Melanoma Clinical Trial
Official title:
Randomized Clinical Trial of Telenursing for Monitoring Supportive Care Needs in Patients With Lung Cancer and Melanoma Candidates for the First Prescription of Targeted Therapies
ingle-center, randomized clinical trial (RCT) with low intervention level (Telenursing), for the monitoring of patients affected by lung cancer and melanoma who are candidates for first prescription with Targeted Therapies. The study population will consist of patients suffering from lung cancer and melanoma. The objective of the study will be to evaluate the effectiveness of a Telenursing nursing intervention, comparing the mean score of the total SCNs scale (Supportive Care Needs) after one month of treatment in the treatment arm and in the control arm. Enrolled patients will then be randomized into two treatment arms: - Arm 1 (Control Group): current clinical practice - Arm 2 (Experimental group): Telenursing nursing intervention.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - aged between 18 and 75; - patients suffering from lung cancer and melanoma candidates for the first prescription with Targeted Therapies in exclusive treatment; - patients able to understand, speak Italian and join the study by signing of paper informed consent; - possibility of accessing and using the information technologies adopted in trial through a PC/tablet and personal internet connection; - patients willing to comply with study procedures. Exclusion Criteria: - patients not suffering from lung cancer or melanoma; - patients already treated or currently being treated with Targeted Therapies, or other treatment (chemotherapy and/or radiotherapy and/or exclusive palliative care); - patients with cognitive problems, psychiatric disorders and poor compliance who could interfere with study participation. |
Country | Name | City | State |
---|---|---|---|
Italy | "Regina Elena" National Cancer Institute | Rome |
Lead Sponsor | Collaborator |
---|---|
Regina Elena Cancer Institute |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Telenursing nursing intervention | Effectiveness of a Telenursing nursing intervention we have chosen compare the average score after one month of treatment of the total SCN scale (Need for supportive care) in the treatment arm and control arm by administering a form for monitoring support therapy needs (Ebrahimabadi et al., 2021; Zeneli et al., 2016) | 12 months | |
Secondary | Measure of quality of life | Assess quality of life through administration of the SF-36 QoL sheet (Apolone & Mosconi, 1998; Ware & Sherbourne, 1992) | 12 months | |
Secondary | Patient satisfaction | The degree of patient satisfaction by administering the form relating to satisfaction and usability of the SUS system - System Usability Scale (Borsci et al., 2009; Brooke, 1996) | 12 months | |
Secondary | Supportive Care Needs | Therapeutic adherence and the incidence and degree of severity of all Adverse Events (grade 1, 2, 3 and 4 according to the Common, Terminology Criteria for Adverse Event, CTCAE) by administering a form for monitoring Supportive Care Needs (Ebrahimabadi et al., 2021; Zeneli et al., 2016) sheet for measuring adverse events: Likert scale 1-5 - filled in by clinicians and by research nurses during the monthly in-person visit (CTCAE) | 12 months | |
Secondary | Patient Reported Outcomes, PROs | Explore the differences between the Adverse Events reported by healthcare personnel and those reported by patients (Patient Reported Outcomes, PROs) | 12 months |
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