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Telemedicine Nurse-Led Intervention for Rural Cancer Survivors (CARING)

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: NCT04267627
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
Pamela DeGuzman, University of Virginia

Brief Summary:
This study will evaluate the impact, cost-effectiveness, and patient perspectives of Comprehensive Assistance: Rural Intervention, Nursing, and Guidance (CARING), a nurse-led supportive care protocol delivered using telemedicine videoconferencing aimed at reducing unmet needs in a rural head and neck cancer population. Specific aims: 1) Test the efficacy of CARING, delivered with and without telemedicine, compared to a control group. 2) Conduct a cost-effectiveness analysis of a nurse-led telemedicine visit. 3) Evaluate patient perceptions of a telemedicine intervention. Design: We will use a three-arm randomized control design to determine the efficacy of CARING delivered face-to-face, vs. CARING over telemedicine, vs. usual care. Costs will be determine for incremental cost effectiveness analysis, with quality of life years as the effectiveness variable. Patient perceptions will be evaluated qualitatively using the Practical, Robust Implementation and Sustainability Model (PRISM), designed to evaluate translation of research into practice and quantitatively using the Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ). Sample: We will enroll 450 head and neck cancer survivors of any stage who have completed treatment within the last 6 weeks (address over sampling of rural). Procedures: Following randomization, those in the intervention arm will either receive the nurse-led intervention in a clinic setting or over telemedicine videoconferencing 6 weeks following their in-person, end of treatment medical visit. Assessments at baseline, 6 weeks following the intervention, and 6 months following the intervention will document unmet needs using the Short Form Survivorship Unmet Needs (SF-SUNS) and quality of life using the Functional Assessment of Cancer Therapies- Head and Neck (FACT-HN) and the TSUQ and PRISM-guided questionnaires immediately following intervention. Health utilization costs at the societal and health system levels will be collected from the electronic medical record and patient interviews.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasm Survivorship Behavioral: Comprehensive Assistance: Rural Interventions, Nursing, and Guidance (CARING) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three-arm trial evaluating CARING delivered over telemedicine vs. CARING delivered face-to-face vs. usual care
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Nurse-Led Telemedicine Videoconferencing Intervention to Improve Access to Supportive Cancer Survivorship Care for Rural Virginians
Estimated Study Start Date : December 31, 2020
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
No intervention.
Experimental: CARING with telemedicine
Patients will receive the nurse-led supportive care intervention over telemedicine videoconferencing from home or from a satellite telemedicine site in Virginia.
Behavioral: Comprehensive Assistance: Rural Interventions, Nursing, and Guidance (CARING)
Cancer-related distress will be assessed using the NCCN Distress Thermometer amended to include HNC-specific areas of distress. For those participants experiencing high rates of distress, the nurse will provide targeted distress education. Education for participants exhibiting successful distress self-management, or with distress that has already resolved will focus on reinforcing surveillance and health promotion information contained in the Survivorship Care Plan. When indicated, the nurse will discuss potential referrals to support services with the patient, and they will decide jointly which referrals will be beneficial. Following the visits, the nurse will make agreed upon referrals using existing cancer center pathways, documenting these in the medical record. The nurse will follow-up with the patient via telephone 6 weeks following the telemedicine visit to determine uptake of the referral, documenting all referral information in the electronic medical record.

Experimental: CARING face-to-face
Patients will receive the nurse-led supportive care intervention in person.
Behavioral: Comprehensive Assistance: Rural Interventions, Nursing, and Guidance (CARING)
Cancer-related distress will be assessed using the NCCN Distress Thermometer amended to include HNC-specific areas of distress. For those participants experiencing high rates of distress, the nurse will provide targeted distress education. Education for participants exhibiting successful distress self-management, or with distress that has already resolved will focus on reinforcing surveillance and health promotion information contained in the Survivorship Care Plan. When indicated, the nurse will discuss potential referrals to support services with the patient, and they will decide jointly which referrals will be beneficial. Following the visits, the nurse will make agreed upon referrals using existing cancer center pathways, documenting these in the medical record. The nurse will follow-up with the patient via telephone 6 weeks following the telemedicine visit to determine uptake of the referral, documenting all referral information in the electronic medical record.




Primary Outcome Measures :
  1. Number and type of Unmet Needs [ Time Frame: baseline ]
    Survivorship Unmet Needs Survey- Short Form. 30 question scale with 0-4 rating for each item. Overall scores range 0-120. Lower scores indicated fewer unmet needs.

