NCT02984033WithdrawnNot Applicable
Quality of Life and Psychological Evaluation of Patients Affected by Head and Neck Cancer Treated With Curative Intent: Multicentric Prospective Study
Michele Tedeschi1 site in 1 countryStarted: November 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Quality of life and psychological effetcs evaluated by patient reported outcome (PRO)
Study Overview
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
Detailed Description
The multicentric prospective trial is to evaluate the quality of life and psychological effects in patients with head and neck tumor treated by curative intent radiation therapy. The treatment consists in a conventionally fractionated Intensity Modulated Radiotherapy (IMRT) or until 2.2 Gy per fraction with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Quality of life and psychological effetcs evaluated by patient reported outcome (PRO)
Time Frame: 18 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Michele Tedeschi
Medical Doctor
Istituto Clinico Humanitas
Study Sites (1)
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