About this trial
The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection.
The names of the groups in this research study are:
* Group A: Prehabilitation program * Group B: Usual Care
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than or equal to 18 years at time of enrollment.
English-Speaking.
Diagnosis of clinical stage II-III rectal cancer.
Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow.
Disqualifiers
Distant metastatic disease known at the time of diagnosis.
Functional incapacity (i.e., incapable of performing exercise testing).
Comorbid conditions or cognitive/physical impairments that contraindicate exercise.
Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer.
Trial design
Parallel
Treatments tested in this trial
Prehabilitation Program
BehavioralA hybrid-based, prehabilitation regimen comprised of nutritional optimization (multivitamin and protein supplement shake) and virtual, aerobic and resistance exercise sessions with clinical exercise physiologists. Virtual exercise sessions will be performed via a HIPAA-compliant videoconferencing platform or by phone call. Mini-exercise cycle ergometer, dumbbells, and resistance bands will be provided and delivered to participant. Heart rate monitors and wi-fi enable tablet will be provided if needed.
Treatment groups
Trial outcomes
Primary outcomes
Enrollment Rate
The proportion of eligible individuals that are enrolled to the study. Feasibility of the intervention is defined as an enrollment rate of greater than 10% of approached, eligible participants.
Secondary outcomes
Adherence Rate to the Prehabilitation Program
The number of intervention assessments completed by participants in Group A. Feasibility of the intervention is defined as at least 50% of participants adhering to at least 50% of the prescribed assessments of the prehabilitation program.
Completion Rate of Physical Function Testing (Group A)
Defined as the number of testing assessments (resting blood pressure, measure of cardiorespiratory fitness, Short Physical Performance Battery, muscular strength, and anthropometric measures) completed by participants.
Completion Rate of Physical Function Testing (Group B)
Defined as the number of testing assessments (resting blood pressure, measure of cardiorespiratory fitness, Short Physical Performance Battery, muscular strength, and anthropometric measures) completed by participants.
Completion Rate of Questionnaire Assessments
Defined as the number of questionnaires completed by all participants.
Sponsors and contacts
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