Participating in Tai Chi to Reduce Anxiety and Keep up Physical Function (PEAK-RP)
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|ClinicalTrials.gov Identifier: NCT05452824|
Recruitment Status : Recruiting
First Posted : July 11, 2022
Last Update Posted : July 11, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Tai Chi Prehabilitation Other: Usual care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-centered, single-blind, parallel design randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Participating in Tai Chi to Reduce Anxiety and Keep up Physical Function: Implementing a Prehabilitation Intervention for Radical Prostatectomy|
|Actual Study Start Date :||June 21, 2021|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||October 2023|
Experimental: Tai Chi Prehabilitation
8 weeks Tai Chi prehabilitation prior to radical prostatectomy
Other: Tai Chi Prehabilitation
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.
Placebo Comparator: Usual Care
Other: Usual care
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.
- Participant recruitment rate [ Time Frame: 8 weeks ]Evaluate the percentage of patients willing to participate in the intervention among eligible patients approached
- Intervention uptake ratio [ Time Frame: 8 weeks ]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.
- Adherence to intervention [ Time Frame: 8 weeks ]Calculate percentage of intervention completions based on the numbers of attended sessions and the duration of attendance
- Reasons for withdrawal [ Time Frame: 8 weeks ]Will record reasons for withdrawal for those participants that withdraw from the study, when applicable.
- Adverse events [ Time Frame: 8 weeks ]Will record all adverse events that occur over the course of the intervention, if applicable.
- Intervention barriers and facilitators [ Time Frame: 8 weeks ]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)
- Pittsburgh Sleep Quality Inventory (PSQI) [ Time Frame: 5 months ]Measure of sleep quality captured by a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items (scored on scale from 0-3) generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score (range: 0-21) where a higher score corresponds to lower sleep quality.
- Short Form-36 (SF-36) [ Time Frame: 5 months ]Measure quality of life assessed SF-36 measures eight scales including 36 items on: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH); Overall score between 0-100, where lower scores correspond to greater disability.
- General Anxiety Disorder 7-item Scale (GAD-7) [ Time Frame: 5 months ]7-item anxiety scale where responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0-3. Items are summed to provide a total score ranging from 0-21, where a higher score corresponds to greater anxiety.
- Patient Health Questionnaire (PHQ-9) [ Time Frame: 5 months ]the PHQ-9 is the depression module of the Patient Health Questionnaire (PHQ), which is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 module scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day) for a total score ranging from 0-27, where higher scores correspond to greater levels of depression.
- Brief Pain Inventory (BPI) [ Time Frame: 5 months ]Measure of pain he BPI is an 11-item questionnaire that consists of four 0-to-10 numeric rating scale (NRS) items asking patients to rate their pain at its "worst in the last 24-hours," "least in the last 24-hours," "average," and "now," with a 0 indicating "no pain" and 10 representing "pain as bad as you could imagine." The remaining seven BPI items probe the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life, again using a 0-to-10 NRS. For these interference items, 0 represents "does not interfere" and 10 indicates "interferes completely." The arithmetic mean of the 4 pain severity items is taken as a measure of pain severity, and the seven interference items can be used as a measure of pain interference (higher score = higher pain severity/pain interference)
- Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: 5 months ]Expanded Prostate Cancer Index Composite for Clinical Practice is a 1-page, 16-item questionnaire that we constructed to measure urinary incontinence, urinary irritation, and the bowel, sexual and hormonal health related quality of life domains. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better Health-Related Quality of Life (HRQOL).
- Physical function [ Time Frame: 5 months ]Physical function will be assessed through handgrip strength measured by a dynamometer, six minute walk test measured with a stopwatch and measuring tape, and four functional tests in accordance with the US CDC STEADI (Stopping Elderly Accidents, Deaths & Injuries) older adults fall prevention program that consists of 30-seconds chair stand test, 4-stage balance test, timed up and go test, and orthostatic blood pressure. These measures are standardized and validated gait, strength and balance assessment and predictors of physical function.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05452824
|Contact: Lin Yang, PhDemail@example.com|
|Contact: Nicole Slotfirstname.lastname@example.org|
|Prostate Cancer Centre||Recruiting|
|Calgary, Alberta, Canada, T2V1P9|
|Contact: Candace Frey 4039438954 email@example.com|
|Principal Investigator:||Lin Yang, PhD||Alberta Health services|
|Responsible Party:||Lin Yang, Research Scientist, AHS Cancer Control Alberta|
|Other Study ID Numbers:||
|First Posted:||July 11, 2022 Key Record Dates|
|Last Update Posted:||July 11, 2022|
|Last Verified:||July 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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