Trial Outcomes & Findings for BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal (NCT NCT03367247)

NCT ID: NCT03367247

Last Updated: 2026-03-10

Results Overview

≥50% consent-to-approach ratio

Recruitment status

COMPLETED

Study phase

Target enrollment

121 participants

Primary outcome timeframe

1 month

Results posted on

2026-03-10

Participant Flow

Participant milestones

Participant milestones
Measure	Phase Ia: 10-week Pre-pilot Patients In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training.	Phase Ia: 10-week Pre-pilot Caregivers In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training.	Phase Ib: 4-week Pre-pilot Patients The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training.	Phase Ib: 4-week Pre-pilot Caregivers The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training.	Phase II (RCT): BOLSTER Arm Patients BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice.	Phase II (RCT): BOLSTER Arm Caregivers BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice.	Phase II (RCT): EDP Arm Patients Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call.	Phase II (RCT): EDP Arm Caregivers Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call.
Overall Study STARTED	6	6	5	4	29	17	32	22
Overall Study COMPLETED	3	3	5	4	21	11	20	15
Overall Study NOT COMPLETED	3	3	0	0	8	6	12	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase Ia: 10-week Pre-pilot Patients n=6 Participants In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training.	Phase Ia: 10-week Pre-pilot Caregivers n=6 Participants In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training.	Phase Ib: 4-week Pre-pilot Patients n=5 Participants The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training.	Phase Ib: 4-week Pre-pilot Caregivers n=4 Participants The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training.	Phase II (RCT): BOLSTER Arm Patients n=29 Participants BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice.	Phase II (RCT): BOLSTER Arm Caregivers n=17 Participants BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice.	Phase II (RCT): EDP Arm Patients n=32 Participants Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call.	Phase II (RCT): EDP Arm Caregivers n=22 Participants Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call.	Total n=121 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 7.31 • n=68 Participants	64 years STANDARD_DEVIATION 6.63 • n=69 Participants	58 years STANDARD_DEVIATION 14.03 • n=137 Participants	62 years STANDARD_DEVIATION 12.48 • n=88 Participants	60 years STANDARD_DEVIATION 10.17 • n=127 Participants	59 years STANDARD_DEVIATION 9.54 • n=605 Participants	62 years STANDARD_DEVIATION 7.51 • n=9 Participants	60 years STANDARD_DEVIATION 10.21 • n=72 Participants	61 years STANDARD_DEVIATION 9.46 • n=6 Participants
Sex: Female, Male Female	6 Participants n=68 Participants	1 Participants n=69 Participants	5 Participants n=137 Participants	1 Participants n=88 Participants	25 Participants n=127 Participants	10 Participants n=605 Participants	31 Participants n=9 Participants	7 Participants n=72 Participants	86 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=68 Participants	5 Participants n=69 Participants	0 Participants n=137 Participants	3 Participants n=88 Participants	4 Participants n=127 Participants	7 Participants n=605 Participants	1 Participants n=9 Participants	15 Participants n=72 Participants	35 Participants n=6 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	0 Participants n=127 Participants	0 Participants n=605 Participants	0 Participants n=9 Participants	0 Participants n=72 Participants	0 Participants n=6 Participants
Race/Ethnicity, Customized Asian	0 Participants n=68 Participants	0 Participants n=69 Participants	1 Participants n=137 Participants	1 Participants n=88 Participants	2 Participants n=127 Participants	1 Participants n=605 Participants	0 Participants n=9 Participants	0 Participants n=72 Participants	5 Participants n=6 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	0 Participants n=127 Participants	0 Participants n=605 Participants	3 Participants n=9 Participants	2 Participants n=72 Participants	5 Participants n=6 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	1 Participants n=605 Participants	0 Participants n=9 Participants	0 Participants n=72 Participants	2 Participants n=6 Participants
Race/Ethnicity, Customized White	6 Participants n=68 Participants	6 Participants n=69 Participants	4 Participants n=137 Participants	3 Participants n=88 Participants	24 Participants n=127 Participants	14 Participants n=605 Participants	26 Participants n=9 Participants	20 Participants n=72 Participants	103 Participants n=6 Participants
Race/Ethnicity, Customized Other	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	0 Participants n=605 Participants	3 Participants n=9 Participants	0 Participants n=72 Participants	4 Participants n=6 Participants
Race/Ethnicity, Customized I don't know/refuse to answer	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	1 Participants n=605 Participants	0 Participants n=9 Participants	0 Participants n=72 Participants	2 Participants n=6 Participants
Ethnicity Hispanic or LatinX	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	0 Participants n=605 Participants	2 Participants n=9 Participants	1 Participants n=72 Participants	4 Participants n=6 Participants
