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Change in Symptom Clusters in HNC Patients

keskiviikko 22. marraskuuta 2017 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Interventio / Hoito

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

100

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi
  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

Head and neck cancer patients undergoing postoperative radiotherapy

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Havaintomallit: Kohortti
  • Aikanäkymät: Tulevaisuuden

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Ensimmäinen Lähetetty (Todellinen)

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Viimeksi vahvistettu

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Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

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