Gynecologic CancerNCT03367247

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

A study testing BOLSTER and Enhanced Discharge Planning (EDP) in people with Gynecologic Cancer and Gastrointestinal Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This research study is evaluating a new intervention, BOLSTER, which was designed to provide more support for patients with gynecologic and gastrointestinal cancers and their caregivers after a hospitalization. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gynecologic Cancer, Gastrointestinal Cancer
What is being tested?: BOLSTER and Enhanced Discharge Planning (EDP)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2018to 27 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Patient inclusion criteria

Adults (≥18 years old);
GYN or GI cancers receiving anti-neoplastic therapy;
Hospitalized, recently hospitalized (i.e. within the first 2 visits after a hospitalization), or recent outpatient placement of tube, line, or drain (e.g. PleurX catheter);
Plan to receive ongoing care at DFCI;
Willingness to be audio taped for the study (for monitoring of study fidelity).
Have complex care needs (e.g. an ostomy, ileostomy, a gastric tube, percutaneous nephrostomy tubes, a PleurX catheter, or need for total parenteral nutrition)

Patient exclusion criteria

Unable to read and respond to questions in English;
Cognitive impairment;
Unable to complete the baseline interview;
Plan for immediate hospice referral

Caregiver inclusion criteria

Adults (≥18 years old);
Family member or friend of an eligible patient;
Willingness to be audio taped for the study (for monitoring of study fidelity);
Willingness to participate in study visits

Caregiver exclusion criteria:

Unable to read and respond to questions in English,
Cognitive impairment
Unable to complete the baseline interview

Trial locations and contacts

1 site in 1 country.

United States1 site

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215

Other trials in United States

About this study

Read the detailed description

Hospitalizations can be difficult for patients with cancer, especially when they are transitioning home. Patients and caregivers are often expected to perform complex medical and nursing tasks with little or no preparation. Patients and caregivers report high levels of unmet needs for information about how best to manage symptoms and new medical procedures (such as managing new tubes, lines or drains).

The study team has developed a research project which aims to address these needs. If a patient agrees to participate in the study, she will take part in a program called BOLSTER (Building Out Lifelines for Safety, Trust, Empowerment and Renewal). BOLSTER will provide patients and caregivers with education and skills training, symptom management, and support across care settings.

Conditions: Gynecologic Cancer, Gastrointestinal Cancer
Being tested: BOLSTER, Enhanced Discharge Planning (EDP)
Keywords: Ovarian Cancer, Bowel blockage, Ascites, Supportive care, Nursing, Mobile health, m-Health, Tele-health, Palliative Care, Symptom management, Gastrointestinal Cancer, Gynecologic Cancer, Complex Care Needs
Medical subject headings: Gastrointestinal Neoplasms, Ovarian Neoplasms, Ascites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BOLSTERBehavioural
BOLSTER provides patients and caregivers with education and skills training, symptom management, and support across care settings over a four-week period.
Enhanced Discharge Planning (EDP)Other
EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.

Study groups in NCT03367247
Study group	Role	What they receive
Bolster	Experimental	* Bolster provides participants with longitudinal nursing support across care settings, * A smartphone-based symptom management app, * A print and web-based symptom management toolkit, * 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 Receives: Behavioral: BOLSTER
Enhanced Discharge Planning (EDP)	Other	* Medication education, * Self-management strategies for symptoms, * Skills training, * A list of red flag symptoms and numbers for who to call Receives: Other: Enhanced Discharge Planning (EDP)

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of the BOLSTER Intervention
≥50% consent-to-approach ratio
Measured: 1 month

Secondary outcomes (1)

Acceptability of the BOLSTER Intervention
≥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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 201827 Jul 2023

First posted8 Dec 2017
Study start24 Apr 2018
Primary completion30 Jun 2022
Study completion27 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gynecologic CancerStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Model description: Phase I: Single-arm study with up to 20 ovarian cancer patients and their informal caregivers run-in. Phase II: Two-arm pilot RCT with 60 gynecologic or gastrointestinal cancer patients and their informal caregivers (30 dyads in each arm).
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03367247
Sponsor's protocol ID: 17-475
Other IDs: CA166210, R21CA223684
Status last verified: Feb 2026
First submitted: 28 Nov 2017
Last updated: 10 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pozzar RA, Enzinger AC, Poort H, Furey A, Donovan H, Orechia M, Thompson E, Tavormina A, Fenton ATHR, Jaung T, Braun IM, DeMarsh A, Cooley ME, Wright AA. Developing and Field Testing BOLSTER: A Nurse-Led Care Management Intervention to Support Patients and Caregivers following Hospitalization for Gynecologic Cancer-Associated Peritoneal Carcinomatosis. J Palliat Med. 2022 Sep;25(9):1367-1375. doi: 10.1089/jpm.2021.0618. Epub 2022 Mar 17.
PubMed 35297744
Pozzar RA, Enzinger AC, Howard C, Tavormina A, Matulonis UA, Campos S, Liu JF, Horowitz N, Konstantinopoulos PA, Krasner C, Wall JA, Sciacca K, Meyer LA, Lindvall C, Wright AA. Feasibility and acceptability of a nurse-led telehealth intervention (BOLSTER) to support patients with peritoneal carcinomatosis and their caregivers: A pilot randomized clinical trial. Gynecol Oncol. 2024 Sep;188:1-7. doi: 10.1016/j.ygyno.2024.06.001. Epub 2024 Jun 7.
PubMed 38851039

