- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04267627
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pamela DeGuzman, PhD
- Phone Number: 4344668327
- Email: pambakerdeguzman@gmail.com
Study Contact Backup
- Name: Ivora Hinton, PhD
- Phone Number: 4349823291
- Email: idh2r@virginia.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
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.
|
6 weeks post intervention
|
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.
|
6 monthspost intervention
|
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.
|
baseline
|
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 weeks post intervention
|
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.
|
6 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within one week of intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pamela B DeGuzman, PhD, University of Virginia
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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