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NCT Number: NCT05790850

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

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.

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Key information

Conditions

Bladder Cancer Behavior Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Motor Activity Muscle-Invasive Bladder Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Non-muscle-invasive Bladder Cancer Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location status: Recruiting

Location contact

Ashley Byrne

CONTACT

[email protected]

Christine Ibilibor

CONTACT

[email protected]

Christine Ibilibor, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-operative physical exercise

Behavioral

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

Behavioral

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 outcomes

  1. Number of patient-reported days devoted to solitary psychological support

    Time frame: 30 days

    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

  2. Number of patient-reported days devoted to exercise

    Time frame: 30 days

    Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group

Secondary outcomes

  1. Post-operative complication rate

    Time frame: 30 days post-operatively

    Percentage of patients with a Clavien Grade 3 or higher complications at 30-days post-operatively

  2. Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.

    Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively

    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.

  3. Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)

    Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively

    Maximal oxygen uptake will be measured using a cycle ergometer-based cardiopulmonary exercise testing (CPET).

  4. Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)

    Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively

    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.

  5. Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10)

    Time frame: 4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Ibilibor

CONTACT

[email protected]

4349240871

Francesca Whitefield

CONTACT

[email protected]

4349240871

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • American Cancer Society, Inc.
  • Integrated Translational Health Research Institute of Virginia (iTHRIV)

Registry information

Acronym: PRIMER

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 30, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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