Palliative and Oncology Care Intervention: Symptom COACH

Not Applicable

• Conditions: Cancer of Head and Neck
• Interventions: Other: Evidenced-based symptom management and coping intervention

• Registration Number: NCT03760471
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-07
• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Primary Completion: 2019-11-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

1. adult patients (≥18 years) with a diagnosis of HNC for which they are undergoing CRT
2. receiving all oncology care at Fox Chase Cancer Center (FCCC)
3. able to speak and read in English or with assistance from an interpreter

Exclusion Criteria

1. patients with prior history of HNC for which they underwent CRT
2. 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
3. patients enrolled on other supportive care intervention trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Collaborative palliative and oncology care	Evidenced-based symptom management and coping intervention	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients who comply for acceptability of a collaborative palliative and oncology care intervention for patients with HNC receiving CRT	12 months	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

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with coping strategies longitudinally in relation to symptom burden, QOL, mood, and health care utilization	11 weeks	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)

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States