Trial Outcomes & Findings for Bridge: Proactive Psychiatry Consultation and Case Management for Patients With Cancer (NCT NCT03360695)
NCT ID: NCT03360695
Last Updated: 2024-02-08
Results Overview
The number of patients who experience clinically relevant disruptions in cancer care (e.g. delay to cancer diagnosis or treatment, deviation from stage-appropriate cancer treatment, or interruption in planned treatment).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
185 participants
Primary outcome timeframe
6 months from study enrollment
Results posted on
2024-02-08
Participant Flow
Participant milestones
| Measure |
Enhanced Usual Care (EUC) - Randomized Trial
Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services.
Enhanced Usual Care (EUC): At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services.
|
Proactive Psychiatry Consultation (PPC) - Randomized Trial
Proactive Psychiatry Consultation and Case Management is:
1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity.
2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care.
3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment.
4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.
Proactive Psychiatry Consultation (PPC): Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need.
|
Enhanced Usual Care (EUC) - Randomized Trial: CAREGIVERS
Enrolled caregivers of patients randomized to Enhanced Usual Care (EUC) arm of Randomized Trial.
|
Proactive Psychiatry Consultation (PPC) - Randomized Trial: CAREGIVERS
Enrolled caregivers of patients randomized to Proactive Psychiatry Consultation (PPC) arm of Randomized Trial.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
32
|
33
|
|
Overall Study
COMPLETED
|
57
|
58
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data collected for patients ONLY.
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care (EUC) - Randomized Trial
n=60 Participants
Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services.
Enhanced Usual Care (EUC): At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services.
|
Proactive Psychiatry Consultation (PPC) - Randomized Trial
n=60 Participants
Proactive Psychiatry Consultation and Case Management is:
1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity.
2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care.
3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment.
4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.
Proactive Psychiatry Consultation (PPC): Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need.
|
Enhanced Usual Care (EUC) - Randomized Trial - CAREGIVERS
n=32 Participants
Enrolled caregivers of patients randomized to Enhanced Usual Care (EUC) arm of Randomized Trial.
|
Proactive Psychiatry Consultation (PPC) - Randomized Trial - CAREGIVERS
n=33 Participants
Enrolled caregivers of patients randomized to Proactive Psychiatry Consultation (PPC) arm of Randomized Trial.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 13.2 • n=60 Participants • Age data collected for patients ONLY.
|
60.6 years
STANDARD_DEVIATION 11.8 • n=60 Participants • Age data collected for patients ONLY.
|
—
|
—
|
61.3 years
STANDARD_DEVIATION 12.4 • n=120 Participants • Age data collected for patients ONLY.
|
|
Sex/Gender, Customized
Male
|
25 Participants
n=60 Participants
|
15 Participants
n=60 Participants
|
8 Participants
n=32 Participants
|
12 Participants
n=33 Participants
|
60 Participants
n=185 Participants
|
|
Sex/Gender, Customized
Female
|
33 Participants
n=60 Participants
|
45 Participants
n=60 Participants
|
24 Participants
n=32 Participants
|
21 Participants
n=33 Participants
|
123 Participants
n=185 Participants
|
|
Sex/Gender, Customized
Fluid / Non-Binary
|
1 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=185 Participants
|
|
Sex/Gender, Customized
Missing
|
1 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
3 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=60 Participants
|
56 Participants
n=60 Participants
|
32 Participants
n=32 Participants
|
32 Participants
n=33 Participants
|
176 Participants
n=185 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=33 Participants
|
6 Participants
n=185 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
2 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=60 Participants
|
3 Participants
n=60 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
4 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=32 Participants
|
2 Participants
n=33 Participants
|
6 Participants
n=185 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=60 Participants
|
50 Participants
n=60 Participants
|
28 Participants
n=32 Participants
|
31 Participants
n=33 Participants
|
164 Participants
n=185 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=60 Participants
|
2 Participants
n=60 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
4 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=60 Participants
|
3 Participants
n=60 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=33 Participants
|
5 Participants
n=185 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=60 Participants
|
60 participants
n=60 Participants
|
32 participants
n=32 Participants
|
33 participants
n=33 Participants
|
120 participants
n=185 Participants
|
|
Caregiver Enrolled
No caregiver enrolled
|
28 Participants
n=60 Participants • Data collected for patients ONLY.
|
27 Participants
n=60 Participants • Data collected for patients ONLY.
|
—
|
—
|
55 Participants
n=120 Participants • Data collected for patients ONLY.
|
|
Caregiver Enrolled
Caregiver enrolled
|
32 Participants
n=60 Participants • Data collected for patients ONLY.
|
33 Participants
n=60 Participants • Data collected for patients ONLY.
|
—
|
—
|
65 Participants
n=120 Participants • Data collected for patients ONLY.
|
|
Cancer Diagnosis
Breast
|
14 Participants
n=60 Participants • Cancer diagnosis data collected for patients ONLY.
