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Palliative and Oncology Care Intervention: Symptom COACH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03760471
Recruitment Status : Active, not recruiting
First Posted : November 30, 2018
Last Update Posted : February 3, 2022
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Other: Evidenced-based symptom management and coping intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Collaborative Palliative and Oncology Care Intervention to Improve Symptoms and Coping During Treatment for Head and Neck Cancer
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Collaborative palliative and oncology care Other: Evidenced-based symptom management and coping intervention
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients who comply for acceptability of a collaborative palliative and oncology care intervention for patients with HNC receiving CRT [ Time Frame: 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 :
  1. Percentage of patients with coping strategies longitudinally in relation to symptom burden, QOL, mood, and health care utilization [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760471


Locations
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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
More Information
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Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT03760471    
Other Study ID Numbers: 18-1054
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: February 3, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms