- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03356093
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
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.
Sponsori
Opintojen ennätyspäivät
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Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Torstai 1. tammikuuta 2015
Ensisijainen valmistuminen (Todellinen)
Sunnuntai 1. tammikuuta 2017
Opintojen valmistuminen (Todellinen)
Sunnuntai 1. tammikuuta 2017
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Maanantai 20. marraskuuta 2017
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 22. marraskuuta 2017
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 29. marraskuuta 2017
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Keskiviikko 29. marraskuuta 2017
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 22. marraskuuta 2017
Viimeksi vahvistettu
Keskiviikko 1. marraskuuta 2017
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