Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

Participants will be provided with a FitBit Inspire 2 and assigned a movement specialist. They will be asked to monitor their daily steps over the 12-week intervention period. Participants will attend 6 remotely-delivered behaviour change sessions (4 one-on-one sessions with their movement specialist, 2 group-based webinars). Sessions will be delivered bi-weekly and last \~30 minutes.

Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living (e.g., 24-hour movement guidelines).

During the first two weeks (baseline), participants will be asked to maintain their regular movement routine to set a baseline daily average step count. Phases I-III will involve self-regulatory strategies (e.g., action planning), address reducing/interrupting sedentary time, and step counts. Participants will be encouraged to increase their steps by 1000 steps/day from the baseline phase during each subsequent phase (i.e., 3000 steps above baseline by Phase III). Phases IV-V will be a maintenance phase through which participants will be encouraged to maintain 3000 steps per day above baseline. The sessions will be grounded within the Multi-Process Action Control Framework and address perceived capability/opportunity and instrumental/affective attitudes. The 1-on-1 sessions will focus on regulation (action \& coping planning, social support, goal setting) and reflexive processing (self-regulation, habit). The final one on one session will be a booster session to revisit previous topics.

Intervention

Participants will be provided with a FitBit Inspire 2 and access to publicly available resources about active living. They will receive a FitBit orientation session with a movement specialist prior to the 12-week control period.

FitBit Only

Linda Trinh, PhD

This randomized controlled trial (RCT) will aim to examine the effect of a 12-week behavioural intervention on changing the sedentary behaviours (SB) of prostate cancer survivors (PCS) compared to a control group (FitBit-only group). PCS in the intervention group will receive a FitBit and 6 behavioural support sessions with a movement specialist guided by behavioural theory (i.e., the Multi-Process Action Control \[M-PAC\]). The FitBit-only group will only receive a FitBit and access to public health resources on physical activity (PA). The primary purpose of this study is to determine the efficacy of the intervention on changing SB of PCS immediately following the 12-week intervention and 6-months later. It is hypothesized that that the intervention will decrease their SB compared to the FitBit-only control condition at both timepoints. This trial will also examine the effect of the intervention on changing PA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function, quality of life, fatigue, disability and mental health compared to the active control condition.

Many prostate cancer survivors (PCS) suffer from long-term side effects well beyond treatment, such as urinary incontinence, erectile dysfunction, fatigue, depression, and anxiety. Supportive care interventions are needed to reduce the chronic effects of cancer and its treatment during the transition into survivorship. Physical activity (PA) has a positive impact on many clinical outcomes, including improved quality of life (QoL), cancer-specific mortality, and reducing treatment-related toxicities among PCS. Despite this, few PCS achieve current PA guidelines and there is a significant decrease in PA during and following treatment. PCS spend most of their day sedentary (i.e., 69% of waking hours) or engaged in light-intensity PA (LPA; 30% of waking hours), therefore focusing on reducing sedentary behaviour (SB) among PCS may be a more feasible intervention approach than supervised exercise. SB is defined as any waking behaviour characterized by a low energy expenditure (i.e., ≤1.5 resting metabolic equivalents) while in a sitting, reclining, or lying down posture. Despite the growing evidence that reducing SB can result in better health outcomes for cancer survivors, there are no known effective strategies aimed at reducing SB and replacing it with PA among PCS.

It is important that behavioural interventions are informed by theory, as theory-driven approaches are crucial for facilitating the adoption and maintenance of behaviour change. The Multi-Process Action Control (M-PAC) framework, a theoretical framework developed from PA behaviour change research specifically, suggests a layered, progressive approach to behaviour change where an individual moves from intention formation to adoption of action control and onto maintenance of action control. Intention formation is predicated on initiating reflective processes (i.e., instrumental attitude and perceived capability). Reflective processes are hypothesized to influence intention formation and initiate regulatory processes to enact this intention (i.e., affective attitude and perceived opportunity). The translation of intention into PA (i.e., action control) is determined partially by regulatory processes (e.g., action planning, coping planning, self-monitoring, social support) during the initial adoption of the behaviour. Continuation of PA action control is thought to include the addition of reflexive processes (e.g., habit) for long-term PA maintenance. This is a useful approach for PA and SB behaviour change interventions as it highlights processes for several stages of change including adoption and maintenance.

