BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 2: Bolster Program
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
干预措施: BOLSTER Program (Behavioral)
Arm 1: Usual Care
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
结局指标
主要结局
Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score from Baseline to Week 6 (Arm 1)
时间窗: 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)
时间窗: 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.
次要结局
- Change in FACT-G Score From Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in FACT-G Score From Baseline to Week 12 (Arm 2)(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)(Baseline to 6 weeks post-discharge)
- Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)(Baseline to 6 weeks post-discharge)
- Change in FACT-G7 Score from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in FACT-G7 Score from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
- Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 1)(Baseline to 6 weeks post-discharge)
- Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 2)(Baseline to 6 weeks post-discharge)
- Change in Health Care Utilization from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
- Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
- Change in Health Care Utilization from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in Participant Hospital Anxiety and Depression (HADS) Anxiety Subscale Score from Baseline to Week 6 (Arm 1)(Baseline to 6 weeks post-discharge)
- Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
- Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)(Baseline to 6 weeks post-discharge)
- Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
- Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in Participant HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)(Baseline to 6 weeks post-discharge)
- Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
- Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)(Baseline to 6 weeks post-discharge)
- Caregiver Perception of Quality of End-of-Life Care(Up to 12 weeks)
- Change in Caregiver Short Form ZARIT Burden Interview (ZBI-12) Score from Baseline to Week 6 (Arm 1)(Baseline to 6 weeks post-discharge)
- Change in Caregiver ZBI-12 Score from Baseline to Week 6 (Arm 2)(Baseline to 6 weeks post-discharge)
- Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
- Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 1)(Baseline to 6 weeks post-discharge)
- Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)(Baseline to 6 weeks post-discharge)
- Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
- Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)(Baseline to 6 weeks post-discharge)
- Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)(Baseline to 6 weeks post-discharge)
- Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
- Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 1)(Baseline to 6 weeks post-discharge)
- Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 2)(Baseline to 6 weeks post-discharge)
- Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 1)(Baseline to 12 weeks post-discharge)
- Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 2)(Baseline to 12 weeks post-discharge)
研究者
Alexi A. Wright, MD
Principal Investigator
Dana-Farber Cancer Institute