Palliative and Oncology Care Intervention: Symptom COACH

NCT ID: NCT03760471

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2022-11-30

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.

Detailed Description

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Conditions

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Cancer of Head and Neck

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Collaborative palliative and oncology care

Group Type EXPERIMENTAL

Evidenced-based symptom management and coping intervention

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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18-1054

Identifier Type: -

Identifier Source: org_study_id

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