Survivorship Clinical Trial
Official title:
A Nurse-Led Telemedicine Videoconferencing Intervention to Improve Access to Supportive Cancer Survivorship Care for Rural Virginians
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.
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