Rectal CancerNCT06565052
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
A study testing Prehabilitation Program in people with Rectal Cancer and Colorectal Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Colorectal Cancer, Rectal Cancer Stage II
- What is being tested?
- Prehabilitation Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.
Who cannot join
- 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.
- Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial.
- Currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Jeffrey Meyerhardt, MD, MPH, 617-632-6855, jeffrey_meyerhardt@dfci.harvard.edu
Jeffrey Meyerhardt, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Joel Goldberg, MD, 617-732-8460, JGOLDBERG1@PARTNERS.ORG
Joel Goldberg, MD
About this study
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
Read the detailed description
This is a non-blinded, randomized control trial to determine the feasibility of a hybrid-model, prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy (chemotherapy and/or radiation) before surgical resection. Investigators hope that prehabilitation will result in improved outcomes after surgery.
Participants will be randomized into one of the study groups: Group A: prehabilitation program, or Group B: usual care. Randomization means that a participant is placed into a group by chance.
The research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires.
It is expected that about 40 participants will take part in this research study.
- Being tested
- Prehabilitation Program
- Keywords
- Rectal Cancer, Colorectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III
- Medical subject headings
- Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Prehabilitation Program | Experimental | Participants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following:
* In-clinic baseline visit with assessments
* Virtual exercise sessions 3 days per week for 4 weeks.
* IMN supplementation and daily multivitamin starting at 4 weeks of the preoperative phase.
* Resection surgery per standard of care
* In-clinic 30 day postoperative visit. Receives: Behavioral: Prehabilitation Program |
| Group B: Usual Care | No intervention | Participants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following: * In-clinic baseline visit with assessments * Resection surgery per standard of care * In-clinic 30 day postoperative visit * After completion of the study period, participants will be offered exercise equipment with an exercise instruction booklet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (33)
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.
Measured: At post-intervention (approximately Week 4)
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.
Measured: At post-intervention (approximately Week 4)
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.
Measured: At post-intervention (approximately Week 4)
Completion Rate of Questionnaire Assessments
Defined as the number of questionnaires completed by all participants.
Measured: At baseline and the postoperative visit (approximately Week 9)
Participant Fall Rate (Group A)
Defined as the number of falls attributable to the exercise and nutrition components of the intervention.
Measured: At post-intervention (approximately Week 4)
Participant Fall Rate (Group B)
Defined as the number of falls attributable to the exercise and nutrition components of the intervention.
Measured: At post-intervention (approximately Week 4)
Rate of Hospitalization (Group A)
Defined as the number of hospitalizations attributable to the exercise and nutrition components of the intervention.
Measured: At post-intervention (approximately Week 4)
Rate of Hospitalization (Group B)
Defined as the number of hospitalizations attributable to the exercise and nutrition components of the intervention.
Measured: At post-intervention (approximately Week 4)
Rate of Musculoskeletal Injury (Group A)
Defined as the number of musculoskeletal injuries attributable to the exercise and nutrition components of the intervention.
Measured: At post-intervention (approximately Week 4)
Rate of Musculoskeletal Injury (Group B)
Defined as the number of musculoskeletal injuries attributable to the exercise and nutrition components of the intervention.
Measured: At post-intervention (approximately Week 4)
Change in Resting Blood Pressure from Baseline to Post-Intervention
Assessed by resting blood pressure. The average systolic blood pressure (of two measurements from each arm) will be recorded.
Measured: From baseline to post-operative visit (approximately week 9)
Change in Cardiorespiratory Fitness from Baseline to Post-Intervention
Assessed by VO2peak by a graded maximal (or submaximal if equipment is unavailable) cycle exercise stress test. VO2peak is defined as the highest values of oxygen uptake averaged among every 30-second interval during the test. VO2peak will be reported in both relative (ml·kg-1·min-1) and absolute (L/min) terms.
