Behavioral Intervention for Reducing Sedentary Lifestyle in Prostate Cancer Survivors

Overseen By Linda Trinh, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Other cancer, Walking issues, Falls, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since medical clearance from a primary health care provider is required, it's best to discuss your medications with them.

What data supports the effectiveness of the treatment for reducing sedentary lifestyle in prostate cancer survivors?

Research shows that using tools like Fitbits and web-based interventions can help prostate cancer survivors reduce their sedentary behavior and improve their quality of life. These interventions are designed to encourage more physical activity and less sitting time, which can lead to better health outcomes. ^{1 2 3 4 5}

Is the behavioral intervention for reducing sedentary lifestyle in prostate cancer survivors safe?

The research does not provide specific safety data for the behavioral intervention, but similar interventions like mindfulness meditation training have been found feasible and acceptable, suggesting they are generally safe for prostate cancer survivors. ^{1 3 6 7 8}

How is the Digital Meditation Intervention treatment different from other treatments for reducing sedentary lifestyle in prostate cancer survivors?

The Digital Meditation Intervention is unique because it uses a remote app to deliver mindfulness meditation training, which can be more accessible and convenient for prostate cancer survivors who may face barriers to attending in-person programs. This approach focuses on reducing sedentary behavior through mindfulness, which is different from traditional physical activity interventions. ^{1 2 3 9 10}

Research Team

Linda Trinh, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

This trial is for prostate cancer survivors in Canada who are mostly inactive, sitting for over 8 hours a day, and not currently undergoing radiation or chemotherapy. They should be ready to start becoming more active, have no severe heart issues or walking disabilities, and must not have had a serious fall recently.

Inclusion Criteria

Currently residing in Canada

You spend more than 8 hours a day sitting or being inactive.

I am not currently receiving radiation or chemotherapy.

Exclusion Criteria

Not planning to live in Canada for the next 12 months

I use a device to help me walk.

I cannot walk due to a severe condition like bad knee or hip arthritis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week behavioural intervention including a FitBit and 6 behavioural support sessions with a movement specialist

12 weeks

6 remote sessions (4 one-on-one, 2 group webinars)

Follow-up

Participants are monitored for changes in sedentary behaviour and physical activity at 6-months post-intervention

6 months

Treatment Details

Interventions

• FitBit Only
• Intervention

Trial Overview The study tests if a 12-week program with a FitBit and behavioral support sessions can reduce sedentary behavior in prostate cancer survivors compared to those just given a FitBit. It also looks at the program's impact on physical activity levels, motivation, sleep quality, social support, physical function, life quality, fatigue disability and mental health.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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.

Group II: Fitbit Only Active Control 1 Intervention

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

Intervention is already approved in United States for the following indications:

Approved in United States as Digital Meditation Intervention for:

• Loneliness in Older Adults
• Social Isolation
• Emotional Well-being

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

The web-based intervention RiseTx successfully reduced sedentary time by an average of 455.4 weekly minutes and increased moderate-to-vigorous physical activity by 44.1 weekly minutes among 46 prostate cancer survivors over a 12-week period.

Participants reported high satisfaction with the intervention, indicating its feasibility; however, additional strategies may be necessary to maintain these behavior changes in the long term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RiseTx: testing the feasibility of a web application for reducing sedentary behavior among prostate cancer survivors receiving androgen deprivation therapy. Trinh, L., Arbour-Nicitopoulos, KP., Sabiston, CM., et al.[2018]

The OncoActive intervention, which provided personalized physical activity feedback to prostate and colorectal cancer survivors, did not show significant long-term differences in physical activity levels compared to a control group at the 12-month follow-up, although self-reported days of physical activity were higher in the OncoActive group.

Participants in the OncoActive group experienced significantly lower fatigue levels compared to the control group at 12 months, suggesting that the intervention may help improve certain health-related outcomes even if physical activity levels did not differ significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy of a computer-tailored physical activity intervention for prostate and colorectal cancer patients and survivors: A randomized controlled trial. Golsteijn, RHJ., Bolman, C., Peels, DA., et al.[2023]

This study aims to evaluate a 12-week intervention combining Fitbit use and behavioral counseling to reduce sedentary behavior and increase light-intensity physical activity among prostate cancer survivors, with 120 participants recruited across Canada.

The intervention is designed to help participants gradually increase their daily step counts by 3,000 steps above their baseline, potentially improving their quality of life and health outcomes by addressing the long-term side effects of prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A distance-based, randomized controlled trial for reducing sedentary behavior among prostate cancer survivors: a study protocol. Trinh, L., Sabiston, CM., Alibhai, SMH., et al.[2022]

The ENGAGE study, involving 147 prostate cancer survivors, demonstrated that an exercise intervention significantly increased participants' task self-efficacy, meaning they felt more confident in their ability to engage in vigorous physical activity (VPA) after the program.

Task self-efficacy was found to partially mediate the positive effects of the exercise intervention on VPA, indicating that improving confidence in exercise capability is crucial for enhancing physical activity levels in prostate cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of Physical Activity Behavior Change for Prostate Cancer Survivors: A Cluster Randomized Controlled Trial. Craike, MJ., Gaskin, CJ., Mohebbi, M., et al.[2020]

Only a small percentage of long-term prostate cancer survivors (11.8% using diet and 7.8% using exercise) actively employed dietary changes or exercise to manage their condition, indicating a potential gap in awareness or utilization of these strategies.

Younger, more educated survivors, and those involved in support groups were more likely to adopt these lifestyle changes, suggesting that targeted counseling could enhance the use of diet and exercise to improve quality of life and cancer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. Hughes, S., Egger, S., Carle, C., et al.[2020]

In a study involving 90 prostate cancer patients undergoing radiotherapy, those practicing qigong/tai chi reported longer sleep duration midway through treatment compared to those in light exercise or waiting list control groups, although this improvement did not last over time.

No significant differences were found in other sleep or fatigue measures between the groups, suggesting that while qigong/tai chi may offer some short-term benefits for sleep, it does not significantly impact overall fatigue or other sleep domains during radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qigong/tai chi for sleep and fatigue in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. McQuade, JL., Prinsloo, S., Chang, DZ., et al.[2022]

The Community of Wellness is a Web-based intervention designed to support prostate cancer survivors in improving their physical activity and dietary habits, with a randomized controlled trial currently enrolling 200 participants to assess its feasibility and acceptability.

Preliminary results will help determine the most effective level of online support needed to promote health behavior changes in men with prostate cancer, potentially informing future scalable health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial. Winters-Stone, KM., Kenfield, SA., Van Blarigan, EL., et al.[2020]

In an 8-week pilot study involving 43 men on active surveillance for prostate cancer, mindfulness training significantly reduced anxiety and uncertainty while enhancing mental health and posttraumatic growth compared to a control group.

The mindfulness program was found to be feasible and acceptable, although the enrollment response rate was lower than expected, indicating the need for larger studies to further assess its efficacy in helping men manage stress related to their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial. Victorson, D., Hankin, V., Burns, J., et al.[2018]

In a study of 98 prostate cancer survivors, increases in moderate-to-vigorous physical activity (MVPA) of 15 to 33 minutes per day were linked to clinically important improvements in quality of life, particularly in areas like insomnia and financial difficulties.

Decreases in sedentary behavior by 119 to 107 minutes per day were also associated with clinically important improvements in physical and role functioning, highlighting the potential benefits of reducing inactivity for prostate cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of objectively measured moderate-to-vigorous physical activity and sedentary behavior with quality of life and psychological well-being in prostate cancer survivors. Gaskin, CJ., Craike, M., Mohebbi, M., et al.[2018]

A review of 12 studies involving prostate cancer survivors suggests that physical activity behavior change interventions can improve quality of life, particularly through aerobic activities immediately after the intervention.

While many studies showed positive results, the variability in study designs and lack of specific data for prostate cancer limit the ability to draw definitive conclusions about the most effective intervention characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of physical activity-based behaviour change interventions reaching men with prostate cancer. Finlay, A., Wittert, G., Short, CE.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

RiseTx: testing the feasibility of a web application for reducing sedentary behavior among prostate cancer survivors receiving androgen deprivation therapy. [2018]

2. China pubmed.ncbi.nlm.nih.gov

Long-term efficacy of a computer-tailored physical activity intervention for prostate and colorectal cancer patients and survivors: A randomized controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A distance-based, randomized controlled trial for reducing sedentary behavior among prostate cancer survivors: a study protocol. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Mechanisms of Physical Activity Behavior Change for Prostate Cancer Survivors: A Cluster Randomized Controlled Trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Factors associated with the use of diet and the use of exercise for prostate cancer by long-term survivors. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Qigong/tai chi for sleep and fatigue in prostate cancer patients undergoing radiotherapy: a randomized controlled trial. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Associations of objectively measured moderate-to-vigorous physical activity and sedentary behavior with quality of life and psychological well-being in prostate cancer survivors. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

A systematic review of physical activity-based behaviour change interventions reaching men with prostate cancer. [2022]