Clinical trial NCT03356093: Change in Symptom Clusters in HNC Patients
Official title: Change in Symptom Clusters in HNC Patients Undergoing Postoperative Radiotherapy: A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms, Head and Neck
Keywords: head and neck cancer, symptom cluster, change, radiotherapy
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and neck cancer patients undergoing postoperative radiotherapy

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
timeFrame: 6 months after radiotherapy
Secondary outcomes:
measure: treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
timeFrame: baseline
measure: treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
timeFrame: 1 month after radiotherapy
measure: treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
timeFrame: 2 months after radiotherapy
measure: treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
timeFrame: 3 months after radiotherapy
measure: treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
timeFrame: 4 months after radiotherapy
measure: treatment-related symptoms of head and neck cancer patients with post-operative radiotherapy assessed by the Taiwanese version of the MD Anderson Symptom Inventory
timeFrame: 5 months after radiotherapy
Other outcomes:
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