Clinical trial NCT03367247: BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal
Official title: BOLSTER: Building Out Lifelines for Safety, Trust, Empowerment and Renewal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Gastrointestinal Cancer
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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-12-08
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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 exclusion criteria:

* Unable to read and respond to questions in English,
* Cognitive impairment
* Unable to complete the baseline interview

Primary outcomes:
measure: Feasibility of the BOLSTER Intervention
timeFrame: 1 month
Secondary outcomes:
measure: Acceptability of the BOLSTER Intervention
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: 25873
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Alexi A Wright, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.