Measured: From baseline to post-operative visit (approximately week 9)
Change in Short Physical Performance Battery (SPPB) Score from Baseline to Post-Intervention
Assessed by the Short Physical Performance Battery (SPPB) which is comprised of three sections: 1) balance with feet together, semi tandem, and full tandem is held for up to 10 seconds with no support and measure in seconds. Scores are summed for the measure of balance for a range of 0 to 30 seconds; 2) usual gait speed over four meters is timed (seconds); and 3) chair stand where the time(s) to complete five chair sit-to-stands is recorded. Each of the three performance measures is assigned a score ranging from 0 to 4, with 4 indicating highest level of performance and 0 indicating inability to complete test. A summary score ranging from 0 (worst performers) to 12 (best performers) is calculated by adding walking speed, chair stands and balance scores.
Measured: From baseline to post-operative visit (approximately week 9)
Change in Muscle Strength from Baseline to Post-Intervention
The 1RM (repetition maximum) will be estimated from 10RM muscle strength tests on two exercises: 1) leg press, 2) chest press. 1RM values will be calculated and reported using validated equations.
Measured: From baseline to post-operative visit (approximately week 9)
Change in Height from Baseline to Post-Intervention
Height will be measured using a stadiometer, rounding up to the nearest 0.1 cm
Measured: From baseline to post-operative visit (approximately week 9)
Change in Weight from Baseline to Post-Intervention
Assessed by weight, rounding up to the nearest 0.1 kg.
Measured: From baseline to post-operative visit (approximately week 9)
Change in Waist Circumference from Baseline to Post-Intervention
Waist circumference will be measured, rounding up to the nearest 0.1cm.
Measured: From baseline to post-operative visit (approximately week 9)
Change in Hip Circumference from Baseline to Post-Intervention
Hip circumference will be measured, rounding up to the nearest 0.1cm.
Measured: From baseline to post-operative visit (approximately week 9)
Change in Body Mass Index from Baseline to Post-Intervention
Body composition will be assessed via bioelectrical impedance using a validated device. The device will estimate body fat using an algorithm based on participant age, sex, height, and body weight.
Measured: From baseline to post-operative visit (approximately week 9)
Change in Nutritional Status from Baseline to Post-Surgery (Group A)
Assessed by the Perioperative Nutrition Score (PONS), a validated screening questionnaire that assists in determining risk of malnutrition in the perioperative setting. This is assessed via 1) Body mass index (BMI), which can be calculated through the participant's anthropomorphic measurements, 2) self-reported unplanned changes in weight or decrease in dietary intake, or 3) preoperative albumin level.
Measured: From baseline to postoperative visit, up to 9 weeks
Change in Nutritional Status from Baseline to Post-Surgery (Group B)
Assessed by the Perioperative Nutrition Score (PONS), a validated screening questionnaire that assists in determining risk of malnutrition in the perioperative setting. This is assessed via 1) Body mass index (BMI), which can be calculated through the participant's anthropomorphic measurements, 2) self-reported unplanned changes in weight or decrease in dietary intake, or 3) preoperative albumin level.
Measured: From baseline to postoperative visit, up to 9 weeks
Change in Quality of Life from Baseline to Post-Surgery (Group A)
Assessed by the European Organization for Research and Treatment of Cancer's (EORTC's) Quality of Life (QOL) core questionnaire (QLQ C-30), a validated, 30-item instrument designed to quantify and measure QOL in cancer participants. Questions are rated on a four point scale from 1 "Not at all" to 4 "Very much. All items have a score range from 0 to 100 points. A higher score represents better function and a higher quality of life.
Measured: From baseline to postoperative visit, up to 9 weeks
Change in Quality of Life from Baseline to Post-Surgery (Group B)
Assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19 question measure of 7 domains of sleep quality and patterns of sleep. The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 to 3 points with a 0 indicating no difficulty and 3 indicating severe difficulty. The 7 component scores are added to yield a total score with a range of 0 to 21 points. A total score of 5 or greater is indicative of poor sleep quality.
Measured: From baseline to postoperative visit, up to 9 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) Score from Baseline to Post-Surgery (Group A)
Assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19 question measure of 7 domains of sleep quality and patterns of sleep. The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 to 3 points with a 0 indicating no difficulty and 3 indicating severe difficulty. The 7 component scores are added to yield a total score with a range of 0 to 21 points. A total score of 5 or greater is indicative of poor sleep quality.
Measured: From baseline to postoperative visit, up to 9 weeks
Change in PSQI Score from Baseline to Post-Surgery (Group B)
Assessed by the Pittsburgh Sleep Quality Index (PSQI), a 19 question measure of 7 domains of sleep quality and patterns of sleep. The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 to 3 points with a 0 indicating no difficulty and 3 indicating severe difficulty. The 7 component scores are added to yield a total score with a range of 0 to 21 points. A total score of 5 or greater is indicative of poor sleep quality.
Measured: From baseline to postoperative visit, up to 9 weeks
Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group A)
Assessed by the Clinical Frailty Scale (CFS), which consists of 9 questions assessing specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).
Measured: From baseline to postoperative visit, up to 9 weeks
Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group B)
Assessed by the Clinical Frailty Scale (CFS), which consists of 9 questions assessing specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).
Measured: From baseline to postoperative visit, up to 9 weeks
Length of Hospitalization Post-Surgery (Group A)
Defined as the number of days of hospitalization post-surgery.
Measured: 30 Days
Length of Hospitalization Post-Surgery (Group B)
Defined as the number of days of hospitalization post-surgery.
Measured: 30 Days
Time To Return of Bowel Function Post-Surgery (Group A)
Defined as the number of days to a return of bowl function post-surgery.
Measured: 30 Days
Time To Return of Bowel Function Post-Surgery (Group B)
Defined as the number of days to a return of bowl function post-surgery.
Measured: 30 Days
Discharge Disposition (Group B)
Defined as participant disposition post-surgery: discharge to home, inpatient rehabilitation facility, or other. Data will be summarized using descriptive statistics.
Measured: 30 Days
Discharge Disposition (Group A)
Defined as participant disposition post-surgery: discharge to home, inpatient rehabilitation facility, or other. Data will be summarized using descriptive statistics.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start15 Dec 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey A. Meyerhardt, MD, Dana-Farber Cancer Institute
- Investigators
- Jeffrey Meyerhardt, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565052
- Sponsor's protocol ID
- 24-384
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: The PROPEL Trial
- ClinicalTrials.gov ID
- NCT06565052
- Acronym / sponsor ID
- 24-384
- Keywords
- Rectal Cancer, Colorectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a non-blinded, randomized control trial to determine the feasibility of a hybrid-model, prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy (chemotherapy and/or radiation) before surgical resection. Investigators hope that prehabilitation will result in improved outcomes after surgery.
Participants will be randomized into one of the study groups: Group A: prehabilitation program, or Group B: usual care. Randomization means that a participant is placed into a group by chance.
The research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires.
It is expected that about 40 participants will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Prehabilitation Program | Experimental | Behavioral: Prehabilitation ProgramParticipants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following: * In-clinic baseline visit with assessments * Virtual exercise sessions 3 days per week for 4 weeks. * IMN supplementation and daily multivitamin starting at 4 weeks of the preoperative phase. * Resection surgery per standard of care * In-clinic 30 day postoperative visit. |
| Group B: Usual Care | No intervention | –Participants will be randomized in a 1:1 ratio using a permuted blocked design and stratified by neoadjuvant therapy received. Participants will complete the following: * In-clinic baseline visit with assessments * Resection surgery per standard of care * In-clinic 30 day postoperative visit * After completion of the study period, participants will be offered exercise equipment with an exercise instruction booklet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.
Key exclusion criteria (6 listed)
- 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.
- Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation ProgramA 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. | Behavioural | Group A: Prehabilitation Program |
Primary outcome
Enrollment Rate
Time frame: Baseline
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.
