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

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

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Other: Hospice Video Educational Tool; Other: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Preference for Hospice Question	We will ask patients whether they would prefer to receive hospice care at the end of life (yes vs. no)	immediately after the video intervention or verbal narrative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient knowledge about hospice Questionnaire	we will assess knowledge about hospice using 10 knowledge questions	immediately after the video intervention or verbal narrative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Perception of Hospice Care Questionnaire	we will assess perception of hospice using the Hospice Perception Questionnaire	immediately after the video intervention or verbal narrative
Patient Hospice Utilization	We will assess patient hospice utilization and length of stay in hospice	1 year after study completion
Caregiver Preference for Hospice Question	we will assess caregiver's preference for their loved one using hospice (yes vs. no)	immediately after the video intervention or verbal narrative
Caregiver Knowledge about Hospice Questionnaire	we will assess knowledge about hospice using 10 knowledge questions	immediately after the video intervention or verbal narrative
Caregiver Perception of Hospice Care Questionnaire	we will assess perception of hospice using the Hospice Perception Questionnaire	immediately after the video intervention or verbal narrative
Caregiver satisfaction with end-of-life care (FAMCARE)	We will use 9 items from the FAMCARE to assess caregivers' satisfaction with patient's end of life care	1 year after study completion

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Gordon and Betty Moore Foundation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2017
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: January 28, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (ESTIMATE): February 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 28, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Advanced Cancer
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 17-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No