[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06936878":3,"trial-entities:NCT06936878":215,"trial-summary:NCT06936878":230},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":48,"sex":139,"minimum_age":140,"maximum_age":141,"healthy_volunteers":142,"eligibility_criteria":143,"std_ages":166,"locations":169,"central_contacts":203,"overall_officials":210,"references":213,"see_also_links":214},"NCT06936878","24-523","BOLSTER: Learning New Skills to Thrive","BOLSTER: Strengthening Patient and Caregiver Supports in Advanced Gynecologic and Gastrointestinal Cancers","RECRUITING","2028-07-31","2026-06","2026-06-18","2025-05-12","Dana-Farber Cancer Institute","OTHER",true,"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.","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\u002FGYN) cancers.\n\nThe research study procedures include screening for eligibility, questionnaires, and telehealth visits.\n\nParticipation in this research study is expected to last about 12 weeks.\n\nAbout 300 dyads (patients with family caregivers) are expected to participate in this research study.\n\nThe National Cancer Institute is funding this research study by providing funding.",[19,20,21],"Gastrointestinal Cancer","Gynecologic Cancer","Advanced Cancer",[19,20,21,23,24],"Advanced Gastrointestinal Cancer","Advanced Gynecologic Cancer","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[28],"NA",{"count":30,"type":31},600,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"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",[38],"Arm 2: Bolster Program",[40],"BOLSTER",[42,46],{"measure":43,"description":44,"timeFrame":45},"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.","Baseline to 6 weeks post-discharge",{"measure":47,"description":44,"timeFrame":45},"Change in FACT-G Score From Baseline to Week 6 (Arm 2)",[49,52,54,57,59,61,63,66,68,71,73,76,78,81,83,86,88,90,92,95,97,99,101,105,108,110,112,114,116,118,120,122,124,126,128,130,133,135,137],{"measure":50,"description":44,"timeFrame":51},"Change in FACT-G Score From Baseline to Week 12 (Arm 1)","Baseline to 12 weeks post-discharge",{"measure":53,"description":44,"timeFrame":51},"Change in FACT-G Score From Baseline to Week 12 (Arm 2)",{"measure":55,"description":56,"timeFrame":45},"Change in Functional Assessment of Cancer Therapy-General 7 item Version (FACT-G7) Score from Baseline to Week 6 (Arm 1)","Assessed by the FACT-G7, a 7-item designed to measure physical, emotional, social, functional, and family well-being in patients with life-limiting cancer in the past 7 days. 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 28. A higher score indicates better quality of life.",{"measure":58,"description":56,"timeFrame":45},"Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)",{"measure":60,"description":56,"timeFrame":51},"Change in FACT-G7 Score from Baseline to Week 12 (Arm 1)",{"measure":62,"description":56,"timeFrame":51},"Change in FACT-G7 Score from Baseline to Week 12 (Arm 2)",{"measure":64,"description":65,"timeFrame":45},"Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 1)","Assessed by the Self-Efficacy for Managing Chronic Conditions - Short Form 4a, an 8-item measure for determining managements of symptoms and medications. Answers are rated on a 5-point Likert scale from 1 \"I am not at all confident\" to 5 \"I am very confident\" with a total scores range of 0 to 40. A higher score indicates greater self-efficacy.",{"measure":67,"description":65,"timeFrame":45},"Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 6 (Arm 2)",{"measure":69,"description":70,"timeFrame":51},"Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 1)","Assessed by the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Care Needs and Managing Medications and Treatment. The Managing Care Needs (7 items) and Managing Medications and Treatment - Short Form 4a (6 items) evaluate confidence in handling medical care, including managing devices, medications, and symptoms. Responses are rated on a 5-point Likert scale from 1 (\"Not at all confident\") to 5 (\"Very confident\"), with higher scores indicating greater self-efficacy.",{"measure":72,"description":70,"timeFrame":51},"Change in Participant Self-Efficacy for Managing Chronic Conditions Score from Baseline to Week 12 (Arm 2)",{"measure":74,"description":75,"timeFrame":51},"Change in Health Care Utilization from Baseline to Week 12 (Arm 1)","Defined as the numeric value of the frequency of health care utilization by participant and collected by the Health Care Utilization Report, which is a log that covers the previous 12 weeks and collects emergency room visits, hospitalizations, and rehabilitation admissions.",{"measure":77,"description":75,"timeFrame":51},"Change in Health Care Utilization from Baseline to Week 12 (Arm 2)",{"measure":79,"description":80,"timeFrame":51},"Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 1)","ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.",{"measure":82,"description":80,"timeFrame":51},"Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 2)",{"measure":84,"description":85,"timeFrame":45},"Change in Participant Hospital Anxiety and Depression (HADS) Anxiety Subscale Score from Baseline to Week 6 (Arm 1)","Assessed by the Anxiety Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for anxiety.",{"measure":87,"description":85,"timeFrame":45},"Change in Participant HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)",{"measure":89,"description":85,"timeFrame":51},"Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)",{"measure":91,"description":85,"timeFrame":51},"Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)",{"measure":93,"description":94,"timeFrame":45},"Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)","Assessed by the Depression Subscale of the HADS questionnaire, a 7-item survey with answers scored on a 0-3 point scale. A total scores range is 0 - 21 with a higher score indicating increasing abnormality (or caseness) for depression.",{"measure":96,"description":94,"timeFrame":45},"Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)",{"measure":98,"description":94,"timeFrame":51},"Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)",{"measure":100,"description":94,"timeFrame":51},"Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)",{"measure":102,"description":103,"timeFrame":104},"Caregiver Perception of Quality of End-of-Life Care","Caregiver perception of end-of-life care will be assessed through a validated after-death bereaved family interview, evaluating healthcare utilization, quality of care, symptom management, and goal attainment.","Up to 12 weeks",{"measure":106,"description":107,"timeFrame":45},"Change in Caregiver Short Form ZARIT Burden Interview (ZBI-12) Score from Baseline to Week 6 (Arm 1)","Assessed by the Short Form ZARIT Burden Interview, a 12-item measure rated on a 5-point Likert scale with answers ranging from 0 \"Never\" to 4 \"Nearly always.\" A total scores range is 0 to 48 with a higher score indicating higher caregiver burden.",{"measure":109,"description":107,"timeFrame":45},"Change in Caregiver ZBI-12 Score from Baseline to Week 6 (Arm 2)",{"measure":111,"description":107,"timeFrame":51},"Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 1)",{"measure":113,"description":107,"timeFrame":51},"Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 2)",{"measure":115,"description":85,"timeFrame":45},"Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 1)",{"measure":117,"description":85,"timeFrame":45},"Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)",{"measure":119,"description":85,"timeFrame":51},"Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)",{"measure":121,"description":85,"timeFrame":51},"Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)",{"measure":123,"description":94,"timeFrame":45},"Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)",{"measure":125,"description":94,"timeFrame":45},"Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)",{"measure":127,"description":94,"timeFrame":51},"Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)",{"measure":129,"description":94,"timeFrame":51},"Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)",{"measure":131,"description":132,"timeFrame":45},"Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 1)","The Caregiver Patient Activation Survey is a 10-item survey used to measure a caregiver's knowledge, skills, confidence, and willingness to advocate for and support a patient's healthcare needs. It assesses the caregiver's ability to navigate the healthcare system, communicate with providers, manage medications, and ensure adherence to treatment plans.",{"measure":134,"description":132,"timeFrame":45},"Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 2)",{"measure":136,"description":132,"timeFrame":51},"Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 1)",{"measure":138,"description":132,"timeFrame":51},"Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 2)","ALL","18 Years",null,false,{"inclusion":144,"exclusion":158,"raw_text":165},[145,146,147,148,149,150,151,152,153,154,155,156,157],"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\u002Fphysical ability to participate in a 60-minute interview","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",[159,160,161,162,163,164,161,162,163,164],"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","Participant Inclusion Criteria:\n\n* Age ≥18 years\n* Currently hospitalized with skilled care need or have acquired a new skilled care need as an outpatient\n* Diagnosed with advanced gastrointestinal cancer (esophageal, gastric, pancreatic, hepatobiliary, colorectal, unknown GI primary, anal) or advanced gynecologic cancer (ovarian, endometrial, cervical, vaginal, vulvar)\n* Has a complex care need (e.g., ostomy, ileostomy, urostomy, nephrostomy, biliary drain, venting gastric tube, feeding tube, intraabdominal or pleural catheter, wound VAC)\n* Plans to receive ongoing cancer treatment\n* Has a family caregiver or friend (hereafter designated family caregiver) willing to participate\n* Able to speak and read English or Spanish (self-report)\n* Are willing to be audio-recorded\n* Have the cognitive\u002Fphysical ability to participate in a 60-minute interview\n\nFamily or Caregiver Inclusion Criteria:\n\n* Age ≥ 18 years\n* Identified by a patient (as defined above) as a family or friend who is involved in their care.\n* Willing to participate in study visits\n* Willing to be audio recorded\n\nParticipant Exclusion Criteria:\n\n* Has cognitive impairments (as determined by the patient's oncologist)\n* Planning to enroll in hospice\n* Unable to complete baseline survey\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n\nFamily or Caregiver Exclusion Criteria:\n\n* Unable to complete baseline survey\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners",[167,168],"ADULT","OLDER_ADULT",[170,186],{"facility":13,"status":8,"city":171,"state":172,"zip":173,"country":174,"contacts":175,"geoPoint":183},"Boston","Massachusetts","02215","United States",[176,181],{"name":177,"role":178,"phone":179,"email":180},"Alexi Wright, MD, MPH","CONTACT","617-632-2334","Alexi_Wright@dfci.harvard.edu",{"name":177,"role":182},"PRINCIPAL_INVESTIGATOR",{"lat":184,"lon":185},42.35843,-71.05977,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":174,"contacts":191,"geoPoint":200},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",[192,196],{"name":193,"role":178,"phone":194,"email":195},"Larissa Meyer, MD","713-745-0973","lmeyer@mdanderson.org",{"name":197,"role":178,"phone":198,"email":199},"Maria Iniesta-Donate, MD, PhD","281-928-9892","miniesta@mdanderson.org",{"lat":201,"lon":202},29.76328,-95.36327,[204,206],{"name":177,"role":178,"phone":179,"email":205},"alexi_wright@dfci.harvard.edu",{"name":207,"role":178,"phone":208,"email":209},"Irene Wang, MPH","617-582-7238","irene_wang@dfci.harvard.edu",[211],{"name":212,"affiliation":13,"role":182},"Alexi Wright, MD MPH",[],[],{"nct_id":4,"conditions":216,"biomarkers":229},[217,218,219,220,221,222,223,224,225,226,227,228],"Anal Carcinoma","Cervical Carcinoma","Colorectal Carcinoma","Endometrial Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Hepatobiliary Cancer","Malignant Ovarian Neoplasm","Pancreatic Carcinoma","Solid Neoplasm","Vaginal Carcinoma","Vulvar Carcinoma",[],{"nct_id":4,"found":15,"summary":231,"prompt_version":239},{"design":232,"status":233,"heading":6,"summary":234,"follow_up":232,"word_count":235,"commitments":236,"compensation":237,"drugs_mentioned":238},"Not specified.","completed","{\n   \"BOLSTER: Learning New Skills for Advanced Cancer\",\n   \"This study is testing a program called BOLSTER, which helps people with advanced gynecological or gastrointestinal (GI) cancers and their care partners. The BOLSTER program involves six telehealth sessions led by a nurse to help you and your care partner learn skills, manage symptoms, and cope with challenges. Care partners will have two additional sessions. Researchers want to see if BOLSTER can improve your quality of life. You may be able to join if you are 18 or older, have advanced GI or gynecologic cancer, and have a new or complex care need. The study is currently unclear on its recruitment status and plans to enroll about 600 people.\",\n  \"design\": \"This is a multi-center, randomized study, meaning participants are assigned by chance to different groups. About 300 patient-caregiver pairs are expected to participate.\",\n  \"commitments\": \"You will participate in screening, complete questionnaires, and have telehealth visits. Your participation in this study is expected to last about 12 weeks.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Your quality of life will be measured from the start of the study to 6 weeks after discharge.\",\n}",192,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]