Palliative and Oncology Care Intervention: Symptom COACH

Study Overview
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Brief Summary
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The investigators propose to conduct the first pilot trial of a collaborative palliative and oncology care intervention for HNC patients receiving CRT to assess the feasibility and acceptability of the intervention. The intervention will incorporate weekly palliative care visits into standard oncology care targeting coping, mood, and symptom management.

Official Title
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A Collaborative Palliative and Oncology Care Intervention to Improve Symptoms and Coping During Treatment for Head and Neck Cancer

Conditions
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Cancer of Head and Neck

Intervention / Treatment
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* Other: Evidenced-based symptom management and coping intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (≥18 years) with a diagnosis of HNC for which they are undergoing CRT receiving all oncology care at Fox Chase Cancer Center (FCCC) able to speak and read in English or with assistance from an interpreter Exclusion Criteria: patients with prior history of HNC for which they underwent CRT patients with uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease which the treating clinician believes prohibits informed consent or participation in the study patients enrolled on other supportive care intervention trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative palliative and oncology care<br> | Other: Evidenced-based symptom management and coping intervention<br>* The intervention visits will focus on coping and the following symptoms prevalent during CRT: (1) pain and mucositis, (2) nausea, (3) constipation, (4) fatigue, (5) sleep disturbances, (6) xerostomia, (7) thick mucus, and (8) depression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who comply for acceptability of a collaborative palliative and oncology care intervention for patients with HNC receiving CRT | The intervention will be considered feasible if >50% of patients agree to enroll on the trial and if > 70% of the participants have at least half of the scheduled palliative care visits | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with coping strategies longitudinally in relation to symptom burden, QOL, mood, and health care utilization | This exploratory aim will provide preliminary data on associations of coping with patient outcomes to power a larger trial. We will specifically examine whether approach-oriented coping is associated with lower symptom burden, higher QOL and mood, and reduced health care utilization (e.g fewer hospitalizations, fewer treatment breaks or reductions in chemotherapy dose intensity) | 11 weeks |