Head and Neck Carcinoma, Radiotherapy Side Effects
Conditions
Keywords
Head and Neck Carcinoma, Multidisciplinary Team, Radiotherapy interruption, Supportive Care
Brief summary
Radiotherapy is one of the main treatments for head and neck Carcinoma. The incidence of radiotherapy-related adverse events is greater than 90%, and severe adverse events may lead to the interruption of radiotherapy. The management of nutritional, psychological, and rehabilitative issues in patients undergoing radiotherapy for head and neck cancer presents unique clinical challenges. We aimed to evaluate the efficacy of the SHINE-MDT (Supportive Holistic Interventions by Nurses and Experts via Multidisciplinary Team) in reducing radiotherapy interruptions and improving patients' quality of life (QoL) compared with usual care.
Interventions
BEHAVIORALWhole-Course Multidisciplinary Care Intervention
On the basis of standard treatment, all patients were evaluated by senior practice nurses in the Department of Oncology in person at the time of enrollment (before radiotherapy) and once every week during radiotherapy, and once in person/over the phone at 1, 2, 3, and 6 months after radiotherapy.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients had pathologically confirmed malignant head and neck tumors without distant metastasis. 2. Patient age ≥18 years; 3. Patients were scheduled to undergo either postoperative adjuvant radiotherapy or radical radiotherapy, with or without concurrent chemotherapy. 4. Baseline ECOG (Eastern Cooperative Oncology Group) score 0-2; 5. Good cognitive and reading skills, able to complete the questionnaire survey.
Exclusion criteria
1. Presence of other malignant tumors aside from head and neck malignancies; 2. A history of prior head and neck radiotherapy; 3. Mental illness or cognitive impairments; 4. Uncontrolled systemic diseases that could significantly affect their QoL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiotherapy interruption rate | 5 days | Interruption of radiotherapy was defined as the actual end date of radiotherapy minus the expected end date at least 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score (EORTC QLQ C30) | Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment | Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30) |
| Quality of life score QLQ-HN35 | Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment | Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35 |
| Nutritional status (NRS 2002, PG-SGA) | Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment | Nutritional status was calculated according to Nutrition Risk Screening 2002 and Patient-Generated Subjective Global Assessment。 |
| Psychological status (DT, PHQ-9, HADS) | Weekly during radiotherapy and the first month post-treatment, and at 2, 3, and 6 months post-treatment | Psychological status was calculated according to Distress Thermometer (DT), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9) |
Countries
China
Outcome results
None listed