NCT04049188

Brief Summary

Feasibility study to report on the impact of ACCESS of single-fraction radiation therapy on cancer patients with bone metastases enrolled in hospice care.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

March 5, 2019

Last Update Submit

January 21, 2020

Conditions

Cancer Metastatic

Keywords

Cancer Patients Hospice CarePalliative Radiation Therapy

Outcome Measures

Primary Outcomes (1)

  • Change in Opioid Use for Pain Management

    Opioid Dosage (mg/day)

    Through study completion, an average of 1 year

Secondary Outcomes (2)

  • Improved Quality of Life Measures

    During study completion

  • Improved Activities of Daily Living

    During study completion

Study Arms (1)

Single-Fraction Palliative RT

EXPERIMENTAL

Single-Fraction Palliative Radiation Therapy Adminstration

Radiation: Single-Fraction Palliative Radiation Therapy

Interventions

Single-Fraction Palliative Radiation TherapyRADIATION

All subjects will be undergo single-fraction palliative radiation therapy who have cancer and associated bone metastases and symptomatic bone pain.

Single-Fraction Palliative RT

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Solid Tumor Malignancies and Multiple Myeloma with Bone Metastases and Associated Bone Pain Enrolled in Hospice

You may not qualify if:

  • Decisionally-Impaired Subjects, Pregnant Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CarePartners

Hillsboro, Oregon, 97006, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Andy Kyler, BSN, MBA

CONTACT

5036192621andy.kyler@carepartners.org

Christa Nicholas

CONTACT

5036469565Christa.Nicholas@carepartnersor.org

Study Design

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

Study Record Dates

First Submitted

March 5, 2019

First Posted

August 8, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2021

Study Completion

December 31, 2021

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

US(1)