In Portugal, approximately 2,424 new cases of head and neck cancer are diagnosed each year, of which 60% are already at an advanced stage, presenting with intense pain and dysphagia (difficulty swallowing). There is also marked social isolation due to communication difficulties, economic hardship, and facial disfigurement (altered facial appearance). As a result, patients frequently face challenges in accessing specialised palliative care services, encountering delays, fragmentation, or a complete absence of such care.
The i-CARE-HN study is the solution: investigators aim to integrate outpatient palliative care with oncological treatment -namely chemoradiotherapy -at an earlier stage of the disease-when it is still limited to the throat and neck region, without metastasis (spread to other organs). This means multidisciplinary support from the outset of oncological treatment - symptom control, psychological support, and quality of life - without delaying the cure. It is like giving the patient a 'shield' against suffering, enabling them to complete treatment more efficiently.
In the i-CARE-HN study, early palliative care aims to better manage patients' symptoms (such as pain, difficulty speaking, swallowing, breathing, dry mouth, loss of appetite, and anxiety), to clarify doubts, to support therapeutic decisions, and to strengthen communication between the patient and the team, without replacing the primary oncological treatment. Rather than waiting for symptoms to worsen before seeking help, this support will be provided throughout treatment with chemotherapy and radiotherapy. Through this simultaneous integration of outpatient palliative care into oncological treatment, investigators hope to improve patients' symptoms and quality of life, as well as clinical outcomes: fewer treatment interruptions, improved treatment tolerability, fewer emergency hospitalisations, and greater overall survival. Investigators will want to know how patients are feeling throughout the process, and to that end, will invite them to complete a survey at several points during the study. Responses to the questionnaires are critical to enabling the medical team to rapidly identify which participating patients present with the most significant symptoms and the greatest risk of complications.
This study plans to recruit 64 patients aged 18 years or older, with a recent diagnosis of locally advanced, inoperable cancer, being followed on an outpatient basis at the IPO de Coimbra, IPO do Porto, and ULS de Coimbra, who will be invited to participate in the study. Should the patient agree to participate, some baseline data will be collected, and patients will subsequently be randomly assigned to one of two groups: one group will receive isolated chemoradiotherapy (standard treatment: cisplatin 100 mg/m² every 3 weeks- days 1, 22, and 49- and daily radiotherapy 70 Gy in 35 fractions over 7 weeks) and the other group will receive chemoradiotherapy alongside palliative care, on an outpatient basis (access to palliative care consultations). Patients randomised to the standard treatment group (chemoradiotherapy without a structured early palliative care intervention) will not have palliative care appointments systematically scheduled. However, should a referral to palliative care be requested, the patient may be directed to that clinical department.
Diagnosis of locally advanced (unresectable) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, larynx, and hypopharynx, staged according to the TNM AJCC 8th edition, proposed at a multidisciplinary team (MDT) meeting for definitive chemoradiotherapy (CRT) on an outpatient basis;
Age ≥18 years;
ECOG performance status 0-2;
Adequate organ function: haemoglobin ≥9 g/dL; neutrophils ≥1.5×10⁹/L; platelets ≥100×10⁹/L; creatinine ≤1.5×ULN; bilirubin, AST, ALT, LDH ≤1.5×ULN;
ECOG performance status 3-4;
Previous follow-up by specialised palliative care;
Primary tumours of the nasopharynx, oesophagus, lip, or salivary glands;
Metastatic head and neck cancer (oral cavity, oropharynx, larynx, and hypopharynx);
Parallel
Early palliative care integration
BehavioralIn the intervention arm, the first palliative care consultation must be scheduled within 28 days of signing the informed consent form and must coincide with the day of the first cycle of cisplatin chemotherapy and radiotherapy. The second consultation will take place between the 3rd and 7th week of treatment (D+22 to D+49). The third consultation will be conducted after completion of CRT (7th week) through to the 9th week. The fourth consultation will take place 12 weeks after study enrolment (primary outcome). Two long-term follow-up assessments (every 6 months) may be conducted either in person or remotely. Additional consultations will be at the discretion of the patient, the primary caregiver, the oncologist, and the palliative care physician.
ESAS-R score #1 (cross comparison)
Patient-reported evaluation of 9 relevant symptoms (pain, fatigue, somnolence, nausea, loss of appetite, dyspnea, depression, anxiety and well-being) and an open section for reporting "other problems", using a scale from 0 (no symptom) to 10 (maximum intensity symptom) for every symptom. The final score is obtained by summing all symptom evaluations (ranging from 0-100). Aim: To determine the impact of early integration of outpatient palliative care alongside chemoradiotherapy on the symptom burden of patients. It will be assessed in both study groups (control and intervention). Note: ESAS-R tool includes a final body diagram allowing participants to indicate the location of pain.
ESAS-R score #2 (cross/longitudinal comparison)
Patient-reported evaluation of 9 relevant symptoms (pain, fatigue, somnolence, nausea, loss of appetite, dyspnea, depression, anxiety and well-being) and an open section for reporting "other problems", using a scale from 0 (no symptom) to 10 (maximum intensity symptom) for every symptom. The final score is obtained by summing all symptom evaluations (ranging from 0-100). Aim: To evaluate the pragmatic clinical impact of early integration of palliative care with chemoradiotherapy on symptom improvement in patients- Reduction of =/\>1 point on the ESAS-R scale. It will be assessed in both study groups (control and intervention). Note: ESAS-R tool includes a final body diagram allowing participants to indicate the location of pain.
Hospitalisation occurrence Type 1 (CTC-AE =>3)
Number of emergency events classified as CTC-AE =\>3 (quantitative; No. of events). Common Terminology Criteria for Adverse Events (CTC-AE) is used for the standardised characterisation of adverse event severity during oncological treatment, enabling toxicity grading on a scale from 1 to 5: 1- Mild symptoms (better outcome); 2: Moderate, needing minimal intervention; 3- Severe, non-life-threatening, requiring intervention; 4- Life-threatening, requiring urgent intervention; 5: Death related to the adverse event (worse outcome). Aim: To evaluate the effect of early integration of palliative care on the risk of hospitalisation, healthcare resource utilisation, and the need for emergency interventions. It will be assessed in both study groups (control and intervention).
Hospitalisation occurrence Type 2 (CTC-AE =>3)
Number of inpatient care events (No. of events). Aim: To evaluate the effect of early integration of palliative care on the risk of hospitalisation, healthcare resource utilisation, and the need for emergency interventions. It will be assessed in both study groups (control and intervention).
Hospitalisation occurrence Type 3 (CTC-AE =>3)
Number of extra consultations (No. of events). Aim: To evaluate the effect of early integration of palliative care on the risk of hospitalisation, healthcare resource utilisation, and the need for emergency interventions. It will be assessed in both study groups (control and intervention).
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Portuguese Oncology Institute, Coimbra
Lead sponsor
Unidade Local de Saúde de Coimbra, EPE
Collaborator
Instituto Portugues de Oncologia, Francisco Gentil, Porto
Collaborator
Hospital do Divino Espírito Santo de Ponta Delgada
Collaborator
University of Coimbra
Collaborator
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