Palliative and Oncology Care Intervention: Symptom COACH

NCT03760471 | Unknown

• 1 other identifier: 18-1054
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Head and Neck

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  11 weeks

Study Arms (1)

Collaborative palliative and oncology care

EXPERIMENTAL

Other: Evidenced-based symptom management and coping intervention

Interventions

Evidenced-based symptom management and coping intervention 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

Collaborative palliative and oncology care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 30, 2018
• Study Start: November 7, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2022
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)