Gastrointestinal CancerBOLSTERNCT06936878
BOLSTER: Learning New Skills to Thrive
A study testing BOLSTER Program in people with Gastrointestinal Cancer and Gynecologic Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research study is evaluating a new program called Building Out Lifelines for Safety, Trust, Empowerment, and Renewal or (BOLSTER), which was designed to support participants with a gynecological or gastrointestinal cancer and new and complex care needs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Gynecologic Cancer, Advanced Cancer
- What is being tested?
- BOLSTER Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 May 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Participant Inclusion Criteria:
- Age ≥18 years
- Currently hospitalized with skilled care need or have acquired a new skilled care need as an outpatient
- Diagnosed with advanced gastrointestinal cancer (esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or advanced gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar)
- Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound VAC)
- Plans to receive ongoing cancer treatment
- Has a family caregiver or friend (hereafter designated family caregiver) willing to participate
- Able to speak and read English or Spanish (self-report)
- Are willing to be audio-recorded
- Have the cognitive/physical ability to participate in a 60-minute interview
Family or Caregiver Inclusion Criteria:
- Age ≥ 18 years
- Identified by a patient (as defined above) as a family or friend who is involved in their care.
- Willing to participate in study visits
- Willing to be audio recorded
Participant Exclusion Criteria:
- Has cognitive impairments (as determined by the patient's oncologist)
- Planning to enroll in hospice
- Unable to complete baseline survey
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Family or Caregiver Exclusion Criteria:
- Unable to complete baseline survey
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Alexi Wright, MD, MPH, 617-632-2334, Alexi_Wright@dfci.harvard.edu
Alexi Wright, MD, MPH
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Larissa Meyer, MD, 713-745-0973, lmeyer@mdanderson.org
Maria Iniesta-Donate, MD, PhD, 281-928-9892, miniesta@mdanderson.org
About this study
Official title: BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers
This research study is evaluating a new program called Building Out Lifelines for Safety, Trust, Empowerment, and Renewal or (BOLSTER), which was designed to support participants with a gynecological or gastrointestinal cancer and new and complex care needs.
Read the detailed description
This multi-center, randomized trial is to test the efficacy of the BOLSTER Program and to improve participant quality of life (QOL), alleviate symptoms, reduce burden, and decrease the need for hospital care in participants with complex care needs from advanced gastrointestinal and gynecologic (GI/GYN) cancers.
The research study procedures include screening for eligibility, questionnaires, and telehealth visits.
Participation in this research study is expected to last about 12 weeks.
About 300 dyads (patients with family caregivers) are expected to participate in this research study.
The National Cancer Institute is funding this research study by providing funding.
- Conditions
- Gastrointestinal Cancer, Gynecologic Cancer, Advanced Cancer
- Being tested
- BOLSTER Program
- Keywords
- Gastrointestinal Cancer, Gynecologic Cancer, Advanced Cancer, Advanced Gastrointestinal Cancer, Advanced Gynecologic Cancer
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOLSTER ProgramBehavioural
Also called BOLSTER
This supportive care program includes six telehealth sessions led by a trained nurse to help patients with advanced gynecological or gastrointestinal cancers and their care partners build skills, manage symptoms, and cope with challenges. Two additional sessions will be help support care partners. Participants will also get access to the BOLSTER website, which offers personalized educational materials to support their well-being
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Usual Care | No intervention | Participants and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete: * Baseline visit * Standard-of-care oncology appointments * Access to nurse and specialist appointments * 6 week survey * 12 week survey |
| Arm 2: Bolster Program | Experimental | Patients and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete:
* Baseline visit
* 6 telehealth sessions with a nurse for patients and their care partners
* 2 brief telehealth sessions for care partners.
* Access to the Bolster Program website with tailored educational materials
* 6 week survey
* 12 week survey Receives: Behavioral: BOLSTER Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Measured: Baseline to 6 weeks post-discharge
Change in FACT-G Score From Baseline to Week 6 (Arm 2)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Measured: Baseline to 6 weeks post-discharge
Secondary outcomes (39)
Change in FACT-G Score From Baseline to Week 12 (Arm 1)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Measured: Baseline to 12 weeks post-discharge
Change in FACT-G Score From Baseline to Week 12 (Arm 2)
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Measured: Baseline to 12 weeks post-discharge
Change in Functional Assessment of Cancer Therapy-General 7 item Version (FACT-G7) Score from Baseline to Week 6 (Arm 1)
Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 28. A higher score indicates better quality of life.
Measured: Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)
Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 28. A higher score indicates better quality of life.
Measured: Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 12 (Arm 1)
Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 28. A higher score indicates better quality of life.
Measured: Baseline to 12 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 12 (Arm 2)
Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 28. A higher score indicates better quality of life.
Measured: Baseline to 12 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 1)
Assessed by the Self-Efficacy for Managing Chronic Conditions - Short Form 4a, an 8-item measure for determining managements of symptoms and medications. Answers are rated on a 5-point Likert scale from 1 "I am not at all confident" to 5 "I am very confident" with a total scores range of 0 to 40. A higher score indicates greater self-efficacy.
Measured: Baseline to 6 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 2)
Assessed by the Self-Efficacy for Managing Chronic Conditions - Short Form 4a, an 8-item measure for determining managements of symptoms and medications. Answers are rated on a 5-point Likert scale from 1 "I am not at all confident" to 5 "I am very confident" with a total scores range of 0 to 40. A higher score indicates greater self-efficacy.
Measured: Baseline to 6 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 1)
Assessed by the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Care Needs and Managing Medications and Treatment. The Managing Care Needs (7 items) and Managing Medications and Treatment - Short Form 4a (6 items) evaluate confidence in handling medical care, including managing devices, medications, and symptoms. Responses are rated on a 5-point Likert scale from 1 ("Not at all confident") to 5 ("Very confident"), with higher scores indicating greater self-efficacy.
Measured: Baseline to 12 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 2)
Assessed by the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Care Needs and Managing Medications and Treatment. The Managing Care Needs (7 items) and Managing Medications and Treatment - Short Form 4a (6 items) evaluate confidence in handling medical care, including managing devices, medications, and symptoms. Responses are rated on a 5-point Likert scale from 1 ("Not at all confident") to 5 ("Very confident"), with higher scores indicating greater self-efficacy.
Measured: Baseline to 12 weeks post-discharge
Change in Health Care Utilization from Baseline to Week 12 (Arm 1)
Defined as the numeric value of the frequency of health care utilization by participant and collected by the Health Care Utilization Report, which is a log that covers the previous 12 weeks and collects emergency room visits, hospitalizations, and rehabilitation admissions.
Measured: Baseline to 12 weeks post-discharge
Change in Health Care Utilization from Baseline to Week 12 (Arm 2)
Defined as the numeric value of the frequency of health care utilization by participant and collected by the Health Care Utilization Report, which is a log that covers the previous 12 weeks and collects emergency room visits, hospitalizations, and rehabilitation admissions.
Measured: Baseline to 12 weeks post-discharge
Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 1)
ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.
Measured: Baseline to 12 weeks post-discharge
Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 2)
ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.
Measured: Baseline to 12 weeks post-discharge
Change in Participant Hospital Anxiety and Depression (HADS) Anxiety Subscale Score from Baseline to Week 6 (Arm 1)
Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Measured: Baseline to 6 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)
Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Measured: Baseline to 6 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)
Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Measured: Baseline to 12 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)
Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Measured: Baseline to 12 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)
Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Measured: Baseline to 6 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)
Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Measured: Baseline to 6 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)
Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Measured: Baseline to 12 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)
Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Measured: Baseline to 12 weeks post-discharge
Caregiver Perception of Quality of End-of-Life Care
Caregiver perception of end-of-life care will be assessed through a validated after-death bereaved family interview, evaluating healthcare utilization, quality of care, symptom management, and goal attainment.
Measured: Up to 12 weeks
Change in Caregiver Short Form ZARIT Burden Interview (ZBI-12) Score from Baseline to Week 6 (Arm 1)
Assessed by the Short Form ZARIT Burden Interview, a 12-item measure rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Nearly always." A total scores range is 0 to 48 with a higher score indicating higher caregiver burden.
Measured: Baseline to 6 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 6 (Arm 2)
Assessed by the Short Form ZARIT Burden Interview, a 12-item measure rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Nearly always." A total scores range is 0 to 48 with a higher score indicating higher caregiver burden.
Measured: Baseline to 6 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 1)
Assessed by the Short Form ZARIT Burden Interview, a 12-item measure rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Nearly always." A total scores range is 0 to 48 with a higher score indicating higher caregiver burden.
Measured: Baseline to 12 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 2)
Assessed by the Short Form ZARIT Burden Interview, a 12-item measure rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Nearly always." A total scores range is 0 to 48 with a higher score indicating higher caregiver burden.
Measured: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 1)
Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Measured: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)
Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Measured: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)
Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Measured: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)
Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.
Measured: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)
Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Measured: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)
Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Measured: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)
Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Measured: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)
Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.
Measured: Baseline to 12 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 1)
The Caregiver Patient Activation Survey is a 10-item survey used to measure a caregiver's knowledge, skills, confidence, and willingness to advocate for and support a patient's healthcare needs. It assesses the caregiver's ability to navigate the healthcare system, communicate with providers, manage medications, and ensure adherence to treatment plans.
Measured: Baseline to 6 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 2)
The Caregiver Patient Activation Survey is a 10-item survey used to measure a caregiver's knowledge, skills, confidence, and willingness to advocate for and support a patient's healthcare needs. It assesses the caregiver's ability to navigate the healthcare system, communicate with providers, manage medications, and ensure adherence to treatment plans.
Measured: Baseline to 6 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 1)
The Caregiver Patient Activation Survey is a 10-item survey used to measure a caregiver's knowledge, skills, confidence, and willingness to advocate for and support a patient's healthcare needs. It assesses the caregiver's ability to navigate the healthcare system, communicate with providers, manage medications, and ensure adherence to treatment plans.
Measured: Baseline to 12 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 2)
The Caregiver Patient Activation Survey is a 10-item survey used to measure a caregiver's knowledge, skills, confidence, and willingness to advocate for and support a patient's healthcare needs. It assesses the caregiver's ability to navigate the healthcare system, communicate with providers, manage medications, and ensure adherence to treatment plans.
Measured: Baseline to 12 weeks post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start12 May 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
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 Wright, MD MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936878
- Sponsor's protocol ID
- 24-523
- Other IDs
- R01CA270040-01A1
- Acronym
- BOLSTER
- Status last verified
- Jun 2026
- First submitted
- 13 Apr 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT06936878
- Acronym / sponsor ID
- BOLSTER / 24-523
- Conditions
- Gastrointestinal Cancer, Gynecologic Cancer, Advanced Cancer
- Keywords
- Gastrointestinal Cancer, Gynecologic Cancer, Advanced Cancer, Advanced Gastrointestinal Cancer, Advanced Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
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 program called Building Out Lifelines for Safety, Trust, Empowerment, and Renewal or (BOLSTER), which was designed to support participants with a gynecological or gastrointestinal cancer and new and complex care needs.
Detailed description
This multi-center, randomized trial is to test the efficacy of the BOLSTER Program and to improve participant quality of life (QOL), alleviate symptoms, reduce burden, and decrease the need for hospital care in participants with complex care needs from advanced gastrointestinal and gynecologic (GI/GYN) cancers.
The research study procedures include screening for eligibility, questionnaires, and telehealth visits.
Participation in this research study is expected to last about 12 weeks.
About 300 dyads (patients with family caregivers) are expected to participate in this research study.
The National Cancer Institute is funding this research study by providing funding.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Usual Care | No intervention | –Participants and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete: * Baseline visit * Standard-of-care oncology appointments * Access to nurse and specialist appointments * 6 week survey * 12 week survey |
| Arm 2: Bolster Program | Experimental | Behavioral: BOLSTER ProgramPatients and their care partners (a family member or loved one involved in their care) will be randomized in a 1:1 fashion and stratified by institution and cancer type and will complete: * Baseline visit * 6 telehealth sessions with a nurse for patients and their care partners * 2 brief telehealth sessions for care partners. * Access to the Bolster Program website with tailored educational materials * 6 week survey * 12 week survey |
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 |
|---|---|---|
| BOLSTER ProgramAlso: BOLSTERThis supportive care program includes six telehealth sessions led by a trained nurse to help patients with advanced gynecological or gastrointestinal cancers and their care partners build skills, manage symptoms, and cope with challenges. Two additional sessions will be help support care partners. Participants will also get access to the BOLSTER website, which offers personalized educational materials to support their well-being | Behavioural | Arm 2: Bolster Program |
Primary outcome
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1)
Time frame: Baseline to 6 weeks post-discharge
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
Change in FACT-G Score From Baseline to Week 6 (Arm 2)
Time frame: Baseline to 6 weeks post-discharge
Assessed by the FACT-G, a 27-item scale designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer. Answers are rated on a 5-point Likert scale from 0 "Not At All" to 4 "Very Much" with a total scores range of 0 to 108. Higher scores indicate better quality of life.
39 secondary outcomes
Change in FACT-G Score From Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in FACT-G Score From Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Change in Functional Assessment of Cancer Therapy-General 7 item Version (FACT-G7) Score from Baseline to Week 6 (Arm 1)
Time frame: Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)
Time frame: Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 1)
Time frame: Baseline to 6 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 2)
Time frame: Baseline to 6 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Change in Health Care Utilization from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in Health Care Utilization from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Change in Participant Hospital Anxiety and Depression (HADS) Anxiety Subscale Score from Baseline to Week 6 (Arm 1)
Time frame: Baseline to 6 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)
Time frame: Baseline to 6 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)
Time frame: Baseline to 6 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)
Time frame: Baseline to 6 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Caregiver Perception of Quality of End-of-Life Care
Time frame: Up to 12 weeks
Change in Caregiver Short Form ZARIT Burden Interview (ZBI-12) Score from Baseline to Week 6 (Arm 1)
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 6 (Arm 2)
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 1)
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 1)
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 2)
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 1)
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 2)
Time frame: Baseline to 12 weeks post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Alexi Wright, MD MPH principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BOLSTER Program in people with Gastrointestinal Cancer and Gynecologic Cancer, run by Dana-Farber Cancer Institute at 2 sites 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexi Wright, MD, MPH (617-632-2334, alexi_wright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1) (time frame: Baseline to 6 weeks post-discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.