RECRUITING

Patient-Centered Surgical Prehabilitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to validate the prehabilitation program which is defined as a set of interventions meant to prepare the body physically and nutritionally for the cystectomy procedure.

Official Title

Patient-Centered Surgical Prehabilitation

Quick Facts

Study Start:2023-03-01

Study Completion:2027-12-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05715684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patents must be candidates for all types of cystectomy surgery including urinary diversion via open or robotic approach. 2. Patients between the ages 18 and 85 years 3. American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4 4. Ileal conduit or ileal neobladder urinary diversion 5. Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent	1. Scheduled for a partial cystectomy 2. Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy 3. More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery 4. The presence of metastatic cancer 5. Be undergoing treatment for another type of cancer concurrently 6. Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed. 7. Pregnant (identified by a positive serum pregnancy test administered after the initial screening process and before the commencement of study activities) or lactating, or not postmenopausal (no menses for at least 1 year) and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam; or abstinence) (Participants will be asked to use birth control for the entire study and for at least 2 weeks after the last dose of study drug.) 8. Participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study 9. Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery 10. Using illicit drugs or abusing alcohol 11. History of previous surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might have confounded the study results or might have posed additional risk in administering the study procedures 12. Patients with severe dementia (as determined from medical records and history. Severe dementia will be defined as dementia that impacts daily functioning.) 13. Patients with severe hepatic impairment as defined by Child-Pugh Class C. Patients with Child-Pugh Class A-B hepatic impairment are eligible for the study. 14. A history of heart failure. 15. Patients with end-stage renal disease as defined by GFR \<15. 16. Patients with heart failure. 17. Patients with complete gastrointestinal obstruction. 18. Patients with gastrostomy tube, jejunostomy tube or who require enteral tube feeds. 19. Non-English-speaking patients

Inclusion Criteria

Exclusion Criteria

1. Patents must be candidates for all types of cystectomy surgery including urinary diversion via open or robotic approach.
2. Patients between the ages 18 and 85 years
3. American Society of Anesthesiologists (ASA) Physical Status Score of class 1-4
4. Ileal conduit or ileal neobladder urinary diversion
5. Able to understand the study procedures, agreed to participate in the study program, and voluntarily provided informed consent

1. Scheduled for a partial cystectomy
2. Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
3. More than three doses of opioids (oral or parenteral) within 7 days before the day of surgery
4. The presence of metastatic cancer
5. Be undergoing treatment for another type of cancer concurrently
6. Chemotherapy for bladder cancer within 1 month of scheduled surgery; prior neoadjuvant chemotherapy allowed.
7. Pregnant (identified by a positive serum pregnancy test administered after the initial screening process and before the commencement of study activities) or lactating, or not postmenopausal (no menses for at least 1 year) and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam; or abstinence) (Participants will be asked to use birth control for the entire study and for at least 2 weeks after the last dose of study drug.)
8. Participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study
9. Clinically significant laboratory abnormalities at screening that would have resulted in the cancellation of surgery
10. Using illicit drugs or abusing alcohol
11. History of previous surgeries, illness, or behavior (eg, depression, psychosis) that in the opinion of the investigator might have confounded the study results or might have posed additional risk in administering the study procedures
12. Patients with severe dementia (as determined from medical records and history. Severe dementia will be defined as dementia that impacts daily functioning.)
13. Patients with severe hepatic impairment as defined by Child-Pugh Class C. Patients with Child-Pugh Class A-B hepatic impairment are eligible for the study.
14. A history of heart failure.
15. Patients with end-stage renal disease as defined by GFR \<15.
16. Patients with heart failure.
17. Patients with complete gastrointestinal obstruction.
18. Patients with gastrostomy tube, jejunostomy tube or who require enteral tube feeds.
19. Non-English-speaking patients

Contacts and Locations

Study Contact

Matthew Mossanen, MD, MPH

CONTACT

617-732-6384

mmossanen@bwh.harvard.edu

Nnamdi Onochie

CONTACT

6175258753

nnamdi_onochie@dfci.harvard.edu

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01

Study Completion Date2027-12-25

Study Record Updates

Study Start Date2023-03-01

Study Completion Date2027-12-25

Terms related to this study

Additional Relevant MeSH Terms

Bladder Cancer
Cystectomy