An interventional study of BOLSTER Program in Gastrointestinal Cancer, Gynecologic Cancer and Advanced Cancer, sponsored by Dana-Farber Cancer Institute. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Health services research
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/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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's planned enrollment of 600 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 813 studies on the registry; 124 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 77 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participant Inclusion Criteria:
Family or Caregiver Inclusion Criteria:
Participant Exclusion Criteria:
Family or Caregiver Exclusion Criteria:
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
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
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
Also known as: BOLSTER
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
Change in FACT-G Score From Baseline to Week 12 (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 12 weeks post-discharge
Change in FACT-G Score From Baseline to Week 12 (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 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)
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.
Time frame: Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)
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.
Time frame: Baseline to 6 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 12 (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.
Time frame: Baseline to 12 weeks post-discharge
Change in FACT-G7 Score from Baseline to Week 12 (Arm 2)
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.
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)
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.
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)
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.
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)
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.
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)
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.
Time frame: Baseline to 12 weeks post-discharge
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.
Time frame: Baseline to 12 weeks post-discharge
Change in Health Care Utilization from Baseline to Week 12 (Arm 2)
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.
Time frame: Baseline to 12 weeks post-discharge
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.
Time frame: Baseline to 12 weeks post-discharge
Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 2)
ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.
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)
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (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.
Time frame: Baseline to 12 weeks post-discharge
Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)
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.
Time frame: Baseline to 12 weeks post-discharge
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (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.
Time frame: Baseline to 12 weeks post-discharge
Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)
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.
Time frame: Baseline to 12 weeks post-discharge
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.
Time frame: Up to 12 weeks
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 6 (Arm 2)
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (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.
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 2)
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.
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver 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.
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (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.
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)
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.
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver 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.
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (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.
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)
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.
Time frame: Baseline to 12 weeks post-discharge
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 2)
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.
Time frame: Baseline to 6 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 12 (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.
Time frame: Baseline to 12 weeks post-discharge
Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 2)
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.
Time frame: Baseline to 12 weeks post-discharge
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Sap
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