Survivorship Clinical Trial
— CARINGOfficial 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.
Status | Not yet recruiting |
Enrollment | 450 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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: - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | University of Arizona |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | telemedicine usefulness and satisfaction | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Active, not recruiting |
NCT05796518 -
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT06015009 -
Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers
|
N/A | |
Active, not recruiting |
NCT05837169 -
Randomized Study to Evaluate an Intervention Based on Mindfulness to Reduce Anxiety in Breast Cancer Survivors
|
N/A | |
Completed |
NCT04601090 -
Survival Rates and Longterm Outcomes After COVID-19
|
||
Completed |
NCT04066218 -
Sexual Function Screening in Childhood Cancer Survivors
|
||
Not yet recruiting |
NCT05020561 -
Life After Breast Cancer - Impact of a Life Coach
|
N/A | |
Recruiting |
NCT05863702 -
Staying Healthy With Follow-up Care: A Mobile Chatbot Feasibility Study for AYA Cancer Survivors
|
N/A | |
Recruiting |
NCT04898855 -
Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors
|
N/A | |
Recruiting |
NCT05574127 -
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
|
Phase 2 | |
Active, not recruiting |
NCT04918082 -
Assessment of Quality of Life and Treatment Times for Patients With Invasive Type Breast Cancer in Martinique
|
||
Completed |
NCT04596865 -
Recurrence After Whipple's (RAW) Study
|
||
Recruiting |
NCT05611307 -
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
|
||
Completed |
NCT04758026 -
H&N Cancer; Survivorship and Late Effects
|
||
Recruiting |
NCT04547634 -
Telerehabilitation in Oncology Patients
|
N/A | |
Recruiting |
NCT04014309 -
Accessible Cancer Care to Enable Support for Survivors Programme
|
N/A | |
Completed |
NCT05610982 -
A Yoga Program for Adults Diagnosed With Gynecologic Cancer
|
N/A | |
Completed |
NCT05121259 -
Feasibility and Acceptability of an Web-based Physical Activity Program, for Those Diagnosed With Lung Cancer.
|
N/A |