NCT04053517

Brief Summary

This trial studies the severity of financial distress in advanced cancer patients. The cost of cancer care can often be very expensive. Financial distress from the burdens of high costs and debt may interfere with a patient's physical symptoms and quality of life.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress81%
Jul 2019Dec 2027

Study Start

First participant enrolled

July 2, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

8.5 years

First QC Date

July 15, 2019

Last Update Submit

April 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • InCharge Financial Distress/Financial Well-Being Scale (IFDFW),

    a validated survey designed to measure a person's financial state, consists of eight questions and each of them is rated from 1 (overwhelming stress) to 10 (no stress at all). This should take approximately 5 minutes to complete.

    Day 1

Secondary Outcomes (4)

  • Correlation between high financial distress with clinical characteristics in advance cancer patients

    Day 1

  • Correlation between mean scores of In Charge Financial Distress/ Financial Well-Being Scale (IFDFW) and scores from other financial distress instruments

    Day 1

  • Correlation between high financial distress with patient symptoms in(ESAS) Edmonton Symptom Assessment System

    Day 1

  • Correlation between high financial distress with Quality of life

    Day 1

Study Arms (1)

Observational (questionnaire administration)

Patients complete questionnaires about financial state and quality of life over 15 minutes. Patients' medical chart is also reviewed.

Other: Medical Chart ReviewOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Medical chart is reviewed

Also known as: Chart Review
Observational (questionnaire administration)

Ancillary studies

Also known as: Quality of Life Assessment
Observational (questionnaire administration)

Ancillary studies

Observational (questionnaire administration)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of advanced cancer

You may qualify if:

  • Patient must have a diagnosis of advanced cancer, as defined by recurrent disease, locally advanced disease, metastatic disease, or refractory disease
  • Patients must be able to understand, read, write, and speak English
  • Patients must have no clinical evidence of severe cognitive impairment (Memorial Delirium Assessment Scale score of \>= 13) and should be able to consent and answer the questionnaires
  • Patients must sign an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasm MetastasisRecurrenceNeoplasms

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Jacqueline Tschanz, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

August 12, 2019

Study Start

July 2, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations