BOLSTER: Learning New Skills to Thrive

Official title

BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers

Overview

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.

Interventions

• Behavioral BOLSTER Program
  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

Primary outcome measures

• 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]
• Change in FACT-G Score From Baseline to Week 6 (Arm 2) [Time frame: Baseline to 6 weeks post-discharge]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• Dana-Farber Cancer Institute — Boston
• The University of Texas MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06936878 · 24-523 · R01CA270040-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