Change in Symptom Clusters in HNC Patients
22. listopadu 2017 aktualizováno: Chia-Chin Lin, Taipei Medical University
Change in Symptom Clusters in HNC Patients Undergoing Postoperative Radiotherapy: A Longitudinal Study
Head and neck cancer (HNC) is the sixth most common malignancy worldwide, causing more than 379,000 deaths in 2015 notwithstanding the breakthrough in cancer screening and medical treatment.
The primary treatment for HNC is a combination of surgery and radiotherapy, either delivered preoperatively or postoperatively.
Although these treatments, especially the postoperative radiotherapy can greatly improve the survival of patients, they still have to pay a high price for numerous symptoms induced by radiation.
On the other hand, research on symptoms clusters is an emerging field in oncology which aims to understand the complexity of multiple symptoms experienced by cancer patients.
A thorough understanding of symptom clusters help informs the development of comprehensive care plans which target a group of symptoms that is likely to coexist, thus easing the total symptom burden in cancer patients.To date, there has been a paucity of evidence regarding symptom clusters of HNC.
To address the gap in existing literature, this study described the symptom clusters among HNC patients who were treated with surgery with a combination of postoperative radiotherapy.
In addition, a longitudinal approach was employed to examine the change in symptom clusters throughout the treatment course.
Přehled studie
Typ studie
Pozorovací
Zápis (Aktuální)
100
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Head and neck cancer patients undergoing postoperative radiotherapy
Popis
Inclusion Criteria:
- Newly diagnosed with HNC,
- Aged older than 18 years,
- Without receiving any radiotherapy prior to surgery,
- No cognitive impairment and able to communicate in Mandarin or Taiwanese
Exclusion Criteria:
- Undergoing any concurrent treatment for cancer.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Patients with head and neck cancer
No intervention was provided.
The patients were only asked to complete a set of questionnaire at baseline, and week 1, 2, 3, 4, 5 and 6 after starting of postoperative radiotherapy.
|
Patients were asked to complete a questionnaire at baseline, and week 1, 2, 3, 4, 5 and 6 after starting of radiotherapy.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Časové okno: 6 months after radiotherapy
|
The Taiwanese version of the MD Anderson Symptom Inventory is designed to assess the severity of 13 symptoms that are most commonly reported by patients undergoing cancer treatment.
The symptoms include dry mouth, fatigue, sleep disturbance, pain, drowsiness, lack of appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, distress and sadness.
Participants in this study were asked to rate the severity of these symptoms on a 11-point Likert scale, with "0" representing "not present "and "10" representing "as bad as you can imagine".
The item scores of 1 - 4, 5 - 6 and 7 - 10 are considered as mild, moderate and severe, respectively.
The composite score can be obtained by averaging the 13 item scores.
|
6 months after radiotherapy
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Časové okno: baseline
|
The Taiwanese version of the MD Anderson Symptom Inventory is designed to assess the severity of 13 symptoms that are most commonly reported by patients undergoing cancer treatment.
The symptoms include dry mouth, fatigue, sleep disturbance, pain, drowsiness, lack of appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, distress and sadness.
Participants in this study were asked to rate the severity of these symptoms on a 11-point Likert scale, with "0" representing "not present "and "10" representing "as bad as you can imagine".
The item scores of 1 - 4, 5 - 6 and 7 - 10 are considered as mild, moderate and severe, respectively.
The composite score can be obtained by averaging the 13 item scores.
|
baseline
|
|
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Časové okno: 1 month after radiotherapy
|
The Taiwanese version of the MD Anderson Symptom Inventory is designed to assess the severity of 13 symptoms that are most commonly reported by patients undergoing cancer treatment.
The symptoms include dry mouth, fatigue, sleep disturbance, pain, drowsiness, lack of appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, distress and sadness.
Participants in this study were asked to rate the severity of these symptoms on a 11-point Likert scale, with "0" representing "not present "and "10" representing "as bad as you can imagine".
The item scores of 1 - 4, 5 - 6 and 7 - 10 are considered as mild, moderate and severe, respectively.
The composite score can be obtained by averaging the 13 item scores.
|
1 month after radiotherapy
|
|
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Časové okno: 2 months after radiotherapy
|
The Taiwanese version of the MD Anderson Symptom Inventory is designed to assess the severity of 13 symptoms that are most commonly reported by patients undergoing cancer treatment.
The symptoms include dry mouth, fatigue, sleep disturbance, pain, drowsiness, lack of appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, distress and sadness.
Participants in this study were asked to rate the severity of these symptoms on a 11-point Likert scale, with "0" representing "not present "and "10" representing "as bad as you can imagine".
The item scores of 1 - 4, 5 - 6 and 7 - 10 are considered as mild, moderate and severe, respectively.
The composite score can be obtained by averaging the 13 item scores.
|
2 months after radiotherapy
|
|
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Časové okno: 3 months after radiotherapy
|
The Taiwanese version of the MD Anderson Symptom Inventory is designed to assess the severity of 13 symptoms that are most commonly reported by patients undergoing cancer treatment.
The symptoms include dry mouth, fatigue, sleep disturbance, pain, drowsiness, lack of appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, distress and sadness.
Participants in this study were asked to rate the severity of these symptoms on a 11-point Likert scale, with "0" representing "not present "and "10" representing "as bad as you can imagine".
The item scores of 1 - 4, 5 - 6 and 7 - 10 are considered as mild, moderate and severe, respectively.
The composite score can be obtained by averaging the 13 item scores.
|
3 months after radiotherapy
|
|
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Časové okno: 4 months after radiotherapy
|
The Taiwanese version of the MD Anderson Symptom Inventory is designed to assess the severity of 13 symptoms that are most commonly reported by patients undergoing cancer treatment.
The symptoms include dry mouth, fatigue, sleep disturbance, pain, drowsiness, lack of appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, distress and sadness.
Participants in this study were asked to rate the severity of these symptoms on a 11-point Likert scale, with "0" representing "not present "and "10" representing "as bad as you can imagine".
The item scores of 1 - 4, 5 - 6 and 7 - 10 are considered as mild, moderate and severe, respectively.
The composite score can be obtained by averaging the 13 item scores.
|
4 months after radiotherapy
|
|
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Časové okno: 5 months after radiotherapy
|
The Taiwanese version of the MD Anderson Symptom Inventory is designed to assess the severity of 13 symptoms that are most commonly reported by patients undergoing cancer treatment.
The symptoms include dry mouth, fatigue, sleep disturbance, pain, drowsiness, lack of appetite, nausea, vomiting, shortness of breath, numbness, difficulty remembering, distress and sadness.
Participants in this study were asked to rate the severity of these symptoms on a 11-point Likert scale, with "0" representing "not present "and "10" representing "as bad as you can imagine".
The item scores of 1 - 4, 5 - 6 and 7 - 10 are considered as mild, moderate and severe, respectively.
The composite score can be obtained by averaging the 13 item scores.
|
5 months after radiotherapy
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. ledna 2015
Primární dokončení (Aktuální)
1. ledna 2017
Dokončení studie (Aktuální)
1. ledna 2017
Termíny zápisu do studia
První předloženo
20. listopadu 2017
První předloženo, které splnilo kritéria kontroly kvality
22. listopadu 2017
První zveřejněno (Aktuální)
29. listopadu 2017
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. listopadu 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. listopadu 2017
Naposledy ověřeno
1. listopadu 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HKU_2
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ne
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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