BOLSTER Program for Cancer

(BOLSTER Trial)

Recruiting at 1 trial location

Overseen By Alexi Wright, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Cognitive impairments, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program designed to assist individuals with advanced gynecological or gastrointestinal cancers who have complex care needs, such as feeding tubes or special drains. The trial aims to determine if the BOLSTER Program can provide better support for patients and their family caregivers compared to usual care. Participants will be divided into two groups: one will receive standard cancer care, while the other will receive additional support through telehealth sessions and educational resources. Eligible participants include those currently hospitalized or requiring specialized care at home, planning to continue cancer treatment, and having a caregiver willing to participate. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions that could enhance support for patients and caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BOLSTER Program is safe for participants with gynecological or gastrointestinal cancer?

Research has shown that the BOLSTER Program is practical and well-liked by patients with gynecologic and gastrointestinal cancers. This program uses technology and is led by nurses to support these patients and their caregivers. Studies have found that participants respond positively to the program, indicating it is safe and easy to handle. Importantly, no reports of serious side effects have emerged from the program. This suggests it is a safe choice for those considering joining a clinical trial that includes the BOLSTER Program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BOLSTER Program for cancer care because it aims to enhance support for patients and their care partners through personalized telehealth sessions. Unlike standard care that primarily involves regular oncology appointments and access to healthcare professionals, the BOLSTER Program offers six dedicated telehealth sessions with nurses, plus two additional sessions specifically for care partners. Additionally, participants gain access to a specialized website with tailored educational materials. This comprehensive approach not only focuses on the patient but also empowers care partners, potentially improving overall care experiences and outcomes.

What evidence suggests that the BOLSTER Program is effective for supporting patients with gynecological or gastrointestinal cancer?

Research has shown that the BOLSTER Program, a treatment arm in this trial, may benefit individuals with gynecological or gastrointestinal cancer. One study found that patients in the BOLSTER Program reported significant improvements in quality of life and increased confidence in managing their care. Most patients and caregivers expressed high satisfaction with the program. Many also found it helpful for understanding treatment and care options. While these results are promising, they rely on patient reports, indicating potential benefits of the program. ^{3 4 6 7 8}

Who Is on the Research Team?

Alexi Wright, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced gastrointestinal or gynecologic cancers who have complex care needs like ostomies or catheters. They must be receiving ongoing cancer treatment, speak English or Spanish, and have a caregiver willing to participate. Those with cognitive impairments, planning hospice care, unable to consent, prisoners, or minors cannot join.

Inclusion Criteria

Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound VAC)

Has a family caregiver or friend (hereafter designated family caregiver) willing to participate

I am in the hospital needing skilled care or I need new skilled care as an outpatient.

Exclusion Criteria

Has cognitive impairments (as determined by the patient's oncologist)

Planning to enroll in hospice

Unable to complete baseline survey

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (telehealth)

Treatment

Participants engage in the BOLSTER program, including telehealth sessions and access to educational materials

12 weeks

6 telehealth sessions with a nurse, 2 brief telehealth sessions for care partners

Follow-up

Participants are monitored for quality of life and symptom management

4 weeks

2 visits (telehealth)

What Are the Treatments Tested in This Trial?

Interventions

• BOLSTER Program

Trial Overview The BOLSTER program is being tested in this study. It's designed to help people with gynecological or gastrointestinal cancer manage new and complex care needs by providing support systems that aim to improve their quality of life during treatment.

How Is the Trial Designed?

Group I: Arm 2: Bolster Program Experimental Treatment 1 Intervention

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

Group II: Arm 1: Usual Care Active Control 1 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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The ActivOnco model of care, which includes exercise prescription and rehabilitation screening, effectively improves the quality of life for cancer survivors, as demonstrated by assessments of 1635 patients and exercise prescriptions for 1066 participants from 2011 to 2015.

While exercise is beneficial, it is not a complete solution for all functional declines related to cancer and its treatment, highlighting the need for comprehensive support and resources to address the diverse rehabilitation needs of cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation and exercise oncology program: translating research into a model of care. Dalzell, MA., Smirnow, N., Sateren, W., et al.[2019]

In the ICON8 ovarian cancer clinical trial, 51,019 adverse events were reported, but only 61% of serious adverse events were matched to existing adverse events, indicating a significant gap in safety reporting.

Re-analyzing safety data by including serious adverse events increased the detection of grade 3 or worse safety events, highlighting the importance of comprehensive safety data collection for accurate risk assessment in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. James, EC., Dunn, D., Cook, AD., et al.[2021]

A survey of 125 cancer cooperative groups across 58 countries revealed that while most do not have formal policies for using real-world data (RWD), a significant majority have previously conducted studies utilizing RWD for both exploratory and confirmatory purposes.

Despite their experience with RWD, these groups primarily focus on traditional clinical trials, indicating a need for greater understanding and expertise in RWD methodologies, as well as a recognition of its potential benefits like lower costs and larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world data in oncology: a questionnaire-based analysis of the academic research landscape examining the policies and experiences of the cancer cooperative groups. Saesen, R., Lacombe, D., Huys, I.[2023]

A review of 81 clinical trials involving over 45,000 patients revealed that the reporting of adverse events (AEs) for targeted therapies and immunotherapies is often inadequate, particularly regarding recurrent/late toxicities and the duration of AEs.

The study highlights that more than 90% of trials failed to adequately report the timing and occurrence of all-grade AEs, indicating a need for improved transparency and detail in AE reporting in future oncology trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy. Bossi, P., Botta, L., Bironzo, P., et al.[2020]

In a study of 322,887 cancer patients undergoing treatment, 19% experienced oncology-specific adverse events, with higher rates in those with metastatic cancers (41% for colorectal and 50% for lung cancer).

The most common triggers for these adverse events included abnormal serum bicarbonate levels and blood transfusions, highlighting the need for targeted monitoring in cancer care to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. Weingart, SN., Nelson, J., Koethe, B., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9492907/

Developing and Field Testing BOLSTER: A Nurse-Led ... Preliminary acceptability and perceived effectiveness​​ Two of three (67%) patients and 2/4 (50%) caregivers agreed BOLSTER helped the patient understand and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06936878

NCT06936878 | BOLSTER: Learning New Skills to Thrive 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 ...

3. cancernetwork.com cancernetwork.com/view/patient-reported-outcomes-bolster-breast-cancer-treatment

Patient-Reported Outcomes Bolster Breast Cancer Treatment The findings show that patient-reported outcome measures (PROMs) could be of most benefit if standardized across healthcare, despite the ...

4. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(24)00275-0/fulltext

Feasibility and acceptability of a nurse-led telehealth ... We consented 77% of approached patients. In the BOLSTER arm, 91.0% of patients and 100.0% of caregivers were satisfied. Compared to EDP, more ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825824002750

Feasibility and acceptability of a nurse-led telehealth ... Patients in the BOLSTER arm experienced clinically meaningful improvements in quality of life and self-efficacy. Patients in the BOLSTER arm had more advance ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-00224

BOLSTER Intervention in Improving Quality of Life ... This clinical trial studies how well the Building Out Lifelines for Safety, Trust, Empowerment and Renewal (BOLSTER) intervention works in improving quality ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03367247

Study Details | NCT03367247 | BOLSTER: Building Out ... This research study is evaluating a new intervention, BOLSTER, which was designed to provide more support for patients with gynecologic and gastrointestinal ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.39.28_suppl.187

Development, feasibility, and acceptability of the BOLSTER ... BOLSTER is a technology-enhanced, nurse-led care management intervention that is feasible and acceptable to patients with GYN cancer-associated PC and their ...