33 secondary outcomes
Adherence Rate to the Prehabilitation Program
Time frame: At post-intervention (approximately Week 4)
Completion Rate of Physical Function Testing (Group A)
Time frame: At post-intervention (approximately Week 4)
Completion Rate of Physical Function Testing (Group B)
Time frame: At post-intervention (approximately Week 4)
Completion Rate of Questionnaire Assessments
Time frame: At baseline and the postoperative visit (approximately Week 9)
Participant Fall Rate (Group A)
Time frame: At post-intervention (approximately Week 4)
Participant Fall Rate (Group B)
Time frame: At post-intervention (approximately Week 4)
Rate of Hospitalization (Group A)
Time frame: At post-intervention (approximately Week 4)
Rate of Hospitalization (Group B)
Time frame: At post-intervention (approximately Week 4)
Rate of Musculoskeletal Injury (Group A)
Time frame: At post-intervention (approximately Week 4)
Rate of Musculoskeletal Injury (Group B)
Time frame: At post-intervention (approximately Week 4)
Change in Resting Blood Pressure from Baseline to Post-Intervention
Time frame: From baseline to post-operative visit (approximately week 9)
Change in Cardiorespiratory Fitness from Baseline to Post-Intervention
Time frame: From baseline to post-operative visit (approximately week 9)
Change in Short Physical Performance Battery (SPPB) Score from Baseline to Post-Intervention
Time frame: From baseline to post-operative visit (approximately week 9)
Change in Muscle Strength from Baseline to Post-Intervention
Time frame: From baseline to post-operative visit (approximately week 9)
Change in Height from Baseline to Post-Intervention
Time frame: From baseline to post-operative visit (approximately week 9)
Change in Weight from Baseline to Post-Intervention
Time frame: From baseline to post-operative visit (approximately week 9)
Change in Waist Circumference from Baseline to Post-Intervention
Time frame: From baseline to post-operative visit (approximately week 9)
Change in Hip Circumference from Baseline to Post-Intervention
Time frame: From baseline to post-operative visit (approximately week 9)
Change in Body Mass Index from Baseline to Post-Intervention
Time frame: From baseline to post-operative visit (approximately week 9)
Change in Nutritional Status from Baseline to Post-Surgery (Group A)
Time frame: From baseline to postoperative visit, up to 9 weeks
Change in Nutritional Status from Baseline to Post-Surgery (Group B)
Time frame: From baseline to postoperative visit, up to 9 weeks
Change in Quality of Life from Baseline to Post-Surgery (Group A)
Time frame: From baseline to postoperative visit, up to 9 weeks
Change in Quality of Life from Baseline to Post-Surgery (Group B)
Time frame: From baseline to postoperative visit, up to 9 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) Score from Baseline to Post-Surgery (Group A)
Time frame: From baseline to postoperative visit, up to 9 weeks
Change in PSQI Score from Baseline to Post-Surgery (Group B)
Time frame: From baseline to postoperative visit, up to 9 weeks
Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group A)
Time frame: From baseline to postoperative visit, up to 9 weeks
Change in Clinical Frailty Scale (CFS) Score from Baseline to Post-Surgery (Group B)
Time frame: From baseline to postoperative visit, up to 9 weeks
Length of Hospitalization Post-Surgery (Group A)
Time frame: 30 Days
Length of Hospitalization Post-Surgery (Group B)
Time frame: 30 Days
Time To Return of Bowel Function Post-Surgery (Group A)
Time frame: 30 Days
Time To Return of Bowel Function Post-Surgery (Group B)
Time frame: 30 Days
Discharge Disposition (Group B)
Time frame: 30 Days
Discharge Disposition (Group A)
Time frame: 30 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Meyerhardt, MD, MPH principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation Program in people with Rectal Cancer and Colorectal Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Meyerhardt, MD, MPH (617-632-6855, jeffrey_meyerhardt@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.