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Ensuring Communication in Hospice by Oncology Study (ECHO)

Primary Purpose

Ovarian Cancer, Cervical Cancer, Uterine Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
communication with oncology team
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ovarian Cancer focused on measuring Hospice Care, Head and Neck cancer, Gynecological Oncology, Sarcoma, Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult Patient Criteria

    -->18years of age) with a diagnosis of an incurable malignancy of the head and neck, gynecological oncology, sarcoma, or melanoma

    • Receiving oncology care at the MGH Cancer Center
    • Referral to home hospice services in previous five business days.
  • Family Caregiver Eligibility Criteria:

    • Designated adult family/informal caregiver for an eligible patient who will provide the primary home care for the patient receiving hospice services
    • Ability to read and respond to questions in English or with the assistance of a translator
    • Access to telephone and/or computer to communicate with the oncology team and complete questionnaires
    • Willingness to complete weekly questionnaires via telephone or email.

Exclusion Criteria:

  • Patient Exclusion Criteria:

    -- Referral to hospice services away from home (eg in nursing home or in an inpatient or residential setting)

  • Family Caregiver Exclusion Criteria --Person is not the primary caregiver for the patient

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

communication with oncology team

Arm Description

oncology team will be prompted to contact family caregiver and/or patient twice weekly while the patient is receiving hospice care.

Outcomes

Primary Outcome Measures

Evaluate the feasibility of implementing the Ensuring Communication in Hospice by Oncology Study (ECHO) intervention by patients' family caregivers and their oncology providers.
ECHO will be considered feasible if greater than 70% of participants have > 50% of the scheduled phone contact with the oncology team during hospice care, which will be documented in the patient's medical record. Feasibility will also be demonstrated if greater than 70% of the family caregivers completing the questionnaires do so greater than 50% of the time they were scheduled. Finally, feasibility will also be demonstrated if caregivers are able to be contacted and decide upon participation within 5 days of patient hospice enrollment.

Secondary Outcome Measures

Prospectively explore the satisfaction with the overall experience of family caregivers through questionnaires when receiving the ECHO intervention.
Prospectively explore rates of health service utilization in the patients receiving the ECHO intervention in terms of (1) hospice disenrollment; (2) hospitalization; and (3) emergency department visits
Prospectively explore the levels of stress of family caregivers through questionnaires when receiving the ECHO intervention.
Prospectively explore decision making regret of family caregivers through questionnaires when receiving the ECHO intervention.

Full Information

First Posted
February 18, 2014
Last Updated
April 15, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02069769
Brief Title
Ensuring Communication in Hospice by Oncology Study (ECHO)
Official Title
Ensuring Communication in Hospice by Oncology Study (ECHO)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this study is to determine if scheduled communication with the oncology team through phone calls is helpful to caregivers with the transition to hospice care.
Detailed Description
There are four parts of the study. First, the participant will receive phone calls twice a week from the oncology team to check in with how the transition to hospice is going. Second, the participant may choose to have an appointment with the Massachusetts General Hospital oncology team to discuss any questions or concerns regarding cancer care or the transition to hospice. Third, each week of hospice care, the participant will be asked to complete a set of questionnaires at a time that is convenient for them either by phone or by email. These questions will ask the participant about their recent thoughts and feelings about their experience with hospice and as a caregiver. The questions will take less than 15 minutes to answer. Fourth, after hospice care has ended, the participant will be called by the oncology team to again check in and about a month later, the participant will also be contacted by phone to complete a set of questionnaires, again asking about their thoughts and feelings about your experience with hospice and as a caregiver. For all of the questionnaires, the participant may skip any questions that the participant prefers not to answer. The responses will remain confidential and will be available only to study staff members who are trained in confidentiality and research ethics. Additionally, during the research study, the investigators will obtain information from the participant's loved one's Massachusetts General Hospital electronic medical record that is relevant to the participation in the study for up to 6 months. If he/she has visited another hospital during this time, the investigator will also ask the participant for their permission to obtain the medical records from this visit. The participant will not receive any compensation for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Cervical Cancer, Uterine Cancer, Head and Neck Cancer, Sarcoma, Melanoma
Keywords
Hospice Care, Head and Neck cancer, Gynecological Oncology, Sarcoma, Melanoma

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
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
communication with oncology team
Arm Type
Experimental
Arm Description
oncology team will be prompted to contact family caregiver and/or patient twice weekly while the patient is receiving hospice care.
Intervention Type
Behavioral
Intervention Name(s)
communication with oncology team
Intervention Description
Oncology team will contact patients and families via telephone at specific intervals
Primary Outcome Measure Information:
Title
Evaluate the feasibility of implementing the Ensuring Communication in Hospice by Oncology Study (ECHO) intervention by patients' family caregivers and their oncology providers.
Description
ECHO will be considered feasible if greater than 70% of participants have > 50% of the scheduled phone contact with the oncology team during hospice care, which will be documented in the patient's medical record. Feasibility will also be demonstrated if greater than 70% of the family caregivers completing the questionnaires do so greater than 50% of the time they were scheduled. Finally, feasibility will also be demonstrated if caregivers are able to be contacted and decide upon participation within 5 days of patient hospice enrollment.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Prospectively explore the satisfaction with the overall experience of family caregivers through questionnaires when receiving the ECHO intervention.
Time Frame
2 Years
Title
Prospectively explore rates of health service utilization in the patients receiving the ECHO intervention in terms of (1) hospice disenrollment; (2) hospitalization; and (3) emergency department visits
Time Frame
2 Years
Title
Prospectively explore the levels of stress of family caregivers through questionnaires when receiving the ECHO intervention.
Time Frame
2 years
Title
Prospectively explore decision making regret of family caregivers through questionnaires when receiving the ECHO intervention.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult Patient Criteria -->18years of age) with a diagnosis of an incurable malignancy of the head and neck, gynecological oncology, sarcoma, or melanoma Receiving oncology care at the MGH Cancer Center Referral to home hospice services in previous five business days. Family Caregiver Eligibility Criteria: Designated adult family/informal caregiver for an eligible patient who will provide the primary home care for the patient receiving hospice services Ability to read and respond to questions in English or with the assistance of a translator Access to telephone and/or computer to communicate with the oncology team and complete questionnaires Willingness to complete weekly questionnaires via telephone or email. Exclusion Criteria: Patient Exclusion Criteria: -- Referral to hospice services away from home (eg in nursing home or in an inpatient or residential setting) Family Caregiver Exclusion Criteria --Person is not the primary caregiver for the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Temel, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Ensuring Communication in Hospice by Oncology Study (ECHO)

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