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Palliative and Oncology Care Intervention: Symptom COACH

Primary Purpose

Cancer of Head and Neck

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Evidenced-based symptom management and coping intervention

About this trial

This is an interventional supportive care trial for Cancer of Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Collaborative palliative and oncology care

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT03760471

First Posted

November 16, 2018

Last Updated

February 2, 2022

Sponsor

Fox Chase Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03760471

Brief Title

Palliative and Oncology Care Intervention: Symptom COACH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 7, 2018 (Actual)

Primary Completion Date

November 1, 2019 (Actual)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fox Chase Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Head and Neck

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Collaborative palliative and oncology care

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Evidenced-based symptom management and coping intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of patients who comply for acceptability of a collaborative palliative and oncology care intervention for patients with HNC receiving CRT

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Percentage of patients with coping strategies longitudinally in relation to symptom burden, QOL, mood, and health care utilization

Description

Time Frame

11 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111-2497

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Palliative and Oncology Care Intervention: Symptom COACH

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