Randomized Study of a Hospice Video Educational Tool for Patients With Advanced Cancer and Their Caregivers

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03040102
Collaborator
Gordon and Betty Moore Foundation (Other)
194
1
2
22.8
8.5

Study Details

Study Description

Brief Summary

The purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services

Condition or Disease Intervention/Treatment Phase
  • Other: Hospice Video Educational Tool
  • Other: Standard of Care
N/A

Detailed Description

The purpose of this research study is to compare two ways to educate patients with cancer and their caregivers about hospice care services - a video educational tool or a verbal narrative. The study will assess the effect of these methods on patients' and caregivers' knowledge about hospice care, as well as their perceptions and preferences for this service.

Using this research, the investigators hope to find out the best way to help patients and their loved ones better understand hospice care. The educational methods used in this study (the video educational tool or verbal narrative) are meant to serve as an introduction to hospice care. Further details about hospice should be discussed directly with your care team.

This study will enroll 150 patients with advanced cancer and up to 150 of their caregivers in this randomized clinical trial. The study will use questionnaires to measure the participant and the caregivers' knowledge of hospice care, as well as your perceptions and preferences for these services. Study assessments will be completed before and after watching the video or hearing the verbal narrative in the hospital.

Study Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Randomized Study of a Hospice Video Educational Tool for Patients With Advanced Cancer and Their Caregivers
Actual Study Start Date :
Mar 9, 2017
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hospice Video Educational Tool

The hospice video educational tool is a 6 minute video Participants will watch an approximately 6-minute digital video regarding hospice on an iPad

Other: Hospice Video Educational Tool
it's a 6 minute video regarding hospice care

Active Comparator: Hospice Verbal Narrative

The RA will read a verbal narrative that is identical to the narrative of the video to participants Standard of Care practice is used

Other: Standard of Care
Standard of Care practice is used

Outcome Measures

Primary Outcome Measures

  1. Patient Preference for Hospice Question [immediately after the video intervention or verbal narrative]

    We will ask patients whether they would prefer to receive hospice care at the end of life (yes vs. no)

Secondary Outcome Measures

  1. Patient knowledge about hospice Questionnaire [immediately after the video intervention or verbal narrative]

    we will assess knowledge about hospice using 10 knowledge questions

Other Outcome Measures

  1. Patient Perception of Hospice Care Questionnaire [immediately after the video intervention or verbal narrative]

    we will assess perception of hospice using the Hospice Perception Questionnaire

  2. Patient Hospice Utilization [1 year after study completion]

    We will assess patient hospice utilization and length of stay in hospice

  3. Caregiver Preference for Hospice Question [immediately after the video intervention or verbal narrative]

    we will assess caregiver's preference for their loved one using hospice (yes vs. no)

  4. Caregiver Knowledge about Hospice Questionnaire [immediately after the video intervention or verbal narrative]

    we will assess knowledge about hospice using 10 knowledge questions

  5. Caregiver Perception of Hospice Care Questionnaire [immediately after the video intervention or verbal narrative]

    we will assess perception of hospice using the Hospice Perception Questionnaire

  6. Caregiver satisfaction with end-of-life care (FAMCARE) [1 year after study completion]

    We will use 9 items from the FAMCARE to assess caregivers' satisfaction with patient's end of life care

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
Patients Eligibility Criteria:
  • Adult patients (≥18 years) with a diagnosis of metastatic solid cancer.

  • A prognosis of 12 months or less based on the treating oncologist's assessment.

  • The ability to provide informed consent.

  • Ability to comprehend and speak English.

Caregivers Eligibility Criteria:
  • Adult caregivers (>18 years) of patients who have agreed to participate in study.

  • A relative or a friend upon whom the patient relies for help and who will be likely to be present during hospitalization, or willing to participate by phone.

  • Ability to comprehend and speak English.

Exclusion Criteria:
Patients Exclusion Criteria:

-Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts general Hospital Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Gordon and Betty Moore Foundation

Investigators

  • Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
El-Jawahri, Areej,M.D., Areej El-Jawahri, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT03040102
Other Study ID Numbers:
  • 17-026
First Posted:
Feb 2, 2017
Last Update Posted:
Oct 1, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by El-Jawahri, Areej,M.D., Areej El-Jawahri, MD, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 1, 2019