N/A Completed N=306 Randomized Double-blind Health Services Research

Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment

Cancer

Source: ClinicalTrials.gov NCT02232074 ↗

Enrolled (actual)

306

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcomePrimary: Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants — 94; 92 Participants — p=0.77

Summary

The investigators plan to compare standard patient navigation with an enhanced navigation partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal needs of newly diagnosed cancer patients in addition to other barriers to care leads to better clinical outcomes.

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants	94; 92	0.77
PRIMARY Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants	7; 7	0.26
SECONDARY Distress Thermometer at 3 Months for BREAST Cancer Patients	5.60; 5.90	0.53
SECONDARY Distress Thermometer at 3 Months for LUNG Cancer Patients	4.50; 6.10	0.43
SECONDARY Distress Thermometer at 6 Months for BREAST Cancer Patients	4.50; 5.20	0.18
SECONDARY Distress Thermometer at 6 Months for LUNG Cancer Patients	1.50; 4.00	0.33
SECONDARY Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients	1.70; 1.70	0.68
SECONDARY Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients	1.40; 1.50	0.26
SECONDARY Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients	40.4; 39.7	0.62
SECONDARY Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients	40.3; 39.0	0.69
SECONDARY Self-efficacy for BREAST Cancer Patients at 6 Months	44.0; 43.3	0.58
SECONDARY Self-efficacy for LUNG Cancer Patients at 6 Months	47.0; 43.0	0.09
SECONDARY Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis	6; 6	0.79
SECONDARY Distress Thermometer at 12 Months for BREAST Cancer Patients	5.3; 5.3	0.71
SECONDARY Distress Thermometer at 12 Months for LUNG Cancer Patients	3.6; 6.0	0.61
SECONDARY Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients	1.70; 1.70	0.46
SECONDARY Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients	1.50; 1.50	0.89
SECONDARY Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients	40.8; 38.4	0.16
SECONDARY Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients	37.7; 42.5	0.16
SECONDARY Self-efficacy for BREAST Cancer Patients at 12 Months	44.2; 43.0	0.13
SECONDARY Self-efficacy for LUNG Cancer Patients at 12 Months	44.2; 43.6	0.80

Eligibility Criteria

Inclusion Criteria

Newly diagnosed breast and lung cancer patients
Within 30 days of patient being informed of diagnosis
Receiving cancer care at Boston Medical Center
No history of cancer treatment in past 5 years
No cognitive impairments
Over 18 years of age
Speak English, Spanish or Haitian Creole

Exclusion Criteria

Patient informed of cancer diagnosis >30 days
Patient under 18 yrs. of age
Primary language something other than English, Spanish or Haitian Creole
Undergoing treatment for concurrent cancer
Patient has history of cancer or has received cancer treatment within the last 5 years
Institutionalized/cognitive impairment (such as: dementia or metabolic, medication or drug induced), given the unique challenges to their treatment decision making/adherence and the fact that the intervention would not include the patient directly, but rather the family.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02232074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.