Ethnicity Not Hispanic or LatinX	6 Participants n=68 Participants	6 Participants n=69 Participants	5 Participants n=137 Participants	4 Participants n=88 Participants	27 Participants n=127 Participants	16 Participants n=605 Participants	27 Participants n=9 Participants	21 Participants n=72 Participants	112 Participants n=6 Participants
Ethnicity Missing	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	1 Participants n=605 Participants	3 Participants n=9 Participants	0 Participants n=72 Participants	5 Participants n=6 Participants
Marital Status Married	5 Participants n=68 Participants	6 Participants n=69 Participants	5 Participants n=137 Participants	4 Participants n=88 Participants	22 Participants n=127 Participants	16 Participants n=605 Participants	26 Participants n=9 Participants	20 Participants n=72 Participants	104 Participants n=6 Participants
Marital Status Divorced/Separated	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	2 Participants n=127 Participants	0 Participants n=605 Participants	2 Participants n=9 Participants	2 Participants n=72 Participants	6 Participants n=6 Participants
Marital Status Single, never married	1 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	2 Participants n=127 Participants	0 Participants n=605 Participants	2 Participants n=9 Participants	0 Participants n=72 Participants	5 Participants n=6 Participants
Marital Status Widowed	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	0 Participants n=605 Participants	0 Participants n=9 Participants	0 Participants n=72 Participants	1 Participants n=6 Participants
Marital Status Partnered	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	1 Participants n=605 Participants	1 Participants n=9 Participants	0 Participants n=72 Participants	3 Participants n=6 Participants
Marital Status I don't know/refused	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	0 Participants n=605 Participants	1 Participants n=9 Participants	0 Participants n=72 Participants	2 Participants n=6 Participants
Highest Level of Education 8th grade or less	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	0 Participants n=127 Participants	0 Participants n=605 Participants	0 Participants n=9 Participants	0 Participants n=72 Participants	0 Participants n=6 Participants
Highest Level of Education 9 - 11th grade	0 Participants n=68 Participants	0 Participants n=69 Participants	1 Participants n=137 Participants	0 Participants n=88 Participants	0 Participants n=127 Participants	0 Participants n=605 Participants	1 Participants n=9 Participants	0 Participants n=72 Participants	2 Participants n=6 Participants
Highest Level of Education High school graduate / GED	1 Participants n=68 Participants	2 Participants n=69 Participants	0 Participants n=137 Participants	1 Participants n=88 Participants	1 Participants n=127 Participants	2 Participants n=605 Participants	3 Participants n=9 Participants	1 Participants n=72 Participants	11 Participants n=6 Participants
Highest Level of Education Vocational / Technical training	0 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	0 Participants n=605 Participants	0 Participants n=9 Participants	3 Participants n=72 Participants	4 Participants n=6 Participants
Highest Level of Education Associate degree / some college	0 Participants n=68 Participants	0 Participants n=69 Participants	1 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	1 Participants n=605 Participants	2 Participants n=9 Participants	3 Participants n=72 Participants	8 Participants n=6 Participants
Highest Level of Education Bachelor's degree	2 Participants n=68 Participants	1 Participants n=69 Participants	3 Participants n=137 Participants	2 Participants n=88 Participants	11 Participants n=127 Participants	3 Participants n=605 Participants	11 Participants n=9 Participants	8 Participants n=72 Participants	41 Participants n=6 Participants
Highest Level of Education Advanced degree	2 Participants n=68 Participants	3 Participants n=69 Participants	0 Participants n=137 Participants	1 Participants n=88 Participants	14 Participants n=127 Participants	11 Participants n=605 Participants	14 Participants n=9 Participants	7 Participants n=72 Participants	52 Participants n=6 Participants
Highest Level of Education Refuse to answer	1 Participants n=68 Participants	0 Participants n=69 Participants	0 Participants n=137 Participants	0 Participants n=88 Participants	1 Participants n=127 Participants	0 Participants n=605 Participants	1 Participants n=9 Participants	0 Participants n=72 Participants	3 Participants n=6 Participants

PRIMARY outcome

Timeframe: 1 month

≥50% consent-to-approach ratio

Outcome measures

Outcome measures
Measure	Patients Approached n=95 Participants The number of patients that study staff approached regarding participation in the study	Phase II (RCT): BOLSTER Arm Caregivers BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice.
Feasibility of the BOLSTER Intervention Consented	73 Participants	—
Feasibility of the BOLSTER Intervention Did not consent	22 Participants	—

SECONDARY outcome

Timeframe: 3 months

≥70% participants "agree" or "strongly agree" that they would recommend BOLSTER to other patients; and ≥70% participants "agreed or "strongly agreed" that they were satisfied with the BOLSTER intervention. Note that this measure only includes data from the RCT portion of the study, as the Phases 1a and 1b were designed to refine the intervention.