  2. Number and type of Unmet Needs [ Time Frame: 6 weeks post intervention ]
    Survivorship Unmet Needs Survey- Short Form. 30 question scale with 0-4 rating for each item. Overall scores range 0-120. Lower scores indicated fewer unmet needs.

  3. Number and type of Unmet Needs [ Time Frame: 6 monthspost intervention ]
    Survivorship Unmet Needs Survey- Short Form. 30 question scale with 0-4 rating for each item. Overall scores range 0-120. Lower scores indicated fewer unmet needs.

  4. Quality of Life rating [ Time Frame: baseline ]
    Functional Assessment of Cancer Therapies- Head and Neck (FACT-HN). Quality of life scale with 4 sub-scales and 12 items each related specifically to head and neck cancer quality of life. The Physical Health scale has 7 items, each rated 0-4. Scores range from 0-28 with a lower score indicating better quality of life. The Social Well Being scale has 7 items, each rated 0-4. Scores range from 0-28 with a higher score indicating better quality of life. The Emotional Well Being scale has 6 items, each rated 0-4. Scores range from 0-24 with a lower score indicating better quality of life. The Functional scale has 7 items, each rated 0-4. Scores range from 0-28 with a higher score indicating better quality of life. The remaining 12 items are all scored as 0-4 each, range for each item 0-4 with higher or lower score indicating better quality life depending on each individual item.

  5. Quality of Life rating [ Time Frame: 6 weeks post intervention ]
    Functional Assessment of Cancer Therapies- Head and Neck (FACT-HN). Quality of life scale with 4 sub-scales and 12 items each related specifically to head and neck cancer quality of life. The Physical Health scale has 7 items, each rated 0-4. Scores range from 0-28 with a lower score indicating better quality of life. The Social Well Being scale has 7 items, each rated 0-4. Scores range from 0-28 with a higher score indicating better quality of life. The Emotional Well Being scale has 6 items, each rated 0-4. Scores range from 0-24 with a lower score indicating better quality of life. The Functional scale has 7 items, each rated 0-4. Scores range from 0-28 with a higher score indicating better quality of life. The remaining 12 items are all scored as 0-4 each, range for each item 0-4 with higher or lower score indicating better quality life depending on each individual item.

  6. Quality of Life rating [ Time Frame: 6 months post intervention ]
    Functional Assessment of Cancer Therapies- Head and Neck (FACT-HN). Quality of life scale with 4 sub-scales and 12 items each related specifically to head and neck cancer quality of life. The Physical Health scale has 7 items, each rated 0-4. Scores range from 0-28 with a lower score indicating better quality of life. The Social Well Being scale has 7 items, each rated 0-4. Scores range from 0-28 with a higher score indicating better quality of life. The Emotional Well Being scale has 6 items, each rated 0-4. Scores range from 0-24 with a lower score indicating better quality of life. The Functional scale has 7 items, each rated 0-4. Scores range from 0-28 with a higher score indicating better quality of life. The remaining 12 items are all scored as 0-4 each, range for each item 0-4 with higher or lower score indicating better quality life depending on each individual item.


Secondary Outcome Measures :
  1. telemedicine usefulness and satisfaction [ Time Frame: within one week of intervention ]
    Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ). The TSUQ has 2 domains and a total of 21 items, the Video Visits domain (11 items) and the Use and Impact domain (10 items) each measured on a scale 1-5. The range of scores for Video Visits domain is 11-55 with a higher score indicating more satisfaction with video visits, and the Use and for the Use and Impact domain is 10-50, with higher scores indicating more usefulness to impact health outcomes.



Information from the National Library of Medicine

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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

Inclusion Criteria:

  • Diagnosis of Head and Neck Cancer
  • Anticipated to be within 3 months of end of treatment
  • At least 18 years old

Exclusion Criteria:

-


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): NCT04267627


Contacts
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Contact: Pamela DeGuzman, PhD 4344668327 pambakerdeguzman@gmail.com
Contact: Ivora Hinton, PhD 4349823291 idh2r@virginia.edu

Sponsors and Collaborators
University of Virginia
University of Arizona
Investigators
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Principal Investigator: Pamela B DeGuzman, PhD University of Virginia

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Responsible Party: Pamela DeGuzman, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT04267627    
Other Study ID Numbers: 20991
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Pamela DeGuzman, University of Virginia:
Telemedicine
Cancer Survivorship
Rural Health Disparities
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms