search
Back to results

Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial) (PRIMER)

Primary Purpose

Bladder Cancer, Non-muscle-invasive Bladder Cancer, Muscle-Invasive Bladder Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-operative physical exercise
Pre-operative mindfulness meditation practice
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer focused on measuring Mindfulness, Meditation, Physical Exercise, Pre-habilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged ≥18 years of age Good surgical candidate determined by treating surgeon Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology Adequate Organ Function per protocol definition ECOG performance status ≤2 Received medical clearance to complete cardiopulmonary exercise testing Willing to use the personal or study provided devices for monitoring and performing the exercise routines. Fluent in English or Spanish for the EORTC QLQ questionnaire No known contraindications to high intensity exercise Exclusion Criteria: Contraindications to participating in aerobic exercise Currently participating in an aerobic exercise program New onset chest pain nor dyspnea with exertion Histologically documented micropapillary or sarcomatoid bladder cancer Distant metastatic carcinoma

Sites / Locations

  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Usual preoperative care prior to radical cystectomy

Preoperative pre-habilitation

Outcomes

Primary Outcome Measures

Number of patient-reported days devoted to solitary psychological support
Patient-reported days devoted to self-directed solitary psychological support related to cancer treatment during a 30 day period pre-operatively in the pre-habilitation program group
Number of patient-reported days devoted to exercise
Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group

Secondary Outcome Measures

Post-operative complication rate
Percentage of patients with a Clavien Grade 3 or higher complications at 30-days post-operatively
Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.
The EORTC QLQ BLM 30 consists of 30 questions developed to assess the quality of life of cancer patients. It incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. The questionnaire was designed to be cancer-specific, multidimensional in structure, appropriate for self-administration, and applicable across a range of cultural settings. All of the scales and single-item measures range in score from 0 to 100. A higher score represents higher symptomatology in each respective domain.
Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)
Maximal oxygen uptake will be measured using a cycle ergometer-based cardiopulmonary exercise testing (CPET).
Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)
The Mindfulness Awareness Attention Scale (MAAS) is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Total scores range from 0 to 6; higher scores indicate higher dispositional mindfulness.
Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10)
the Perceived Stress Scale 10 (PSS 10) is a 10-item survey that captures the respondent's stress level in the past month and uses a Likert scale to assess different domains of stress. Individual scores on the PSS 10 can range from 0 to 40 with higher scores indicating higher perceived stress.

Full Information

First Posted
March 16, 2023
Last Updated
May 9, 2023
Sponsor
University of Virginia
Collaborators
American Cancer Society, Inc., Integrated Translational Health Research Institute of Virginia (iTHRIV)
search

1. Study Identification

Unique Protocol Identification Number
NCT05790850
Brief Title
Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Acronym
PRIMER
Official Title
Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
American Cancer Society, Inc., Integrated Translational Health Research Institute of Virginia (iTHRIV)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Non-muscle-invasive Bladder Cancer, Muscle-Invasive Bladder Carcinoma
Keywords
Mindfulness, Meditation, Physical Exercise, Pre-habilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual preoperative care prior to radical cystectomy
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Preoperative pre-habilitation
Intervention Type
Behavioral
Intervention Name(s)
Pre-operative physical exercise
Intervention Description
Virtual instructor-guided twice weekly cycling-based high-intensity aerobic exercise program for a total of 30 days. Participants will use a study provided recumbent exercise bike and wristband fitness tracker to exercise and log the number of days they exercise with an instructor and self-directed cycling.
Intervention Type
Behavioral
Intervention Name(s)
Pre-operative mindfulness meditation practice
Intervention Description
Daily self-directed mindfulness practice involving a guided imagery meditation for a total of 30 days. Participants will use a study provided guided-imagery meditation audio file loaded to a study provided wristband fitness tracker. Participants will log the number of days they listen to the audio file or participate in self-directed solitary psychological support.
Primary Outcome Measure Information:
Title
Number of patient-reported days devoted to solitary psychological support
Description
Patient-reported days devoted to self-directed solitary psychological support related to cancer treatment during a 30 day period pre-operatively in the pre-habilitation program group
Time Frame
30 days
Title
Number of patient-reported days devoted to exercise
Description
Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Post-operative complication rate
Description
Percentage of patients with a Clavien Grade 3 or higher complications at 30-days post-operatively
Time Frame
30 days post-operatively
Title
Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.
Description
The EORTC QLQ BLM 30 consists of 30 questions developed to assess the quality of life of cancer patients. It incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease. The questionnaire was designed to be cancer-specific, multidimensional in structure, appropriate for self-administration, and applicable across a range of cultural settings. All of the scales and single-item measures range in score from 0 to 100. A higher score represents higher symptomatology in each respective domain.
Time Frame
4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Title
Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)
Description
Maximal oxygen uptake will be measured using a cycle ergometer-based cardiopulmonary exercise testing (CPET).
Time Frame
4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Title
Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)
Description
The Mindfulness Awareness Attention Scale (MAAS) is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. Total scores range from 0 to 6; higher scores indicate higher dispositional mindfulness.
Time Frame
4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Title
Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10)
Description
the Perceived Stress Scale 10 (PSS 10) is a 10-item survey that captures the respondent's stress level in the past month and uses a Likert scale to assess different domains of stress. Individual scores on the PSS 10 can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged ≥18 years of age Good surgical candidate determined by treating surgeon Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology Adequate Organ Function per protocol definition ECOG performance status ≤2 Received medical clearance to complete cardiopulmonary exercise testing Willing to use the personal or study provided devices for monitoring and performing the exercise routines. Fluent in English or Spanish for the EORTC QLQ questionnaire No known contraindications to high intensity exercise Exclusion Criteria: Contraindications to participating in aerobic exercise Currently participating in an aerobic exercise program New onset chest pain nor dyspnea with exertion Histologically documented micropapillary or sarcomatoid bladder cancer Distant metastatic carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Ibilibor
Phone
4349240871
Email
ci5d@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Byrne
Phone
4349240871
Email
aeb6q@uvahealth.org
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Ibilibor
Email
CI5D@virginia.edu
First Name & Middle Initial & Last Name & Degree
Ashley Byrne
Email
aeb6q@uvahealth.org
First Name & Middle Initial & Last Name & Degree
Christine Ibilibor, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Summary of trial outcome data through publication or grant reporting requirements.

Learn more about this trial

Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)

We'll reach out to this number within 24 hrs