|
20 Participants
n=60 Participants • Cancer diagnosis data collected for patients ONLY.
|
—
|
—
|
34 Participants
n=120 Participants • Cancer diagnosis data collected for patients ONLY.
|
|
Cancer Diagnosis
Gastrointestinal
|
20 Participants
n=60 Participants • Cancer diagnosis data collected for patients ONLY.
|
10 Participants
n=60 Participants • Cancer diagnosis data collected for patients ONLY.
|
—
|
—
|
30 Participants
n=120 Participants • Cancer diagnosis data collected for patients ONLY.
|
|
Cancer Diagnosis
Head & Neck
|
14 Participants
n=60 Participants • Cancer diagnosis data collected for patients ONLY.
|
14 Participants
n=60 Participants • Cancer diagnosis data collected for patients ONLY.
|
—
|
—
|
28 Participants
n=120 Participants • Cancer diagnosis data collected for patients ONLY.
|
|
Cancer Diagnosis
Lung
|
12 Participants
n=60 Participants • Cancer diagnosis data collected for patients ONLY.
|
16 Participants
n=60 Participants • Cancer diagnosis data collected for patients ONLY.
|
—
|
—
|
28 Participants
n=120 Participants • Cancer diagnosis data collected for patients ONLY.
|
|
Severe Mental Illness Diagnosis
Bipolar Depression
|
25 Participants
n=60 Participants • SMI data collected for patients ONLY.
|
22 Participants
n=60 Participants • SMI data collected for patients ONLY.
|
—
|
—
|
47 Participants
n=120 Participants • SMI data collected for patients ONLY.
|
|
Severe Mental Illness Diagnosis
Depression
|
24 Participants
n=60 Participants • SMI data collected for patients ONLY.
|
26 Participants
n=60 Participants • SMI data collected for patients ONLY.
|
—
|
—
|
50 Participants
n=120 Participants • SMI data collected for patients ONLY.
|
|
Severe Mental Illness Diagnosis
Schiz Spectrum Disorder
|
11 Participants
n=60 Participants • SMI data collected for patients ONLY.
|
12 Participants
n=60 Participants • SMI data collected for patients ONLY.
|
—
|
—
|
23 Participants
n=120 Participants • SMI data collected for patients ONLY.
|
|
Psychiatrist
No psychiatrist
|
26 Participants
n=60 Participants • Data point collected for patients ONLY.
|
35 Participants
n=60 Participants • Data point collected for patients ONLY.
|
—
|
—
|
61 Participants
n=120 Participants • Data point collected for patients ONLY.
|
|
Psychiatrist
Has psychiatrist
|
34 Participants
n=60 Participants • Data point collected for patients ONLY.
|
25 Participants
n=60 Participants • Data point collected for patients ONLY.
|
—
|
—
|
59 Participants
n=120 Participants • Data point collected for patients ONLY.
|
|
Relationship to Patient
Married / Living as if married
|
—
|
—
|
14 Participants
n=32 Participants • Data point collected for caregivers ONLY.
|
14 Participants
n=33 Participants • Data point collected for caregivers ONLY.
|
28 Participants
n=65 Participants • Data point collected for caregivers ONLY.
|
|
Relationship to Patient
Non-cohabitating relationship
|
—
|
—
|
3 Participants
n=32 Participants • Data point collected for caregivers ONLY.
|
1 Participants
n=33 Participants • Data point collected for caregivers ONLY.
|
4 Participants
n=65 Participants • Data point collected for caregivers ONLY.
|
|
Relationship to Patient
Divorced / separated
|
—
|
—
|
1 Participants
n=32 Participants • Data point collected for caregivers ONLY.
|
0 Participants
n=33 Participants • Data point collected for caregivers ONLY.
|
1 Participants
n=65 Participants • Data point collected for caregivers ONLY.
|
|
Relationship to Patient
Friend
|
—
|
—
|
1 Participants
n=32 Participants • Data point collected for caregivers ONLY.
|
1 Participants
n=33 Participants • Data point collected for caregivers ONLY.
|
2 Participants
n=65 Participants • Data point collected for caregivers ONLY.
|
|
Relationship to Patient
Family member
|
—
|
—
|
9 Participants
n=32 Participants • Data point collected for caregivers ONLY.
|
14 Participants
n=33 Participants • Data point collected for caregivers ONLY.
|
23 Participants
n=65 Participants • Data point collected for caregivers ONLY.
|
|
Relationship to Patient
Work with through community mental health
|
—
|
—
|
4 Participants
n=32 Participants • Data point collected for caregivers ONLY.
|
2 Participants
n=33 Participants • Data point collected for caregivers ONLY.
|
6 Participants
n=65 Participants • Data point collected for caregivers ONLY.
|
|
Relationship to Patient
Other
|
—
|
—
|
0 Participants
n=32 Participants • Data point collected for caregivers ONLY.
|
1 Participants
n=33 Participants • Data point collected for caregivers ONLY.
|
1 Participants
n=65 Participants • Data point collected for caregivers ONLY.
|
PRIMARY outcome
Timeframe: 6 months from study enrollmentThe number of patients who experience clinically relevant disruptions in cancer care (e.g. delay to cancer diagnosis or treatment, deviation from stage-appropriate cancer treatment, or interruption in planned treatment).
