Clinical trial NCT05452824: Participating in Tai Chi to Reduce Anxiety and Keep up Physical Function
Official title: Participating in Tai Chi to Reduce Anxiety and Keep up Physical Function: Implementing a Prehabilitation Intervention for Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Radical Prostatectomy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2022-07-11
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-centered, single-blind, parallel design randomized controlled trial
Primary purpose: OTHER

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.

Detailed description: 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 primary objective is to test the feasibility of the implementation strategy from multi-stakeholder perspectives. The study team 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.

The investigators secondary objective is to examine the effect of the Tai Chi intervention on patient-reported outcomes at peri-RP and post-RP. The study team 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.

The tertiary objective is to explore the effect of the Tai Chi intervention on surgical outcomes. We will quantitatively test the effect of the intervention in improving post-RP surgical outcomes.

Study Design and Methods:

The study team will conduct a single-centered, single-blind, parallel design, randomized controlled trial with 40 participants randomly allocated to one of two arms: usual care or 8 weeks Tai Chi prior to RP with optional caregiver participation.

The study will use a staggered participant recruitment process, in which eligible participants will undergo initial screening, consent, and baseline assessments, and then be randomized based on a 1:1 ratio allocation schedule.

The study team will recruit 30 RP patients into each of the intervention and control arms of the study. The enrollment of a caregiver of the patient is optional.

Inclusion/exclusion criteria: All participants must speak English. RP patient participants include those: (1) scheduled and awaiting RP for prostate cancer; (2) 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; (3) with no known urethral stricture or colostomy or chronic urinary catheterization; (4) with no medical or current psychiatric disorders that preclude their participation in the intervention; (5) with permission to exercise from their primary physicians; and (6) not currently practicing Tai Chi or related activities that involve mindfulness practice. As an option, any support person identified by the patient as a primary caregiver who is \>18 years of age will be eligible. Finally, for qualitative assessment of the implementation, providers and support staff, and any individual who provides care/information for RP patients on a routine basis in a clinical setting will be eligible.

Potentially eligible patients who meet the initial inclusion criteria and individuals who are identified as the primary caregiver will be asked to participate in the study. Potential participants will be scheduled for a 1-hour virtual orientation meeting via password-protected Zoom and consent forms will be delivered to potential participants (patients and caregivers) via emails to obtain their electronic signature. At this meeting, the consent form, intervention activities and the participant responsibilities involved with the study will be discussed in depth. Participants who are clear about the study procedure and provide informed consent will be scheduled for a 1-hour in-office visit at the Prostate Cancer Center (PCC) for baseline evaluation. Prior to the in-office visit, COVID-19 screening will be performed, and symptomatic participants will be rescheduled.

Three days before participants come to the PCC, a Baseline Health Questionnaire (sociodemographic characteristics, lifestyle and gender role) and five questionnaires assessing study outcomes will be administered electronically for them to complete (Pittsburgh Sleep Quality Inventory, SF-36, Hospital Anxiety and Depression Scale, Brief Pain Inventory, the urinary and sexual domains of the Expanded Prostate Cancer Index Composite-50 \[spousal version for spousal caregivers\]. In addition, baseline frailty will be measured among patient participants through a modified frailty index using data extracted from electronic medical charts. One day prior to the visit, a COVID-19 screening questionnaire will be completed by telephone and if the participant is symptomatic, they will be rescheduled.

During the baseline evaluation at the PCC, hand hygiene, continuous masking and maintenance of physical distancing will be followed whenever possible. Data collection will include physical assessments of handgrip strength test and six minute walk test; and four functional tests in accordance with the US CDC STEADI program (30-second chair stand test, 4-stage balance test, timed up and go test, and orthostatic blood pressure) and instruction on how to wear an activity tracking device (Actigraph wGT3X-BT®) around their wrist for 7 days to measure usual physical activity levels. Participants will complete two self-administered questionnaires: Global Physical Activity Questionnaire assessing the physical activity in the past 7 days, and Sedentary Behavior Record assessing the daily patterns of activities exhibited in a sitting posture. To match the measurement phase between the device-based (Actigraph wGT3X-BT®) and self-reported assessments of physical activity and sedentary behavior, the Global physical Activity Questionnaire will be completed on the day that participants remove the Actigraph wGT3X-BT®, and the Sedentary Behavior Record will be completed on four consecutive days (two week and two weekend days) of participants' choice during the 7 days device wearing. -These questionnaires will be administered electronically after the baseline physical assessment, however, if the participant prefers a paper copy this option will be available at the baseline evaluation meeting. Consented participants who have completed baseline assessments will then be randomized.

