Gastrointestinal Cancer, Gynecologic Cancer
Conditions
Keywords
Ovarian Cancer, Bowel blockage, Ascites, Supportive care, Nursing, Mobile health, m-Health, Tele-health, Palliative Care, Symptom management, Gastrointestinal Cancer, Gynecologic Cancer, Complex Care Needs
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALBOLSTER
BOLSTER provides patients and caregivers with education and skills training, symptom management, and support across care settings over a four-week period.
OTHEREnhanced Discharge Planning (EDP)
EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical research assistant blinded to randomized study arms; will conduct structured interview at baseline, prior to randomization, and 4 weeks post randomization +/- 2 weeks.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient inclusion criteria * Adults (≥18 years old); * GYN or GI cancers receiving anti-neoplastic therapy; * Hospitalized, recently hospitalized (i.e. within the first 2 visits after a hospitalization), or recent outpatient placement of tube, line, or drain (e.g. PleurX catheter); * Plan to receive ongoing care at DFCI; * Willingness to be audio taped for the study (for monitoring of study fidelity). * Have complex care needs (e.g. an ostomy, ileostomy, a gastric tube, percutaneous nephrostomy tubes, a PleurX catheter, or need for total parenteral nutrition) Patient
Exclusion criteria
* Unable to read and respond to questions in English; * Cognitive impairment; * Unable to complete the baseline interview; * Plan for immediate hospice referral Caregiver inclusion criteria * Adults (≥18 years old); * Family member or friend of an eligible patient; * Willingness to be audio taped for the study (for monitoring of study fidelity); * Willingness to participate in study visits Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the BOLSTER Intervention | 1 month | ≥50% consent-to-approach ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the BOLSTER Intervention | 3 months | ≥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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlexi A Wright, MD, MPH
Dana-Farber Cancer Institute
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| 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. | 6 |
| 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. | 5 |
| 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. | 4 |
| 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. | 29 |
| 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. | 17 |
| 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. | 32 |
| 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. | 22 |
| Total | 121 |
Baseline characteristics
| Characteristic | Phase Ib: 4-week Pre-pilot Patients | Total | Phase II (RCT): EDP Arm Caregivers | Phase II (RCT): EDP Arm Patients | Phase Ia: 10-week Pre-pilot Caregivers | Phase Ia: 10-week Pre-pilot Patients | Phase II (RCT): BOLSTER Arm Caregivers | Phase II (RCT): BOLSTER Arm Patients | Phase Ib: 4-week Pre-pilot Caregivers |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 14.03 | 61 years STANDARD_DEVIATION 9.46 | 60 years STANDARD_DEVIATION 10.21 | 62 years STANDARD_DEVIATION 7.51 | 64 years STANDARD_DEVIATION 6.63 | 64 years STANDARD_DEVIATION 7.31 | 59 years STANDARD_DEVIATION 9.54 | 60 years STANDARD_DEVIATION 10.17 | 62 years STANDARD_DEVIATION 12.48 |
| Ethnicity Hispanic or LatinX | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Ethnicity Missing | 0 Participants | 5 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity Not Hispanic or LatinX | 5 Participants | 112 Participants | 21 Participants | 27 Participants | 6 Participants | 6 Participants | 16 Participants | 27 Participants | 4 Participants |
| Highest Level of Education 8th grade or less | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Highest Level of Education 9 - 11th grade | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Highest Level of Education Advanced degree | 0 Participants | 52 Participants | 7 Participants | 14 Participants | 3 Participants | 2 Participants | 11 Participants | 14 Participants | 1 Participants |
| Highest Level of Education Associate degree / some college | 1 Participants | 8 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Highest Level of Education Bachelor's degree | 3 Participants | 41 Participants | 8 Participants | 11 Participants | 1 Participants | 2 Participants | 3 Participants | 11 Participants | 2 Participants |
| Highest Level of Education High school graduate / GED | 0 Participants | 11 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants |
| Highest Level of Education Refuse to answer | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Highest Level of Education Vocational / Technical training | 0 Participants | 4 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Marital Status Divorced/Separated | 0 Participants | 6 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Marital Status I don't know/refused | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Marital Status Married | 5 Participants | 104 Participants | 20 Participants | 26 Participants | 6 Participants | 5 Participants | 16 Participants | 22 Participants | 4 Participants |
| Marital Status Partnered | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Marital Status Single, never married | 0 Participants | 5 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
| Marital Status Widowed | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 5 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized I don't know/refuse to answer | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 4 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 103 Participants | 20 Participants | 26 Participants | 6 Participants | 6 Participants | 14 Participants | 24 Participants | 3 Participants |
| Sex: Female, Male Female | 5 Participants | 86 Participants | 7 Participants | 31 Participants | 1 Participants | 6 Participants | 10 Participants | 25 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 35 Participants | 15 Participants | 1 Participants | 5 Participants | 0 Participants | 7 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 6 | 0 / 6 | 0 / 5 | 0 / 4 | 5 / 29 | 0 / 17 | 3 / 32 | 0 / 22 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 4 | 0 / 29 | 0 / 17 | 0 / 32 | 0 / 22 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 4 | 0 / 29 | 0 / 17 | 0 / 32 | 0 / 22 |
Outcome results
Primary
Feasibility of the BOLSTER Intervention
≥50% consent-to-approach ratio
Time frame: 1 month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Approached | Feasibility of the BOLSTER Intervention | Consented | 73 Participants |
| Patients Approached | Feasibility of the BOLSTER Intervention | Did not consent | 22 Participants |
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.
Time frame: 3 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Patients Approached | Acceptability of the BOLSTER Intervention | Acceptability - I have been satisfied with the BOLSTER program sessions... | Strongly agree | 14 Participants |
| Patients Approached | Acceptability of the BOLSTER Intervention | Acceptability - I have been satisfied with the BOLSTER program sessions... | Agree | 6 Participants |
| Patients Approached | Acceptability of the BOLSTER Intervention | Acceptability - I have been satisfied with the BOLSTER program sessions... | Neither agree nor disagree | 2 Participants |
| Patients Approached | Acceptability of the BOLSTER Intervention | Acceptability - I would recommend the BOLSTER program to other patients... | Strongly agree | 16 Participants |
| Patients Approached | Acceptability of the BOLSTER Intervention | Acceptability - I would recommend the BOLSTER program to other patients... | Agree | 5 Participants |
| Patients Approached | Acceptability of the BOLSTER Intervention | Acceptability - I would recommend the BOLSTER program to other patients... | Neither agree nor disagree | 1 Participants |
| Phase II (RCT): BOLSTER Arm Caregivers | Acceptability of the BOLSTER Intervention | Acceptability - I would recommend the BOLSTER program to other patients... | Agree | 2 Participants |
| Phase II (RCT): BOLSTER Arm Caregivers | Acceptability of the BOLSTER Intervention | Acceptability - I have been satisfied with the BOLSTER program sessions... | Strongly agree | 8 Participants |
| Phase II (RCT): BOLSTER Arm Caregivers | Acceptability of the BOLSTER Intervention | Acceptability - I would recommend the BOLSTER program to other patients... | Strongly agree | 8 Participants |
| Phase II (RCT): BOLSTER Arm Caregivers | Acceptability of the BOLSTER Intervention | Acceptability - I have been satisfied with the BOLSTER program sessions... | Agree | 2 Participants |
| Phase II (RCT): BOLSTER Arm Caregivers | Acceptability of the BOLSTER Intervention | Acceptability - I would recommend the BOLSTER program to other patients... | Neither agree nor disagree | 0 Participants |
| Phase II (RCT): BOLSTER Arm Caregivers | Acceptability of the BOLSTER Intervention | Acceptability - I have been satisfied with the BOLSTER program sessions... | Neither agree nor disagree | 0 Participants |