Previously supervised interventions have demonstrated success in increasing PA behaviours among cancer survivors but, distance-based interventions make an attractive alternative as they have extended reach due to potentially easier access and lower cost. Wearable activity monitors (e.g., FitBit) have been a successful SB and PA self-management intervention tool for cancer survivors. A previous pilot study conducted by our research group examined the feasibility of an unguided mhealth application (RiseTx) for reducing SB and increasing MVPA among PCS undergoing androgen deprivation therapy (ADT). PCS were given an activity tracker, access to the RiseTx mhealth web application which deployed a range of behaviour change support tools to reduce SB, and a goal of increasing step counts by 3,000 daily steps above baseline levels over 12-weeks. The RiseTx mhealth application was successful in reducing device-measured SB by 455 minutes/week and increasing MVPA by 44 minutes/week, as well as increasing steps by 1535 between baseline and post-intervention. Building upon this successful pilot study, the current RCT will harness the many lessons learned during the implementation of the RiseTx mhealth application. As an extension of this prior work, this updated iSTRIDE intervention will provide additional synchronous behavioural support aligned with processes in the M-PAC framework through videoconferencing, to reduce SB.

The multi-site, two-arm RCT will test the efficacy of this updated intervention on changing SB and PA in PCS. The primary objective is to determine the effects of the 12-week intervention (i.e., FitBit + behavioural counselling) compared to a control condition (FitBit + public resources) in reducing sitting time in PCS. It is hypothesized that that the intervention group will decrease their SB compared to the FitBit-only control condition at post-intervention (12 weeks) and 6-month follow-up. Secondary objectives of this trial are to determine the effects of the intervention on secondary outcomes including changes in MVPA, LPA, motivational outcomes from the M-PAC framework, sleep quality, social support, physical function and patient reported outcomes (i.e., QoL, fatigue, disability and mental health) compared to the FitBit-only control condition.

Randomization will be performed using a stratified randomization scheme via REDCap. The sequence will be random permutated blocks of varying sizes, stratified by ADT use (ADT vs. no ADT). PCS will be assigned in a 1:1 ratio to one of two groups. Randomization codes will be kept in a pre-made digital file that is separate from other study records.

Due to the nature of the intervention, it is not possible to blind participants to their group allocation. Coordinating RAs will be the primary individuals responsible for scheduling all data collection assessments.

They will attempt to book all 3 assessments with same research assistant outcome assessor who meets the following criteria:

* Are not a movement specialist delivering one-on-one behavioural counselling
* Are not a movement specialist delivering a group webinar
* Are not aware of participant's group allocation

Any cases of unblinding will be noted in a Protocol Deviation Log.

A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

A Distance-based, Randomized Controlled Trial for Reducing Sedentary Behaviour Among Prostate Cancer Survivors

Perceived capability and opportunity will be assessed using a modified version of the Rhodes et al., (2006) measures of ability and opportunity. These constructs are measured through six statements (3 addressing ability and 3 addressing opportunity) regarding confidence and control over engaging in light physical activity to replace sedentary behaviour and scored using a 5-point likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Possible scores range from a 3-15 points with higher scores indicating more favorable perceptions of opportunity and ability.

Instrumental attitudes and affective judgements will be assessed using a modified version of the Rhodes and Courneya (2003) instrumental and affective attitude measure using a 7-point Likert scale (extremely disagree to extremely agree).

Regulatory processes will be measured through decisional intentions and behavioural regulation (i.e.,planning and monitoring). Decisional intentions will be measured using the following questions "I intend to engage in regular light physical activity _ times per week during the next 12 weeks", "I intend to break up my sitting time _ times per weekday during the next 12 weeks." and "I intend to break up my sitting time ________ times per weekend day during the next 12 weeks."

