RE-FIT (Remote Exercise for Physical Function in WTC Responders With Prostate Cancer)
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age55+
SponsorUniversity of Vermont
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Metastatic cancer
Unable to ambulate independently, with or without an assistive device
Moderate or severe cognitive impairment
Unable to communicate in English
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Supervised Exercise Program
BehavioralIntervention 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Remote Exercise InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment Rate
Proportion of eligible participants who enroll in the study among those approached for participation. Unit of Measure: Percentage (%)
Time frame
Recruitment assessed from study start through completion of enrollment (up to 24 months)2
Retention Rate
Proportion of enrolled participants who complete the 16-week post-intervention assessment. Unit of Measure: Percentage (%)
Time frame
From study start through completion of enrollment (up to 24 months)3
Intervention Adherence
Mean percentage of planned exercise sessions attended among participants randomized to the intervention arm (48 planned sessions over 16 weeks). Unit of Measure: Percentage (%)
Time frame
Weeks 1-16 of the intervention period4
Assessment Completion Rate
Proportion of participants completing baseline and post-intervention assessments (physical function testing and questionnaires). Unit of Measure: Percentage (%).
Time frame
Baseline through 16-week post-intervention assessmentSecondary outcomes
1
Change in Five-Times Sit-to-Stand (5xSTS) Time
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.
Time frame
Baseline to 16 weeks2
Change in Quality of Life Measured by Functional Assessment of Cancer Therapy-General (FACT-G)
Total score on the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. Higher scores indicate better quality of life.
Time frame
Baseline and Week 163
Change in Physical Function Measured by PROMIS-29
PROMIS-29 Physical Function T-score. Higher scores indicate better physical function.
Time frame
Baseline and Week 164
Change in Fatigue Measured by PROMIS-29
PROMIS-29 Fatigue T-score. Higher scores indicate worse fatigue.
Time frame
Baseline and Week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Vermont
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborator
Source ClinicalTrials.gov
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