The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Prehabilitation Program

    Behavioral

    A 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

40 Participants
are divided into 2 treatment groups
Group A: Group A: Prehabilitation ProgramExperimental treatment 1 intervention
Group B: Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

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.

Time frame
At post-intervention (approximately Week 4)
2

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.

Time frame
At post-intervention (approximately Week 4)
3

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.

Time frame
At post-intervention (approximately Week 4)
4

Completion Rate of Questionnaire Assessments

Defined as the number of questionnaires completed by all participants.

Time frame
At baseline and the postoperative visit (approximately Week 9)

Other outcomes

Sponsors and contacts

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