Participating in Tai Chi to Reduce Anxiety and Keep up Physical Function

NCT05452824 | Unknown

• 1 other identifier: 200345
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed project is to test the implementation strategy, in terms of feasibility and utility, of an online Tai Chi intervention as a prehabilitation model to prepare prostate cancer patients and their caregivers for radical prostatectomy (RP). The investigators' hypothesis is that, by using an online teaching module, the proposed prehabilitation model is feasible on the prostate cancer care pathway in a simple, efficient, and minimally disruptive manner. In addition, participating in the Tai Chi intervention will improve patient anxiety leading up to the RP and improve physical function as well as post-operative side-effects associated with RP. Our primary objective is to test the feasibility of the implementation strategy from multi-stakeholder perspectives. The investigators will use mixed-methods to assess the barriers and facilitators related to implementing the online Tai Chi intervention from multi-stakeholder perspectives guided by the Consolidated Framework for Implementation Research. Our secondary objective is to examine the effect of the Tai Chi intervention on patient outcomes at peri-RP and post-RP. The investigators will quantitatively test the effect of the intervention to reduce peri- and post-RP anxiety and improve peri- and post-RP physical function and general disease specific patient-reported outcomes. An exploratory objective is to explore the effect of the Tai Chi intervention on surgical outcomes. The study team will quantitatively describe the difference in post-RP surgical outcomes between the intervention and control groups.

Conditions

Prostate Cancer

Keywords

Radical Prostatectomy

Outcome Measures

Primary Outcomes (6)

• Participant recruitment rate

  Evaluate the percentage of patients willing to participate in the intervention among eligible patients approached

  8 weeks

• Intervention uptake ratio

  A ratio of the number of participants who actively participated in the intervention against the total number of participants in the intervention group will be assessed.

  8 weeks

• Adherence to intervention

  Calculate percentage of intervention completions based on the numbers of attended sessions and the duration of attendance

  8 weeks

• Reasons for withdrawal

  Will record reasons for withdrawal for those participants that withdraw from the study, when applicable.

  8 weeks

• Adverse events

  Will record all adverse events that occur over the course of the intervention, if applicable.

  8 weeks

• Intervention barriers and facilitators

  Qualitative data collection and interview guide development will follow the CFIR methodology to assess the intervention barriers and facilitators under five domains: intervention characteristics (key attributes of interventions), outer setting (factors outside the implementation organization), inner setting (factors within the implementation organization), characteristics of the individuals involved (perceptions, attitudes, and motivation of individuals), and the process (strategies to support implementation)

  8 weeks

Secondary Outcomes (7)

• Pittsburgh Sleep Quality Inventory (PSQI)

  5 months

• Short Form-36 (SF-36)

  5 months

• General Anxiety Disorder 7-item Scale (GAD-7)

  5 months

• Patient Health Questionnaire (PHQ-9)

  5 months

• Brief Pain Inventory (BPI)

  5 months

Study Arms (2)

Tai Chi Prehabilitation

EXPERIMENTAL

8 weeks Tai Chi prehabilitation prior to radical prostatectomy

Other: Tai Chi Prehabilitation

Usual Care

PLACEBO COMPARATOR

Usual care

Other: Usual care

Interventions

Tai Chi Prehabilitation OTHER

The intervention arm will be oriented to a WaQi (youthful vitality) program 8 weeks prior to their scheduled surgery date. The WaQi program uses a Tai Chi curriculum previously successfully implemented in older adults, and at the Memorial Sloan Kettering Cancer Center (MSKCC). It has an online teaching module and is uniquely suited for our study population. The program requires no difficult movement transitions, but still contains all essential parts including meditation. The WaQi program has less psychological stress and physical challenge than other exercise activities because it can be performed either sitting or standing. Intervention participants will also receive printed materials from Prostate Cancer Canada about prostate cancer management. These materials include information about how to cope with prostate cancer including pelvic floor exercise, physical activity, healthy eating, and mental wellbeing.

Tai Chi Prehabilitation

Usual care OTHER

Control arm participants will receive printed materials identical to intervention arm participants with general information on a healthy lifestyle. The control arm will receive an 8-week online Tai Chi teaching module subscription at the end of the study.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Must speak English.
• Scheduled and awaiting radical prostatectomy for prostate cancer
• Not previously treated for prostate cancer, including radiation therapy to the pelvis, major pelvic surgery, or placement of a penile implant or artificial urinary sphincter
• No known urethral stricture or colostomy or chronic urinary catheterization
• No medical or current psychiatric disorders that precludes their participation in the
• Permission to exercise from their primary physicians
• Not currently practicing Tai Chi or related activities that involve mindfulness practice
• Has access to a computer or tablet, reliable internet and the skills/knowledge to use email, complete online questionnaire and attend Zoom meetings.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

Prostate Cancer Centre

Calgary, Alberta, T2V1P9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Lin Yang, PhD

  Alberta Health services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Although it is not possible to blind participants or interventionists to group allocation, the random allocation sequence will be blinded from study staff conducting data management and analyses. The randomization schedule, generated by the project data analyst, will be kept by project staff who will deliver it, in a sealed envelope, to a research assistant who will then assign qualified individuals to intervention groups. Randomization will occur after informed consent is obtained and baseline assessments have been completed. Participants will be notified of their allocation through phone calls.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Single-centered, single-blind, parallel design randomized controlled trial

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 11, 2022
• Study Start: June 21, 2021
• Primary Completion: August 30, 2023
• Study Completion: October 1, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

CA (1)