Behavioural regulation was measured using a modified version of the Sniehotta et al., (2005) planning questionnaire which assesses goal setting, action and coping planning, self-monitoring and scheduling on a 6-item scale. Each item is scored on a 5-point likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 6-30 points with higher scores indicating better self-regulation.

Reflexive processes will be measured through habit formation with the Self-Report Behavioural Automaticity Index from Gardner et al., (2012). Items are scored on a 5-point likert scale (1-strongly disagree to 5-strongly agree) summed to create a total score. Total scores can range from 4-20 points where higher scores indicate a behaviour is more habitual.

Disease-specific quality of life will be assessed with the reliable and well-validated Functional Assessment of Cancer Therapy (FACT)-General which consists of physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB), and social well-being (SWB) subscales. The FACT-Fatigue (FACT-Fatigue) scale includes the 27 items from the FACT-General scale plus the 13-item fatigue subscale. On all scales, higher scores indicate better QoL and less symptoms. Scores range from 0-108 and 0-156 for the FACT-General and FACT-Fatigue, respectively. Lower scores indicate a better quality of life.

General health-related quality of life will be measured using the Short Form-12 (SF-12). The SF-12 is a 12-item, shortened version of the SF-36 assessing physical functioning, bodily pain, role functioning, emotional well-being, social functioning, energy/fatigue, and health perceptions. It also includes a single item that provides an indication of perceived change in health. The SF-12 has good test-retest reliability correlations of 0.89 and 0.76 for the physical and mental component score, respectively. Additionally, scores from the SF-12 is highly correlated with scores from the complete SF-36 questionnaire. Higher scores indicate better quality of life. The SF-12 has been previously used in cancer populations.

Mental health, including anxiety and depression, will be assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item instrument comprised of an anxiety subscale score (HADS-A), a depression subscale score (HADS-D) and a total score (HADS-T), where higher scores indicate higher distress. Each item on the HADS is rated on a 4-point Likert scale, where 0 = 'not at all' and 3 = 'yes, definitely.'

Technology literacy (measured at baseline only) will be assessed using a modified version of the 8-item eHEALS ehealth literacy scale. The eHEALS measures combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems. It will be adapted to assess confidence in using and finding online information related to sedentary time and physical activity. Items will be rated using a 5-point Likert scale (strongly disagree-strongly agree). Scores range from 8-40 which higher scores representing greater self-perceived eHealth literacy.

10 researcher-generated questions will assess general patterns of internet and social media use, including methods used to access the internet and social media, frequency of use, devices owned and types of social media accounts owned, as well as use of internet and social media for information related to sedentary time and physical activity.

Disability will be assessed using the self-administered 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). This questionnaire is used to assess functioning in six major life domains (e.g., cognition, mobility, self-care, getting along, life activities, and participation). Simple scoring method will be used to sum the 12 items to create a Global Disability total score that will be used to describe the functional limitation of prostate cancer survivors. The scores for each item ranges from 1 (none) to 5 (extreme). Scores range from 1 to 60, higher scores represent greater disability.

A participant satisfaction survey will be administered post 12-week intervention to assess the acceptability of the intervention using research generated, closed response questions that ask: "Did the movement specialist effectively demonstrate constructive feedback throughout the Program"; "Was the workbook information and easy to follow?". The survey will assess the burden of the program and feedback about the manual, counselling sessions, and overall study experience. Likert scales ranging from 1 (not at all) to 7 (very much) will be used.

Lower body strength will be assessed with the 30-second sit to stand test. Participants will set up an armless chair against a wall or stable surface within view of the camera. Participants will start with their arms crossed over their chest, in the middle of the chair with their back straight, and feet flat on the floor. The participant will be instructed to stand fully then return to the start position as many times as they can in the 30-second assessment window. Study staff will oversee timing and counting the number of repetitions. Repetitions will only be scored if the participant touches the chair at the bottom of the movement and stand up completely straight at the top of the movement. Higher scores represent greater physical function.

