Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT (F4T)
2021년 7월 31일 업데이트: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Acute and Long-term Impact of Cancer Treatment on Quality-of-life, Physical and Cognitive Function of Head and Neck Cancer Patients
Head and Neck Squamous Cell Carcinoma (HNSCC) is the 6th most common cancer.
Most cases are diagnosed in locally advanced stages, with treatment involving multimodal approach with combinations of radiotherapy, surgery and chemotherapy.
The aggressive nature of HNSCCs and treatment modalities are associated with important acute and late toxicities that often promote temporary or definitive treatment interruption and may compromised the capability to tolerate subsequent treatments.
Thus, the aim of this study is to analyze the acute and long-term impact of cancer treatment on quality of life, physical and cognitive function of HNSCC patients diagnosed with a locally advanced disease.
연구 개요
상태
종료됨
정황
상세 설명
Potential cases will be identified at the multidisciplinary head and neck group meeting.
If the case meets eligibility an informed consent will be presented to the patient.
Interested participants will be scheduled for baseline assessment before the beginning of treatment (M0).
At the end of CRT patients will be submitted to a second assessment (M1).
Follow-up assessments will occur 16th to 18th weeks after the treatment is completed (M2).
Patients proposed to surgery or induction chemotherapy will also be submitted to an additional assessment before the beginning of CRT (Mc / Mic).
연구 유형
관찰
등록 (실제)
21
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Vila Nova De Gaia, 포르투갈
- Centro Hospitalar Vila Nova de Gaia / Espinho
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
해당 없음
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Eligible patients had to have more than 18 years, diagnosed with stage III to IVB HNSCC and proposed for primary treatment with curative intent - surgery or induction chemotherapy before chemoradiotherapy (CRT) or CRT alone.
Exclusion criteria was: 1) synchronous tumors or other comorbidities with associated uncontrolled symptoms; 2) inability to provide informed consent; 3) expected inability to fulfil the propose schedule and follow-up.
설명
Inclusion Criteria:
- Patients older than 18 years.
- Diagnosis of locally advanced head and neck cancer (oral cavity, oropharynx, hypopharynx, larynx), stage III-IVB.
- Proposed for primary treatment with curative intent - surgery or induction chemotherapy before chemoradiotherapy (CRT) or CRT alone.
Exclusion Criteria:
- Synchronous tumors or other comorbidities with associated uncontrolled symptoms.
- Inability to provide informed consent.
- Expected inability to fulfil the propose schedule and follow-up.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of life (acute)
기간: Change of global quality of life score from baseline to the end of treatment
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Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
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Change of global quality of life score from baseline to the end of treatment
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Quality of life (long-term)
기간: Change of global quality of life score from baseline to 4 months after the treatment is completed
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Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
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Change of global quality of life score from baseline to 4 months after the treatment is completed
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Fatigue (acute)
기간: Change of fatigue score from baseline to the end of treatment
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Fatigue score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents high level of symptomatology / problems)
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Change of fatigue score from baseline to the end of treatment
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Fatigue (long-term)
기간: Change of fatigue score from baseline to 4 months after the treatment is completed
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Fatigue score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents high level of symptomatology / problems)
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Change of fatigue score from baseline to 4 months after the treatment is completed
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Social functioning (acute)
기간: Change of body mass index from baseline to the end of treatment
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Social functioning score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
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Change of body mass index from baseline to the end of treatment
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Social functioning (long-term)
기간: Change of body mass index from baseline to 4 months after the treatment is completed
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Social functioning score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
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Change of body mass index from baseline to 4 months after the treatment is completed
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Body composition (acute)
기간: Change of body mass index from baseline to the end of treatment
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Body mass index, evaluated by bioelectrical impedance (BMI kg/m^2).
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Change of body mass index from baseline to the end of treatment
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|
Body composition (long-term)
기간: Change of body mass index from baseline to 4 months after the treatment is completed
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Body mass index, evaluated by bioelectrical impedance (BMI kg/m^2).
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Change of body mass index from baseline to 4 months after the treatment is completed
|
|
Cognitive function (acute)
기간: Change of MoCA score from baseline to the end of treatment
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Evaluated by the Montreal Cognitive Assessment and the Functional Assessment of Cancer Therapy-Cognitive (MoCA score range between 0 and 30, a score of 26 or over is considered to be normal).
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Change of MoCA score from baseline to the end of treatment
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Cognitive function (long-term)
기간: Change of MoCA score from baseline to 4 months after the treatment is completed
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Evaluated by the Montreal Cognitive Assessment and the Functional Assessment of Cancer Therapy-Cognitive (MoCA score range between 0 and 30, a score of 26 or over is considered to be normal).
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Change of MoCA score from baseline to 4 months after the treatment is completed
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Dysphagia (acute)
기간: Change of EAT-10 score from baseline to the end of treatment
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Severity of dysphagia assessed by Eating Assessment Tool (EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of dysphagia)
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Change of EAT-10 score from baseline to the end of treatment
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Dysphagia (long-term)
기간: Change of EAT-10 score from baseline to 4 months after the treatment is completed
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Severity of dysphagia assessed by Eating Assessment Tool (EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of dysphagia)
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Change of EAT-10 score from baseline to 4 months after the treatment is completed
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Dysphagia (acute)
기간: Change of FOIS score from baseline to the end of treatment
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Severity of dysphagia assessed by Functional Oral Intake Scale (FOIS ranges from 1 to 7)
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Change of FOIS score from baseline to the end of treatment
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Dysphagia (long-term)
기간: Change of FOIS score from baseline to 4 months after the treatment is completed
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Severity of dysphagia assessed by Functional Oral Intake Scale (FOIS ranges from 1 to 7)
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Change of FOIS score from baseline to 4 months after the treatment is completed
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Nutritional status (acute)
기간: Change of PG-SGA total score from baseline to the end of treatment
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Evaluated by the Patient-Generated Subjective Global Assessment (PG-SGA range from 0-35 with a higher score reflecting a greater risk of malnutrition).
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Change of PG-SGA total score from baseline to the end of treatment
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Nutritional status (long-term)
기간: Change of PG-SGA total score from baseline to 4 months after the treatment is completed
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Evaluated by the Patient-Generated Subjective Global Assessment (PG-SGA range from 0-35 with a higher score reflecting a greater risk of malnutrition).
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Change of PG-SGA total score from baseline to 4 months after the treatment is completed
|
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Handgrip maximal isometric muscle strength (acute)
기간: Change of muscle strength from baseline to the end of treatment
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Measured with manual dynamometers (Kgf).
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Change of muscle strength from baseline to the end of treatment
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Handgrip maximal isometric muscle strength (long-term)
기간: Change of muscle strength from baseline to 4 months after the treatment is completed
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Measured with manual dynamometers (Kgf).
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Change of muscle strength from baseline to 4 months after the treatment is completed
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Quadriceps maximal isometric muscle strength (acute)
기간: Change of muscle strength from baseline to the end of treatment
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Measured with manual dynamometers (Kgf).
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Change of muscle strength from baseline to the end of treatment
|
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Quadriceps maximal isometric muscle strength (long-term)
기간: Change of muscle strength score from baseline to 4 months after the treatment is completed
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Measured with manual dynamometers (Kgf).
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Change of muscle strength score from baseline to 4 months after the treatment is completed
|
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Sit-to-stand test (acute)
기간: Change of repetitions from baseline to the end of treatment
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Sit-to-stand test during 30 seconds
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Change of repetitions from baseline to the end of treatment
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Sit-to-stand test (long-term)
기간: Change of repetitions from baseline to 4 months after the treatment is completed
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Sit-to-stand test during 30 seconds
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Change of repetitions from baseline to 4 months after the treatment is completed
|
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Physical function (acute)
기간: Change of distance from baseline to the end of treatment
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6 minutes walking test (meters).
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Change of distance from baseline to the end of treatment
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Physical function (long-term)
기간: Change of distance from baseline to 4 months after the treatment is completed
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6 minutes walking test (meters)
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Change of distance from baseline to 4 months after the treatment is completed
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Progression free survival
기간: 2 years follow-up
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Defined as the time from the beginning of treatment to the date of first progression or death (whichever occurs first) and will be censored at last follow-up date if the patient does not have the event.
A progression (local, regional or distant) will be assumed accordingly to the imaging evaluation and/or histopathologic confirmation.
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2 years follow-up
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Overall survival
기간: 2 years follow-up
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Defined as the time from the beginning of treatment to the date of death from any cause, for patients who do not die, it will be censored at their last follow-up date.
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2 years follow-up
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Capability of tolerating subsequent treatments
기간: 2 years follow-up
|
Defined as the proportion of patients that complete the first cycle of the first line palliative chemotherapy after a documented progression (considering all patients with a formal indication).
|
2 years follow-up
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Inês Leão, MD, Centro Hospitalar Vila Nova de Gaia / Espinho
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 6월 1일
기본 완료 (실제)
2020년 3월 3일
연구 완료 (실제)
2020년 3월 3일
연구 등록 날짜
최초 제출
2021년 4월 25일
QC 기준을 충족하는 최초 제출
2021년 7월 31일
처음 게시됨 (실제)
2021년 8월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 7월 31일
마지막으로 확인됨
2021년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 102/2019
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아니
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