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NCT Number: NCT06936878

BOLSTER: Learning New Skills to Thrive

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.

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Key information

Conditions

Gastrointestinal Cancer Advanced Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gynecologic Cancer Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BOLSTER Program

Behavioral

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

Other names: BOLSTER

Primary outcomes

  1. 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

    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.

  2. Change in FACT-G Score From Baseline to Week 6 (Arm 2)

    Time frame: 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.

Secondary outcomes

  1. Change in FACT-G Score From Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 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.

  2. Change in FACT-G Score From Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 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.

  3. 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

    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.

  4. Change in FACT-G7 Score from Baseline to Week 6 (Arm 2)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  5. Change in FACT-G7 Score from Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  6. Change in FACT-G7 Score from Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  7. 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

    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.

  8. 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

    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.

  9. 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

    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.

  10. 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

    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.

  11. Change in Health Care Utilization from Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  12. Change in Health Care Utilization from Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  13. Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 weeks post-discharge

    ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.

  14. Change in Advanced care planning (ACP) from Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 weeks post-discharge

    ACP measures a patient's preferences, understanding, and preparedness for future medical care, as documented in the electronic health record.

  15. 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

    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.

  16. Change in Participant HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  17. Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  18. Change in Participant HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  19. Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  20. Change in Participant HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  21. Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  22. Change in Participant HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  23. Caregiver Perception of Quality of End-of-Life Care

    Time frame: Up to 12 weeks

    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.

  24. 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

    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.

  25. Change in Caregiver ZBI-12 Score from Baseline to Week 6 (Arm 2)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  26. Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  27. Change in Caregiver ZBI-12 Score from Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  28. Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 1)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  29. Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 6 (Arm 2)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  30. Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  31. Change in Caregiver HADS Anxiety Subscale Score from Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  32. Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 1)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  33. Change in Caregiver HADS Depression Subscale Score from Baseline to Week 6 (Arm 2)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  34. Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  35. Change in Caregiver HADS Depression Subscale Score from Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  36. Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 1)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  37. Change in Caregiver-Patient Activation from Baseline to Week 6 (Arm 2)

    Time frame: Baseline to 6 weeks post-discharge

    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.

  38. Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 1)

    Time frame: Baseline to 12 weeks post-discharge

    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.

  39. Change in Caregiver-Patient Activation from Baseline to Week 12 (Arm 2)

    Time frame: Baseline to 12 weeks post-discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexi Wright, MD, MPH

CONTACT

[email protected]

617-632-2334

Irene Wang, MPH

CONTACT

[email protected]

617-582-7238

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: BOLSTER

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 20, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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