An interventional study of Exercise intervention and Telemedicine in Localized Malignant Solid Neoplasm, Anal Cancer and Bladder (Urothelial, Transitional Cell) Cancer, sponsored by Alliance for Clinical Trials in Oncology. Recruiting at 30 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Alliance for Clinical Trials in Oncology · Not applicable, Interventional, and Supportive care
This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.
PRIMARY OBJECTIVES:
I. To establish the feasibility of implementing a virtual exercise intervention trial in a diverse cohort of cancer patients undergoing chemotherapy.
SECONDARY OBJECTIVE:
I. To establish feasibility of enrolling and retaining a diverse patient population.
EXPLORATORY OBJECTIVES:
I. Evaluate changes in 6 Minute Walk Test (6MWT) distance in the study population between baseline and the post-chemotherapy time point.
II. Evaluate changes in grip strength in the study population between baseline and the post-intervention time point.
III. Evaluate objective (accelerometer) and self-reported changes (7-Day Physical Activity Recall Interview) in physical activity in the study population between baseline and the post-intervention time point.
IV. Explore the relationship between the predicted 6MWT and the baseline 6MWT. V. Explore changes in patient reported outcomes between baseline, end of intervention, and 3-months post intervention in the study population.
VI. Explore employment status over time in the study population.
VII. Explore differences intervention adherence and attrition by:
OUTLINE:
Patients complete supervised TH exercise sessions consisting of aerobic exercise over 20 minutes and progressive resistance exercise twice a week (BIW) and complete unsupervised aerobic exercise for a total of 50 minutes per week until the end of standard of care (SOC) chemotherapy or up to a total of 6 months, whichever comes first, in the absence of disease progression or unacceptable toxicity. Patients also receive a stationary bike, workbook, gloves, and resistance bands on study and wear an accelerometer throughout the study.
After completion of study intervention, patients are followed up at 4 weeks and 3 months.
297 studies on the registry are indexed under Anus Neoplasms; 74 are open to participants now.
This study's planned enrollment of 104 is above the median of 66 across 211 interventional studies indexed under Anus Neoplasms.
Browse Anus Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 509 studies on the registry; 28 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:
* Providing clinical care for participating patients on this study
Exclusion Criteria:
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients complete supervised TH exercise sessions consisting of progressive resistance exercise BIW and complete unsupervised aerobic exercise sessions over 30 minutes TIW until the end of SOC chemotherapy or up to a total of 6 months, whichever comes first, in the absence of disease progression or unacceptable toxicity. Patients also receive adjustable-weight dumbbells on study and wear an accelerometer throughout the study.
Other: Exercise intervention · Other: Telemedicine · Other: Aerobic Exercise Intervention · Procedure: Accelerometry · Other: Questionnaire Administration · Other: Interview · Other: Electronic Health Record Review
Complete supervised TH aerobic and progressive resistance exercise sessions
Complete supervised TH aerobic and progressive resistance exercise sessions
Also known as: Telehealth
Complete unsupervised aerobic exercise
Receive stationary bike, workbook, gloves, and resistance bands
Wear accelerometer
Ancillary studies
Ancillary studies
Ancillary studies
Percentage of completed exercise sessions (Feasibility)
Feasibility will be defined through intervention adherence. Will set a priori thresholds for this outcome to define success as detailed. For evaluating the uptake of the intervention, will assess the percentage of enrolled participants who complete at least 70% of prescribed exercise sessions. Will calculate the proportion of participants meeting this threshold and compare it to the predefined success criterion of 80%. Descriptive statistics (percentages) will be reported along with 95% confidence intervals.
Time frame: Up to 6 months
Intervention attrition rate (Feasibility)
Feasibility will be defined through intervention attrition. Will set a priori thresholds for this outcome to define success as detailed. To examine attrition from the trial, will calculate the attrition rate by dividing the number of participants who drop out of the trial by the total number of enrolled participants. The a priori acceptable attrition rate is no greater than 20%. Descriptive statistics (attrition rate) will be presented, and a comparison with the predefined threshold will be made.
Time frame: Up to 6 months
Weekly recruitment rate
Feasibility of enrolling a diverse patient population will be defined by: Enrolling 80 patients over a 58-week time period, from the date that the study is activated at all 4 enrolling sites and the first patient is enrolled. Descriptive statistics (mean, standard deviation) will be reported for weekly recruitment, along with graphical representations of recruitment trends over time.
Time frame: From the date that the study is activated at all 4 enrolling sites and the first patient is enrolled, assessed up to 58 weeks
Retaining a diverse patient population
Descriptive statistics (percentages) will be summarized for patients who meet at least one of the following criteria: Racial or ethnic minority status (African American, Hispanic, Native American, Pacific Islander), low socioeconomic status (defined as residing in an area in one of the top two quintiles of the Neighborhood Deprivation Index), residing in a rural area (Rural-Urban Continuum Codes or Rural-Urban Commuting Area Code, code 4-10).
Time frame: From the date that the study is activated at all 4 enrolling sites and the first patient is enrolled, assessed up to 58 weeks
Change in 6 Minute Walk Test (6MWT) distance
Descriptive statistics (mean, standard deviation) will be used to summarize changes in 6MWT distance in the study population between baseline and the post-intervention time point.
Time frame: From baseline to end of intervention, which is defined as end of chemotherapy (within 4 weeks of the final chemotherapy administration) or up to a total of 6 months of intervention, whichever comes first
Change in grip strength
Descriptive statistics (mean, standard deviation) will be used to summarize changes in grip strength in the study population between baseline and the post-intervention time point
Time frame: From baseline to end of intervention, which is defined as end of chemotherapy (within 4 weeks of the final chemotherapy administration) or up to a total of 6 months of intervention, whichever comes first
Objective changes in physical activity
Descriptive statistics (mean, standard deviation) will be used to summarize changes in objectively measured physical activity using the accelerometer, including average daily step count, average daily minutes of sedentary time, light activity, and moderate-to-vigorous activity.
Time frame: From baseline to end of intervention, which is defined as end of chemotherapy (within 4 weeks of the final chemotherapy administration) or up to a total of 6 months of intervention, whichever comes first
Self-reported changes in physical activity
Descriptive statistics (mean, standard deviation) will be used to summarize self-reported changes (7-Day Physical Activity Recall Interview) in physical activity in the study population between baseline and the post-intervention time point.
Time frame: From baseline to end of intervention, which is defined as end of chemotherapy (within 4 weeks of the final chemotherapy administration) or up to a total of 6 months of intervention, whichever comes first
Relationship between predicted 6MWT and baseline 6MWT
Person correlation coefficient will be used to summarize the relationship between the predicted 6MWT and the baseline 6MWT.
Time frame: At baseline
Changes in patient reported outcomes
Descriptive statistics (mean, standard deviation) will be used to summarize changes in patient reported outcomes between baseline, end of intervention, and 3-months post intervention in the study population.
Time frame: From baseline to end of intervention, which is defined as end of chemotherapy (within 4 weeks of the final chemotherapy administration) or up to a total of 6 months of intervention, whichever comes first
Employment status
Descriptive statistics (frequency table) histogram will be used to explore the employment status over time in the study population.
Time frame: Up to 3-months post-intervention
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Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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