BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers
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.
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.
Arms & interventions
- BehavioralBOLSTER 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
Outcome measures
Primary
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.
Time frame: 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.
Time frame: Baseline to 6 weeks post-discharge
Secondary
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
Eligibility criteria
Study locations (2)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030