Prostate Cancer
Conditions
Keywords
exercise, World Trade Center Responders, Cancer Survivorship
Brief summary
People who responded to the World Trade Center (WTC) disaster on September 11, 2001 were exposed to toxic dust and smoke and have higher rates of certain health problems, including prostate cancer. Many WTC Responders with prostate cancer experience ongoing physical limitations, fatigue, and reduced quality of life, even after completing cancer treatment. Regular exercise can improve strength, balance, physical function, and well-being in people with cancer, but many men with prostate cancer do not meet recommended physical activity levels. Barriers such as travel, health concerns, and lack of access to tailored programs can make it difficult to participate in exercise programs. This pilot study will test whether a remotely delivered, supervised group exercise program is feasible and acceptable for WTC Responders with prostate cancer. The exercise program is delivered live by videoconference and is based on an established, evidence-based program for older adults. It includes aerobic, strength, balance, and flexibility exercises and is designed to be safe, supportive, and accessible to people living in different locations. A total of 40 WTC Responders with a history of prostate cancer will take part in this study. Participants will be randomly assigned to either (1) a 16-week remote exercise program or (2) a waitlist control group that receives usual care during the study period and is offered the exercise program after completing all study assessments. Participants in the exercise group will attend three one-hour exercise sessions per week using videoconferencing. The main goals of this study are to determine whether participants can be successfully recruited and retained, whether they attend and complete the exercise sessions, and whether they find the program acceptable and helpful. The study will also explore whether the exercise program improves physical function, physical activity, and quality of life. Physical function will be measured using simple movement tests performed remotely, and physical activity will be measured using a wearable activity monitor. Participants will also complete questionnaires about their health, physical functioning, and experiences with the program. In addition, this study will evaluate whether it is feasible for participants to collect saliva samples at home and return them by mail for future research. A subset of participants will be invited to complete interviews to share their experiences and provide feedback on how the program could be improved. Results from this pilot study will help inform the design of a larger future trial aimed at improving physical function and quality of life for WTC Responders with prostate cancer through accessible, remotely delivered exercise programs.
Interventions
BEHAVIORALRemote Supervised Exercise Program
Intervention Description \* § Definition: Details that can be made public about the intervention, other than the Intervention Name(s) and Other Intervention Name(s), sufficient to distinguish the intervention from other, similar interventions studied in the same or another clinical study. For example, interventions involving drugs may include dosage form, dosage, frequency, and duration. Limit: 1000 characters.
Sponsors
University of Vermont
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* World Trade Center (WTC) Health Program-certified diagnosis of prostate cancer * Completed initial treatment for prostate cancer (for example, surgery or radiation); participants may be on active surveillance or receiving androgen deprivation therapy * Low levels of regular physical activity (less than 90 minutes per week of moderate-to-vigorous activity and/or less than two strength-training sessions per week) * Able to understand and provide written informed consent (electronically or by mail) * Willing and able to participate in remotely delivered exercise sessions using videoconferencing
Exclusion criteria
* Metastatic cancer * Unable to ambulate independently, with or without an assistive device * Moderate or severe cognitive impairment * Unable to communicate in English * Unable or unwilling to attend scheduled exercise sessions (three times per week for 16 weeks) * Current participation in another structured exercise program or clinical trial that could confound study outcomes * Unstable or serious medical conditions that would pose a safety risk or limit compliance (for example, uncontrolled cardiovascular disease, severe psychiatric illness, or organ failure) Implanted cardioverter defibrillator (ICD) or recent lower extremity deep vein thrombosis \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Recruitment assessed from study start through completion of enrollment (up to 24 months) | Proportion of eligible participants who enroll in the study among those approached for participation. Unit of Measure: Percentage (%) |
| Retention Rate | From study start through completion of enrollment (up to 24 months) | Proportion of enrolled participants who complete the 16-week post-intervention assessment. Unit of Measure: Percentage (%) |
| Assessment Completion Rate | Baseline through 16-week post-intervention assessment | Proportion of participants completing baseline and post-intervention assessments (physical function testing and questionnaires). Unit of Measure: Percentage (%). |
| Intervention Adherence | Weeks 1-16 of the intervention period | Mean percentage of planned exercise sessions attended among participants randomized to the intervention arm (48 planned sessions over 16 weeks). Unit of Measure: Percentage (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue Measured by PROMIS-29 | Baseline and Week 16 | PROMIS-29 Fatigue T-score. Higher scores indicate worse fatigue. |
| Change in Sleep Disturbance Measured by PROMIS-29 | Baseline and Week 16 | PROMIS-29 Sleep Disturbance T-score. Higher scores indicate worse sleep disturbance. |
| Change in Pain Interference Measured by PROMIS-29 | Baseline and Week 16 | PROMIS-29 Pain Interference T-score. Higher scores indicate greater pain interference. |
| Change in Anxiety Measured by PROMIS-29 | Baseline and Week 16 | PROMIS-29 Anxiety T-score. Higher scores indicate worse anxiety. |
| Change in Average Daily Step Count Measured by activPAL Accelerometer | Baseline to 16 weeks | Average number of steps per day measured using a thigh-worn activPAL accelerometer worn continuously for 7 consecutive days. |
| Change in Depression Measured by PROMIS-29 | Baseline and Week 16 | PROMIS-29 Depression T-score. Higher scores indicate worse depressive symptoms. |
| Change in Ability to Participate in Social Roles Measured by PROMIS-29 | Baseline and Week 16 | PROMIS-29 Ability to Participate in Social Roles T-score. Higher scores indicate better social participation. |
| Change in Functional Capacity Measured by Duke Activity Status Index (DASI) | Baseline and Week 16 | Duke Activity Status Index (DASI) total score estimating functional capacity. Higher scores indicate greater functional capacity. |
| Change in Short Physical Performance Battery (SPPB) Total Score | Baseline to 16 weeks | Total composite score (range 0-12) derived from balance, gait speed, and chair stand components of the Short Physical Performance Battery. Higher scores indicate better physical performance. |
| Change in SPPB Balance Score | Baseline to 16 weeks | Balance subtest score (0-4) from the Short Physical Performance Battery. Higher scores indicate better balance performance. |
| Change in Timed Up and Go (TUG) Test Time | Baseline to 16 weeks | Time in seconds required to stand from a seated position, walk 3 meters, turn, return, and sit down. Lower values indicate better mobility. |
| Change in Two-Minute Step Test Performance | Baseline to 16 weeks | Number of step-raises completed in two minutes, meeting standardized knee-height criteria. Higher values indicate better aerobic endurance. |
| Change in Five-Times Sit-to-Stand (5xSTS) Time | Baseline to 16 weeks | Time in seconds required to complete five consecutive sit-to-stand repetitions from a standard chair without use of arms. Lower values indicate better performance. |
| Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-General (FACT-G) | Baseline and Week 16 | Total score on the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. Higher scores indicate better quality of life. |
| Change in Physical Function Measured by PROMIS-29 | Baseline and Week 16 | PROMIS-29 Physical Function T-score. Higher scores indicate better physical function. |
Countries
United States
Contacts
CONTACTNancy Gell, PhD
Outcome results
None listed