NICSO National Study: Physician - Nurse Monitoring Project About Oncological Adverse Events

NCT04726020 | Completed DMC

• 1 other identifier: NICSO
• Study Type: interventional
• Target: 645
• Locations: 1 country
• Sites: 1

Brief Summary

The lacking adherence to guidelines on prevention and treatment of different chemotherapy, targeted therapy, and immunotherapy induced toxicities is the reason why there are a potential incidence and duration increase of adverse events. It is clear the need of a collateral effect early recognition for an adequate clinical management and for limiting their intensity and duration. There is the need for a multicentre randomized clinical study in specific therapeutical settings (chemotherapy, target therapy, immunotherapy) assessing the impact of planned and ongoing patients' monitoring by nurses. The NICSO study foresees patient enrolment that is in adjuvant chemotherapy for breast cancer, colon, and lung; that is in chemotherapy or immunotherapy or with targeted therapy. Moreover, this working assesses toxicity differences (but also of QoL, number of PS access or non-planned medical examinations, number of hospitalization and number of recovery days) in patients that carried out a toxicity prevention and cure standard therapy in comparison with the standard assessment to which is added a periodic nursing phone intervention.

Conditions

Cancer

Keywords

immunotherapy; targeted therapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Assessment of the number of days that have passed with at least a toxicity grade >= 3

  Assessment of the number of days that have passed with at least a toxicity grade \>= 3. The assessed toxicities have been chosen for their clinical relevance and for their higher danger to reduce patients' treatment adherence, invalidating therapy benefits.

  6 months

Secondary Outcomes (4)

• low grade toxicity (grade 1 and 2) incidence and duration

  6 months

• number of ER admissions and number of non-planned medical examinations

  6 months

• number of hospitalization and its duration because of treatment toxicity

  6 months

• QoL (Quality of Life) assessment

  6 months

Other Outcomes (1)

• Changes in treatment dose intensity

  6 months

Study Arms (2)

Intensive monitoring

EXPERIMENTAL

Intensive phone monitoring of drug adverse events

Other: Intensive monitoring

Standard monitoring

PLACEBO COMPARATOR

Standard monitoring of drug adverse events

Other: Standard monitoring

Interventions

Intensive monitoring OTHER

periodic and planned monitoring nurse intervention with phone call

Intensive monitoring

Standard monitoring OTHER

standard monitoring of adverse event reaction

Standard monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>18;
• Solid cancer histological diagnosis on treatment with one of the listed medicines, defined by treatment type:
• Adjuvant chemotherapy:
• anthracyclines and cyclophosphamide ± taxanes (breast cancer)
• oxaliplatin e fluoropyrimidine (colon cancer)
• combination of platin or its derivate (lung cancer)
• First line oral target therapy:
• sunitinib, pazopanib (renal cancer)
• gefitinib, erlotinib,afatinib, crizotinib (lung cancer)
• vemurafenib ± comimetinib, dabrafenib±trametinib (Melanoma)
• everolimus ± exemestane (breast cancer)
• vandetanib o lenvatinib (thyroid cancer)
• vismodegib (skin basal cell carcinoma)
• imatinib (GIST)
• Immunotherapy:

You may not qualify if:

• Presence of cerebral symptomatic metastasis;
• Presence of neurological or psychiatric disease or other conditions that stop the protocol procedure compliance;
• Participation in other clinical studies

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Paolo Bossi, MD

  Italian Network of Supportive Care in Cancer

  STUDY CHAIR

• Andrea Antonuzzo, MD

  Italian Network of Supportive Care in Cancer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two comparison groups: an intervention group (intensive phone monitoring of adverse event reactions) compared with a placebo group (standard monitoring)

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: January 27, 2021
• Study Start: March 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: January 31, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Locations

IT (1)