Group 1: Tai Chi Intervention group (20 total participants) This group will be instructed to follow a Tai Chi program led by a certified teacher starting 8 weeks prior to their scheduled surgery date. To facilitate physical distancing in accordance to the current COVID-19 restrictions and while optimizing the quality of the intervention, the Tai Chi program will be administered virtually (via Zoom) by combining both supervised and unsupervised session. The program will be organized via a twofold approach: 1) a 60-minute supervised practice will be administered 2 days per week to patient participants and caregivers, if applicable. This session will be offered live via password protected Zoom and will be led by a Tai Chi instructor certified in WaQi teaching. It will include a warmup, agility training, meditation, slow movement, and meditation for cooling down; and 2) a 15-minute home-based program will be administered via an un-supervised online teaching module five days/week. It involves meditation, slow movement, and agility training and will be delivered via a webpage with a subscription for each patient participant and caregiver, if applicable.

Group 2: Usual activity group (20 total participants) This group will be instructed to maintain their physical activity levels for a total of 8 weeks. They will be provided with printed materials from Prostate Cancer Canada about prostate cancer management. They will receive an 8-week online Tai Chi teaching module subscription at the end of the study.

Participants in both control and intervention arms will wear the Actigraph wGT3X-BT® accelerometer for one week and complete two questionnaires (Global Physical Activity Questionnaire, and Sedentary Behavior Record) at 6 weeks after baseline (2 weeks prior to surgery). Participants will repeat five questionnaires (Pittsburgh Sleep Quality Inventory, SF-36, Hospital Anxiety and Depression Scales, Brief Pain Inventory, the urinary and sexual domains of the Expanded Prostate Cancer Index Composite-50 \[spousal version for spousal caregivers\]) and physical function tests at the 6 weeks after baseline (2 weeks prior to surgery), 6 weeks post-surgery (follow-up visit to review pathology and check PSA) and 12 weeks (or 3 months) post-surgery (PCC follow-up visit). Participants will complete additional Hospital Anxiety and Depression Scales at surgery day and at 2 weeks post-surgery (follow-up visit for catheter removal). Finally, frailty will be derived through a modified frailty index using data extracted from electronic medical charts at 12 weeks (or 3 months).

At the completion of the intervention/study 25 qualitative interviews will be conducted to assess the barriers and facilitators related to implementing the online Tai Chi intervention targeting five domains of the Consolidated Framework for Implementation Research (CFIR): intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Multiple stakeholders including 10 patient participants, 10 caregiver participants, the Tai Chi instructor and five healthcare providers will be interviewed to evaluate CFIR domains that are relevant to them. The interview will be semi-structured in design and will last approximately 1-hour via password-protected Zoom and recorded.

Eligibility criteria: Inclusion/Exclusion Criteria:

* 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.

Primary outcomes:
measure: Participant recruitment rate
timeFrame: 8 weeks
measure: Intervention uptake ratio
timeFrame: 8 weeks
measure: Adherence to intervention
timeFrame: 8 weeks
measure: Reasons for withdrawal
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
measure: Intervention barriers and facilitators
timeFrame: 8 weeks
Secondary outcomes:
measure: Pittsburgh Sleep Quality Inventory (PSQI)
timeFrame: 5 months
measure: Short Form-36 (SF-36)
timeFrame: 5 months
measure: General Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: 5 months
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 5 months
measure: Brief Pain Inventory (BPI)
timeFrame: 5 months
measure: Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: 5 months
measure: Physical function
timeFrame: 5 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Prostate Cancer Centre
state: Alberta
Study officials:
affiliation: Alberta Health services
name: Lin Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: