Telemedicine Nurse-Led Intervention for Rural Cancer Survivors
Telemedicine Nurse-Led Intervention for Rural Cancer Survivors
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.
Once cancer treatment has concluded (a phase called "extended survivorship") some cancer
 survivors continue to experience physical and psychosocial morbidities, and short-term and
 late effects of treatment, all of which can impact survivors' mental health, quality of life,
 and occupational and social functioning. Continued deficits in post-treatment health and
 function are termed survivorship unmet needs. Survivors of head and neck cancer (HNC; defined
 as cancer of the oral cavity, pharynx, larynx, sinuses, nasal cavity, and salivary glands)
 suffer numerous and often life-altering unmet needs including lingering pain, altered speech
 and eating, and facial disfigurement. Few interventions exist to connect HNC survivors with
 resources to address physical and psychosocial sequelae, and accordingly HNC survivors have
 high unmet needs. Rural survivors are even less likely to have their post-treatment needs
 met. The University of Virginia (UVa) Emily Couric Clinical Cancer Center (EC4) serves a
 largely rural catchment area where patients travel up to 6 hours to receive treatment. The
 EC4 offer a range of supportive care resources to assist HNC survivors during treatment, but
 once treatment is over, rural survivors are less likely to know of, let alone make use of
 these resources. Using resources of the well-established UVa Center for Telehealth (CFT) our
 intervention connects rural survivors with a nurse-led supportive care visit using
 telemedicine videoconferencing.

 Preliminary data from Comprehensive Assistance: Rural Intervention, Nursing, and Guidance
 (CARING), a nurse-led, protocol-driven visit delivered over telemedicine videoconferencing
 suggests that supplementing medical follow-up with a face-to-face nursing visit over
 telemedicine works to overcome access barriers for rural survivors, and may reduce unmet
 needs, all without the need for the patient to travel to the EC4. Importantly, because of the
 extensive network and capabilities of the CFT we are able to offer the intervention either in
 patient's own home or through one of UVa's active telemedicine sites throughout the state.
 During the pilot intervention 35% (7/20) of participants were successfully referred to and
 connected with a supportive care provider. Pilot data suggests that a nurse-led proactive
 unmet needs intervention may overcome the stigma associated with asking for or accepting
 psychosocial help among rural residents, which can further complicate the provision of
 supportive care to this population.

 Identifying the optimal approach to address rural survivors' unmet needs, we next need to
 determine if the nurse protocol or the telemedicine modality (or both) are driving
 intervention success. Health systems and policy makers considering adopting this model of
 care need understand to incremental costs and cost-effectiveness of providing a nurse-led
 protocol delivered via telemedicine. Rural and older populations may experience more
 difficulties adopting health technology; thus we need to determine patients' perspectives on
 the use and usefulness of the intervention.

 Aim 1. Test the efficacy of CARING, delivered with and without telemedicine, compared to a
 control group. Hypothesis 1: HNC survivors who receive the CARING intervention will have a
 significantly larger reduction in unmet needs. Preliminary data revealed that HNC survivors
 of later cancer stage, longer distance to care, and receiving a home intervention, were more
 likely to accept a referral to address their unmet needs. We will determine the impact of
 those factors, as well as rurality, home broadband access, SES, race, ethnicity, and sex, on
 reduction in survivorship unmet needs. Hypothesis 2: Rural HNC survivors will be more likely
 to attend a home-based telemedicine intervention than an in-person visit. We will compare
 attendance rates of rural HNC survivors between those who receive a telemedicine home-based
 intervention and an in-person visit.

 Aim 2. Conduct a cost-effectiveness analysis of a nurse-led telemedicine visit. We will
 calculate the ratio of incremental costs of delivering the intervention compared to the
 improvement in quality of life. Compare the relative costs of survivorship care delivered 1)
 with or without the CARING telemedicine intervention and 2) with or without the CARING
 intervention (without telemedicine) from both societal and health system perspectives.
 Analyze cost-effectiveness models for early and late stage cancers, and rural/non-rural
 survivors.

 Aim 3. Evaluate patient perceptions of a telemedicine intervention. Hypothesis 3:
 Participants will report both the nurse interaction and minimizing travel as benefits of the
 intervention and technology use a barrier. Survey participants to determine intervention
 patient-centeredness, barriers, seamlessness of transition between program elements, access,
 and burden of participation in the intervention.
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:

 -