Quality of Life and Psycological Evaluation of Patients Affected by Head and Neck Cancer

NCT02984033 | Withdrawn DMC

• 1 other identifier: 1642
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The prospective trial is to describe the quality of life and psychological effects in patients with head and neck tumor receiving curative intent treatment

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality of life and psychological effetcs evaluated by patient reported outcome (PRO)

  18 months

Study Arms (1)

Head and Neck patients

Patients affected by squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) with no metastasis

Radiation: Head and Neck patients

Interventions

Head and Neck patients RADIATION

Treatment consists of Intensity Modulated Radiation Therapy (until 2.2 Gy) with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.

Head and Neck patients

Eligibility Criteria

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

Study Population

Patients affected by head and neck tumor

You may qualify if:

• Squamous cell carcinoma of head and neck (oral cavity, larynx, pharynx and hypopharynx) in non-metastatic staging;
• curative intent treatment (radiation therapy associated or not to chemotherapy; surgery associated or not to post-operative radiotherapy and chemotherapy);
• performance status \< 2;
• age ≥ 18 years;
• good knowledge of italian language;
• written informed consent

Sponsors & Collaborators

• Michele Tedeschi: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Study Officials

• Ciro Franzese, MD

  Humanitas Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)