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

Trial Summary

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 data supports the effectiveness of the BOLSTER Program treatment for cancer?

Research shows that patient education programs and psycho-educational care can help improve the well-being of cancer patients, suggesting that similar approaches in the BOLSTER Program might be beneficial. Additionally, physical activity interventions have been found to positively impact cancer-related issues, which could be a component of the BOLSTER Program. ^{1 2 3 4 5}

What safety data exists for the BOLSTER Program for Cancer treatment?

Safety data in cancer clinical trials often includes adverse events (unwanted side effects) and serious adverse events, but there is a concern about under-reporting of harm. Real-world data and patient-reported assessments are suggested to improve understanding of treatment safety. ^{6 7 8 9 10}

How does the BOLSTER Program treatment for cancer differ from other treatments?

The BOLSTER Program is unique because it focuses on community-based exercise and rehabilitation to improve the quality of life for cancer patients, unlike traditional treatments that primarily focus on medical interventions. It emphasizes a holistic approach by integrating exercise and supportive care, which is not commonly found in standard cancer treatments. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Alexi Wright, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Patient education programs for cancer-related fatigue: A systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Safety, feasibility, and effectiveness of implementing supervised exercise into the clinical care of individuals with advanced cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Cancer-related fatigue management: evaluation of a patient education program with a large-scale randomised controlled trial, the PEPs fatigue study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Development of a computer-tailored physical activity intervention for prostate and colorectal cancer patients and survivors: OncoActive. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Psycho-educational care for adults with cancer. [2019]

6. England 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. [2023]

7. England 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Under-reporting of harm in clinical trials. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Systematic Review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Model for a community-based exercise program for cancer survivors: taking patient care to the next level. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Rehabilitation and exercise oncology program: translating research into a model of care. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

What are the attitudes and beliefs of oncologists regarding potential cancer rehabilitation in a tertiary cancer center? [2020]

14. Germany pubmed.ncbi.nlm.nih.gov

Developing a free supportive care program for cancer patients within an integrative medicine clinic. [2018]

15. Canada pubmed.ncbi.nlm.nih.gov

Making cancer bearable: the Interlink Community Cancer Nurses model of supportive care. [2019]