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| ID | Type | Description | Link |
|---|---|---|---|
| CA166210 | Other Identifier | NCI | |
| R21CA223684 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research study is evaluating a new intervention, BOLSTER, which was designed to provide more support for patients with gynecologic and gastrointestinal cancers and their caregivers after a hospitalization.
Hospitalizations can be difficult for patients with cancer, especially when they are transitioning home. Patients and caregivers are often expected to perform complex medical and nursing tasks with little or no preparation. Patients and caregivers report high levels of unmet needs for information about how best to manage symptoms and new medical procedures (such as managing new tubes, lines or drains).
The study team has developed a research project which aims to address these needs. If a patient agrees to participate in the study, she will take part in a program called BOLSTER (Building Out Lifelines for Safety, Trust, Empowerment and Renewal). BOLSTER will provide patients and caregivers with education and skills training, symptom management, and support across care settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolster | Experimental |
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| Enhanced Discharge Planning (EDP) | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOLSTER | Behavioral | BOLSTER provides patients and caregivers with education and skills training, symptom management, and support across care settings over a four-week period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the BOLSTER Intervention | ≥50% consent-to-approach ratio | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the BOLSTER Intervention | ≥70% participants "agree" or "strongly agree" that they would recommend BOLSTER to other patients; and ≥70% participants "agreed or "strongly agreed" that they were satisfied with the BOLSTER intervention. Note that this measure only includes data from the RCT portion of the study, as the Phases 1a and 1b were designed to refine the intervention. | 3 months |
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Patient inclusion criteria
Patient exclusion criteria
Caregiver inclusion criteria
Caregiver exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexi A Wright, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35297744 | Background | Pozzar RA, Enzinger AC, Poort H, Furey A, Donovan H, Orechia M, Thompson E, Tavormina A, Fenton ATHR, Jaung T, Braun IM, DeMarsh A, Cooley ME, Wright AA. Developing and Field Testing BOLSTER: A Nurse-Led Care Management Intervention to Support Patients and Caregivers following Hospitalization for Gynecologic Cancer-Associated Peritoneal Carcinomatosis. J Palliat Med. 2022 Sep;25(9):1367-1375. doi: 10.1089/jpm.2021.0618. Epub 2022 Mar 17. | |
| 38851039 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase Ia: 10-week Pre-pilot Patients | In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. |
| FG001 | Phase Ia: 10-week Pre-pilot Caregivers | In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. |
| FG002 | Phase Ib: 4-week Pre-pilot Patients | The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. |
| FG003 | Phase Ib: 4-week Pre-pilot Caregivers | The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. |
| FG004 | Phase II (RCT): BOLSTER Arm Patients | BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. |
| FG005 | Phase II (RCT): BOLSTER Arm Caregivers | BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. |
| FG006 | Phase II (RCT): EDP Arm Patients | Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call. |
| FG007 | Phase II (RCT): EDP Arm Caregivers | Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase Ia: 10-week Pre-pilot Patients | In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the BOLSTER Intervention | ≥50% consent-to-approach ratio | Posted | Count of Participants | Participants | 1 month |
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Adverse event data were collected for 2 months while patients were on study, since this is a minimal risk study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase Ia: 10-week Pre-pilot Patients | In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexi Wright | Dana-Farber Cancer Institute | 617-632-2334 | alexi_wright@dfci.harard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2023 | Mar 20, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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Phase I: Single-arm study with up to 20 ovarian cancer patients and their informal caregivers run-in.
Phase II: Two-arm pilot RCT with 60 gynecologic or gastrointestinal cancer patients and their informal caregivers (30 dyads in each arm).
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Clinical research assistant blinded to randomized study arms; will conduct structured interview at baseline, prior to randomization, and 4 weeks post randomization +/- 2 weeks.
| Enhanced Discharge Planning (EDP) | Other | EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. |
|
| Pozzar RA, Enzinger AC, Howard C, Tavormina A, Matulonis UA, Campos S, Liu JF, Horowitz N, Konstantinopoulos PA, Krasner C, Wall JA, Sciacca K, Meyer LA, Lindvall C, Wright AA. Feasibility and acceptability of a nurse-led telehealth intervention (BOLSTER) to support patients with peritoneal carcinomatosis and their caregivers: A pilot randomized clinical trial. Gynecol Oncol. 2024 Sep;188:1-7. doi: 10.1016/j.ygyno.2024.06.001. Epub 2024 Jun 7. |
| BG001 | Phase Ia: 10-week Pre-pilot Caregivers | In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. |
| BG002 | Phase Ib: 4-week Pre-pilot Patients | The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. |
| BG003 | Phase Ib: 4-week Pre-pilot Caregivers | The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. |
| BG004 | Phase II (RCT): BOLSTER Arm Patients | BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. |
| BG005 | Phase II (RCT): BOLSTER Arm Caregivers | BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. |
| BG006 | Phase II (RCT): EDP Arm Patients | Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call. |
| BG007 | Phase II (RCT): EDP Arm Caregivers | Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call. |
| BG008 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Ethnicity | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Highest Level of Education | Count of Participants | Participants |
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| Secondary | Acceptability of the BOLSTER Intervention | ≥70% participants "agree" or "strongly agree" that they would recommend BOLSTER to other patients; and ≥70% participants "agreed or "strongly agreed" that they were satisfied with the BOLSTER intervention. Note that this measure only includes data from the RCT portion of the study, as the Phases 1a and 1b were designed to refine the intervention. | Posted | Count of Participants | Participants | 3 months |
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| 3 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Phase Ia: 10-week Pre-pilot Caregivers | In this single arm pre-pilot, patients and caregiver dyads were offered a total of 12 contacts with a BOLSTER study nurse over 10 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Phase Ib: 4-week Pre-pilot Patients | The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | Phase Ib: 4-week Pre-pilot Caregivers | The second, abbreviated iteration of the intervention consisted of a single arm pre-pilot, in which patient and caregiver dyads were offered a total of 6 contacts with a BOLSTER study nurse over 4 weeks and daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. Participants also had access to web-based symptom management and medical skills training. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | Phase II (RCT): BOLSTER Arm Patients | BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. | 5 | 29 | 0 | 29 | 0 | 29 |
| EG005 | Phase II (RCT): BOLSTER Arm Caregivers | BOLSTER provides participants with longitudinal nursing support across care settings, a smartphone-based symptom management app, a print and web-based symptom management toolkit, and advance care planning to ensure that the patient receives care that is congruent with her informed preferences. BOLSTER includes a total of 6 contacts with a study nurse over 4 weeks. Daily contact via a smartphone-based symptom app which queries patients about their symptoms using questions from the PRO-CTCAE, risk-stratifies their symptoms, and provides tailored symptom management advice. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG006 | Phase II (RCT): EDP Arm Patients | Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call. | 3 | 32 | 0 | 32 | 0 | 32 |
| EG007 | Phase II (RCT): EDP Arm Caregivers | Enhanced Discharge Planning (EDP): EDP provides patients and caregivers a single session of education and skills training, symptom management, and support. The EDP participants received medication education, self-management strategies for symptoms, skills training, and a list of red flag symptoms and numbers for who to call. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D005767 |
| Gastrointestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Neither agree nor disagree |
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| Acceptability - "I would recommend the BOLSTER program to other patients..." |
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