Outcome measures
| Measure |
Enhanced Usual Care (EUC) - Randomized Trial
n=57 Participants
Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services.
Enhanced Usual Care (EUC): At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services.
|
Proactive Psychiatry Consultation (PPC) - Randomized Trial
n=58 Participants
Proactive Psychiatry Consultation and Case Management is:
1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity.
2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care.
3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment.
4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.
Proactive Psychiatry Consultation (PPC): Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need.
|
|---|---|---|
|
Disruptions in Cancer Care
Any Disruption
|
37 Participants
|
48 Participants
|
|
Disruptions in Cancer Care
No Disruption
|
20 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Week 0, Week 12, Week 24Brief Psychiatric Rating Scale (BPRS) 24 24-item instrument where the rater enters a number for each symptom. Each symptom construct is rated on a Likert scale from 1 (NOT PRESENT) - 7 (EXTREMELY SEVERE). The sum of all 24 items is then calculated to a maximum score of 168 (24X7=168). The minimum score is 24 and the maximum score is 168. The higher the score, the more psychiatrically impaired the patient is. Higher scores mean worse psychiatric symptoms.
Outcome measures
| Measure |
Enhanced Usual Care (EUC) - Randomized Trial
n=57 Participants
Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services.
Enhanced Usual Care (EUC): At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services.
|
Proactive Psychiatry Consultation (PPC) - Randomized Trial
n=58 Participants
Proactive Psychiatry Consultation and Case Management is:
1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity.
2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care.
3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment.
4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.
Proactive Psychiatry Consultation (PPC): Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need.
|
|---|---|---|
|
BPRS (24)
Week 12
|
43.06 score on a scale
Standard Deviation 12.71
|
44.96 score on a scale
Standard Deviation 12.26
|
|
BPRS (24)
Week 24
|
46.1 score on a scale
Standard Deviation 14.03
|
41.22 score on a scale
Standard Deviation 10.31
|
|
BPRS (24)
Week 0
|
46.51 score on a scale
Standard Deviation 11.25
|
47.44 score on a scale
Standard Deviation 13.76
|
SECONDARY outcome
Timeframe: Week 0, Week 6, Week 12, Week 24Patient Health Questionnaire-9 is a 9-item instrument that measures patient depression where a score of 1-4 indicates minimal depression, 5-9 Mild depression, 10-14 Moderate depression, 15-19 Moderately severe depression, 20-27 Severe depression. The minimum score is 1 and the maximum score is 27.
Outcome measures
| Measure |
Enhanced Usual Care (EUC) - Randomized Trial
n=57 Participants
Study staff will send a templated email to the treating oncologist at enrollment informing the oncologists of the psychiatric diagnosis and available psychosocial services. Study staff will also inform the patient and caregiver of available psychosocial services.
Enhanced Usual Care (EUC): At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services.
|
Proactive Psychiatry Consultation (PPC) - Randomized Trial
n=58 Participants
Proactive Psychiatry Consultation and Case Management is:
1. Patient-centered: Based on the patient's needs, the team aims to build a relationship, increase engagement, and promote continuity.
2. Team-based: A psychiatrist and case manager identify goals for cancer treatment, assess psychiatric history and symptoms with a focus on impact on cancer care, collaborate with community-based clinicians and caregivers, and address barriers to care.
3. Integrated into cancer care delivery: The psychiatry and oncology teams collaborate starting at cancer diagnosis to support patient through cancer treatment.
4. Systematic: The team monitors psychiatric and cancer-related symptoms and cancer care delivery to measure progress toward goals and rapidly adjust treatment as needed.
Proactive Psychiatry Consultation (PPC): Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need.
|
|---|---|---|
|
PHQ-9
Week 0
|
9.67 score on a scale
Standard Deviation 6.02
|
9.09 score on a scale
Standard Deviation 6.72
|
|
PHQ-9
Week 6
|
9.60 score on a scale
Standard Deviation 5.98
|
7.89 score on a scale
Standard Deviation 5.43
|
|
PHQ-9
Week 12
|
9.78 score on a scale
Standard Deviation 6.25
|
7.72 score on a scale
Standard Deviation 5.77
|
|
PHQ-9
Week 24
|
8.05 score on a scale
Standard Deviation 6.34
|
6.93 score on a scale
Standard Deviation 5.50
|
Adverse Events
Enhanced Usual Care (EUC) - Randomized Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Proactive Psychiatry Consultation (PPC) - Randomized Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place