Objectively-assessed sedentary behaviour will be assessed with activPAL inclinometers. The activPALs will be waterproofed and participants will be asked to wear the device in the mid-line of their right thigh for 7 days (24 hours per day). Participants will complete a wear log to identify sleep and non-wear periods. Total daily minutes of sedentary behaviour will be collected from the devices.

Self-reported sedentary behaviour will be assessed with the Longitudinal Aging Study Amsterdam (LASA) sedentary behaviour questionnaire. It assesses weekday and weekend sedentary time across 10 domains. The time (hours/minutes) in each domain is summed to determine a total amount of sedentary time.

Self-reported leisure time exercise will be assessed using the Godin Leisure Time Exercise Questionnaire. Participants will self-report the frequency and duration of light, moderate, and vigorous leisure-time exercise. This will be used to calculate a total leisure activity score (higher score indicates higher volumes of activity). The GLTEQ is a valid and reliable measure of exercise among oncology populations.

Objectively-assessed activity will be assessed with the activPALs. Minutes of activity at a cadence \>100 steps per minute will be considered moderate-to-vigorous physical activity.

Canadian Institutes of Health Research (CIHR)

University of Toronto

Assistant Professor

Behaviors and Mental Disorders

Quality of Life

Participants will use the Fitbit device and join the Facebook group. They will also receive brief weekly health coaching from a research staff. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide them with support.

Participants will be loaned a Fitbit device only. They will not join the Facebook group nor receive health coaching. They will not select an adult family member or friend to receive a Fitbit device to provide them with support.

Participants will use the FitBit device to track their physical activity (PA). Participants will receive and post messages and receive badges on the Facebook group. Weekly a research staff member will call them to provide brief health coaching. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide support.

Fitbit + Facebook + Coaching Group

Participants will receive a Fitbit device only, and will not receive health coaching, join the Facebook group, or select an adult family member or friend to receive a Fitbit to provide them with support.

Fitbit only

The Primary Goal is to conduct a 12 week pilot randomized controlled trial (RCT) of the Fitbit Flex, a popular, affordable, wearable physical activity tracking device, and the Fitbit mobile health (mHealth) app. The target population will be cancer survivors 18-39 years old recruited from the Seattle Cancer Care Alliance. For the intervention group, peer influences will be engaged via a private, social network (e.g. a Facebook group) customized for survivors. Measurements will be completed (1) at baseline, prior to randomization, and (2) during the final week of the intervention period (follow-up measure). This pilot study will provide initial proof of concept and allow for further customization of the intervention for cancer survivors in anticipation of a future, larger proposal to study physical activity and related outcomes over a multi-year period.

Besides conducting exploratory analyses of primary and secondary outcomes for this pilot RCT, we also specify feasibility criteria including: (1) recruiting 50 cancer survivors ages 18-39 years and between 1.0-5.0 years from the completion of active cancer therapy, (2) intervention participants wear the Fitbit Flex on the majority of all intervention days during the 12-week intervention period, and (3) ≥75% of all participants complete online questionnaire data collection at Time 1 and Time 2.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors	NCT05214937	Sedentary Behav... Cancer of Prost...	Intervention FitBit Only	18 Years -	University of Toronto
Improving Physical Activity in Young Adult Cancer Survivors	NCT03233581	Physical Activi... Quality of Life	Fitbit + Facebo... Fitbit only	18 Years - 39 Years	Seattle Children's Hospital
Improving Physical Activity in Young Adult Cancer Survivors	NCT03233581	Physical Activi... Quality of Life	Fitbit + Facebo... Fitbit only	18 Years - 39 Years	Seattle Children's Hospital

Spots Global Cancer Trial Database for fitbit only

Every month we try and update this database with for fitbit only cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fitbit only

Every month we try and update this database with for fitbit only cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fitbit only cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.