURE navigator | ITT | Posted | Mean | Full Range | NDURE participants | 13 months |
|
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| Secondary | Navigator Time Allocation (Direct) | The time (in minutes), that the NDURE navigator spends directly interacting with the patient to identify and address barriers to timely, equitable postoperative radiation therapy | ITT | Posted | Mean | Full Range | minutes | 12 weeks |
|
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| Secondary | Navigator Time Allocation (Indirect) | The time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient | ITT | Posted | Mean | Full Range | minutes | 12 weeks |
|
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| Secondary | Satisfaction With the Interpersonal Relationship With the Navigator Scale Score | The PSN-I measures the satisfaction with the interpersonal relationship with the patient navigator. The PSN-I score is defined as the total score of this 9-item scale. The total score ranges from 9 (minimum) to 45 (maximum); higher scores represent a better outcome (greater satisfaction with the interpersonal relationship with the navigator). | ITT- two participants failed to return the end of study questionnaire | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
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| Secondary | Satisfaction With Logistical Aspects of Navigation Scale Score | This 26-item scale measures the satisfaction of the logistical aspects of PN. The total score of the measure ranges from 0 (minimum) to 78 (maximum); higher scores represent a better outcome (greater satisfaction with the logistical aspects of navigation). | ITT- two participants failed to turn in end-of study questionnaires | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
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| Secondary | Change in Care Transition Measure-15 (CTM-15) Score From Baseline to End-of-study | Care Transition Measure-15 (CTM-15) is a validated, psychometrically sound 15-item, unidimensional measure of care transitions across the healthcare system that is consistent with the concept of patient-centeredness and useful from an organization perspective for the purpose of performance measurement and quality improvement. Items are rated on a 4-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (4). The CTM-15 score is calculated as the mean score (the summed score from each question divided by the total number of questions) with a linear transformation to 100. Scores range from 0-100; higher scores reflect more care integration and better care transitions. | ITT- 3 did not complete the questionnaire | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
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| Secondary | Change in Interpersonal Support Evaluation List-12 (ISEL-12) Score From Baseline to End-of-study | The ISEL-12 is a validated, 12-item assessment of three subscales (appraisal, belonging, and tangible) that has been used to assess support in prior PN studies. Items are rated on a 4-point Likert scale from 'Definitely False' (1) to 'Definitely True' (4). The total score is calculated by summing scores across all items (with reverse coding for items 1, 2, 7, 8, 11, 12). Scores range from 12-48. Higher scores indicate more support. | ITT- 1 did not complete baseline questionnaire and 2 different participants did not complete end of study questionnaire leaving 7 evaluable paired pre-post data points | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
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| Secondary | Change in Perceived Susceptibility Questionnaire Score From Baseline to End-of-study | The Perceived Susceptibility Questionnaire is modified version of a validated 3-item perceived susceptibility subscale for mammography screening to assess perceived susceptibility for delays starting PORT after HNC surgery. Items are rated on a 5-point Likert scale. Scores range from 3-15 with higher scores indicating higher perceived susceptibility. | 4 participants did not complete a post questionnaire | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
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| Secondary | Change in Illness Perception Questionnaire-Revised (IPQ-R) Consequences Subscale Score From Baseline to End-of-study | The IPQ-R consequences subscale is easily modifiable to asses disease-specific perceived severity. The IPQ-R is a validated assessment of a patient's self-representation of the health consequences of their illness. There are 6 Items; each is rated using a 5-point Likert scale from 'Strongly Disagree' (1) to 'Strongly Agree' (5). The score is calculated by summing across all items (with reverse coding for item 3). Scores range from 5 to 30. Higher scores indicate a greater degree of perceived severity of the illness. | ITT- 3 participants did not complete the questionnaire | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
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| Secondary | Change in Perceived Barriers Score From Baseline to End-of-study | The Perceived Barriers Questionnaire is a self-report measure of the presence/absence of pre-specified barriers to cancer care (yes/no). The questionnaire has been used extensively to assess perceived barriers in prior PN studies. Scores range from 0-29; higher scores reflect a greater number of barriers to care | ITT- 3 did not complete post-treatment questionnaire | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
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| D006298 | Health Services Administration |