Telemedicine Nurse-Led Intervention for Rural Cancer Survivors
CARING
A Nurse-Led Telemedicine Videoconferencing Intervention to Improve Access to Supportive Cancer Survivorship Care for Rural Virginians
1 other identifier
interventional
450
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedStudy Start
First participant enrolled
December 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedFebruary 17, 2020
February 1, 2020
4 years
February 5, 2020
February 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Number and type of Unmet Needs
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.
baseline
Number and type of Unmet Needs
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.
6 weeks post intervention
Number and type of Unmet Needs
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.
6 monthspost intervention
Quality of Life rating
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.
baseline
Quality of Life rating
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 weeks post intervention
Quality of Life rating
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 months post intervention
Secondary Outcomes (1)
telemedicine usefulness and satisfaction
within one week of intervention
Study Arms (3)
Usual Care
NO INTERVENTIONNo intervention.
CARING with telemedicine
EXPERIMENTALPatients will receive the nurse-led supportive care intervention over telemedicine videoconferencing from home or from a satellite telemedicine site in Virginia.
CARING face-to-face
EXPERIMENTALPatients will receive the nurse-led supportive care intervention in person.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of Head and Neck Cancer
- Anticipated to be within 3 months of end of treatment
- At least 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Virginialead
- University of Arizonacollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela B DeGuzman, PhD
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 5, 2020
First Posted
February 13, 2020
Study Start
December 31, 2020
Primary Completion
January 1, 2025
Study Completion
January 1, 2026
Last Updated
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share