Change in Symptom Clusters in HNC Patients
22 november 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Werkelijk)
100
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Head and neck cancer patients undergoing postoperative radiotherapy
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2015
Primaire voltooiing (Werkelijk)
1 januari 2017
Studie voltooiing (Werkelijk)
1 januari 2017
Studieregistratiedata
Eerst ingediend
20 november 2017
Eerst ingediend dat voldeed aan de QC-criteria
22 november 2017
Eerst geplaatst (Werkelijk)
29 november 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 november 2017
Laatste update ingediend die voldeed aan QC-criteria
22 november 2017
Laatst geverifieerd
1 november 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HKU_2
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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