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal
ClinicalTrials.gov ID: NCT03367247
Acronym / sponsor ID: 17-475
Conditions: Gynecologic Cancer, Gastrointestinal Cancer
Keywords: Ovarian Cancer, Bowel blockage, Ascites, Supportive care, Nursing, Mobile health, m-Health, Tele-health
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 24 Apr 2018 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 27 Jul 2023 (actual)
First posted: 8 Dec 2017 (actual)
Results: Posted 15 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Phase I: Single-arm study with up to 20 ovarian cancer patients and their informal caregivers run-in. Phase II: Two-arm pilot RCT with 60 gynecologic or gastrointestinal cancer patients and their informal caregivers (30 dyads in each arm).

Arm	Type	Receives
Bolster	Experimental	Behavioral: BOLSTER* Bolster provides participants with longitudinal nursing support across care settings, * A smartphone-based symptom management app, * A print and web-based symptom management toolkit, * 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
Enhanced Discharge Planning (EDP)	Other	Other: Enhanced Discharge Planning (EDP)* Medication education, * Self-management strategies for symptoms, * Skills training, * A list of red flag symptoms and numbers for who to call

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BOLSTERBOLSTER provides patients and caregivers with education and skills training, symptom management, and support across care settings over a four-week period.	Behavioural	Bolster
Enhanced Discharge Planning (EDP)EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.	Other	Enhanced Discharge Planning (EDP)

Primary outcome

Feasibility of the BOLSTER Intervention
Time frame: 1 month
≥50% consent-to-approach ratio

1 secondary outcome

Acceptability of the BOLSTER Intervention
Time frame: 3 months

Results and safety

Results posted to the registry on 15 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase Ia: 10-week Pre-pilot Patients	6	3
Phase Ia: 10-week Pre-pilot Caregivers	6	3
Phase Ib: 4-week Pre-pilot Patients	5	5
Phase Ib: 4-week Pre-pilot Caregivers	4	4
Phase II (RCT): BOLSTER Arm Patients	29	21
Phase II (RCT): BOLSTER Arm Caregivers	17	11
Phase II (RCT): EDP Arm Patients	32	20
Phase II (RCT): EDP Arm Caregivers	22	15

Primary outcome: Feasibility of the BOLSTER Intervention

Time frame: 1 month. Count of participants. Unit: Participants

Measure	Patients Approached n = 95
Consented	73
Did not consent	22

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected for 2 months while patients were on study, since this is a minimal risk study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase Ia: 10-week Pre-pilot Patients	0 of 6 (0%)	0 of 6 (0%)	3 of 6
Phase Ia: 10-week Pre-pilot Caregivers	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Phase Ib: 4-week Pre-pilot Patients	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Phase Ib: 4-week Pre-pilot Caregivers	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Phase II (RCT): BOLSTER Arm Patients	0 of 29 (0%)	0 of 29 (0%)	5 of 29
Phase II (RCT): BOLSTER Arm Caregivers	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Phase II (RCT): EDP Arm Patients	0 of 32 (0%)	0 of 32 (0%)	3 of 32
Phase II (RCT): EDP Arm Caregivers	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 35297744Pozzar RA, Enzinger AC, Poort H, Furey A, Donovan H, Orechia M, Thompson E, Tavormina A, Fenton ATHR, Jaung T, Braun IM, DeMarsh A, Cooley ME, Wright AA. Developing and Field Testing BOLSTER: A Nurse-Led Care Management Intervention to Support Patients and Caregivers following Hospitalization for Gynecologic Cancer-Associated Peritoneal Carcinomatosis. J Palliat Med. 2022 Sep;25(9):1367-1375. doi: 10.1089/jpm.2021.0618. Epub 2022 Mar 17.
Derived from this study: PubMed 38851039Pozzar RA, Enzinger AC, Howard C, Tavormina A, Matulonis UA, Campos S, Liu JF, Horowitz N, Konstantinopoulos PA, Krasner C, Wall JA, Sciacca K, Meyer LA, Lindvall C, Wright AA. Feasibility and acceptability of a nurse-led telehealth intervention (BOLSTER) to support patients with peritoneal carcinomatosis and their caregivers: A pilot randomized clinical trial. Gynecol Oncol. 2024 Sep;188:1-7. doi: 10.1016/j.ygyno.2024.06.001. Epub 2024 Jun 7.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexi A Wright, MD, MPH principal investigator

Dana-Farber Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BOLSTER and Enhanced Discharge Planning (EDP) in people with Gynecologic Cancer and Gastrointestinal Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the BOLSTER Intervention (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03367247, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.