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

Bladder Cancer Clinical Trial

— PRIMER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790850
• Other study ID #: HSR210502
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: June 2025

Study information

• Verified date: May 2023
• Source: University of Virginia
• Contact: Christine Ibilibor
• Phone: 4349240871
• Email: ci5d[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Muscle-Invasive Bladder Carcinoma
• Non-muscle-invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Pre-operative physical exercise
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.
• Pre-operative mindfulness meditation practice
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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	American Cancer Society, Inc., Integrated Translational Health Research Institute of Virginia (iTHRIV)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Primary	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	30 days
Secondary	Post-operative complication rate	Percentage of patients with a Clavien Grade 3 or higher complications at 30-days post-operatively	30 days post-operatively
Secondary	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.	4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Secondary	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).	4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Secondary	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.	4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively
Secondary	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.	4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively