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.
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
About this study
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alexi A. Wright, MD, Dana-Farber Cancer Institute
- Investigators
- Alexi A Wright, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
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 35297744Pozzar 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
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.
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.
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.
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
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; AzTrials last refreshed its copy on 8 Nov 2026.