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NCT04267627: CARING
Telemedicine Nurse-Led Intervention for Rural Cancer Survivors
NA trial testing Comprehensive Assistance: Rural Interventions, Nursing, and Guidance (CARING) in Head and Neck Neoplasm in 450 participants. Status unknown.
1 January 2025
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 450 |
| Start date | 31 December 2020 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2026 |
Drugs / interventions tested
- Comprehensive Assistance: Rural Interventions, Nursing, and Guidance (CARING)
Conditions studied
- Head and Neck Neoplasm — all drugs for Head and Neck Neoplasm →
- Survivorship — all drugs for Survivorship →
Sponsor
University of Virginia
Who can join
18 and older, any sex, with Head and Neck Neoplasm or Survivorship. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04267627
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Head and Neck Neoplasm
Currently open trials in the same condition.
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- NCT06356272 — Oropharynx (OPX) Biomarker Trial · recruiting
- NCT04005521 — Randomized Study Regarding Preventive Jaw- and Swallowing Intervention for Patients With Head and Neck Cancer · NA · active not recruiting
- NCT03840421 — GP Vs PF As Induction Chemotherapy Combined with CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma · Phase 3 · active not recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04267627 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Virginia
- Last refreshed: 17 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04267627.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing