Colorectal CancerNCT07922642
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
A study testing Nurse-Led Multimodal Prehabilitation Program in people with Colorectal Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
Many people who have major planned surgery for abdominal cancer develop complications afterwards, which can prolong hospital stay and slow recovery. This study tests whether a four-week program led by a trained oncology nurse, started before surgery, reduces these complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Nurse-Led Multimodal 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
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2026to Mar 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
- Adults aged 18 years or older
- Histologically confirmed or suspected abdominal cancer (colorectal, gastric, pancreatic or hepatobiliary, or other major abdominal resection)
- Scheduled for elective major open or laparoscopic abdominal surgery, with at least 3 weeks between enrollment and the planned surgery date
- ECOG performance status 0 to 2
- Able to give written informed consent and communicate in Arabic
Who cannot join
- Emergency or urgent surgery
- Unstable cardiac or respiratory disease, or any medical contraindication to exercise as judged by the treating physician
- Severe musculoskeletal or neurological condition preventing walking
- Cognitive impairment that prevents following the program or completing questionnaires
- Already participating in a structured exercise program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of a Nurse-Led Multimodal Prehabilitation Program on Postoperative Complications in Patients Undergoing Major Elective Abdominal Cancer Surgery: A Mixed-Methods Randomized Controlled Trial
Many people who have major planned surgery for abdominal cancer develop complications afterwards, which can prolong hospital stay and slow recovery. This study tests whether a four-week program led by a trained oncology nurse, started before surgery, reduces these complications. The program combines supervised and home exercise (walking, resistance and breathing exercises), nutrition counseling with protein targets and supplements when needed, education and relaxation techniques to reduce anxiety, and advice on stopping smoking and alcohol. Adults at one hospital will be randomly assigned, in equal numbers, to the program plus usual care or to usual care alone; 104 participants are planned. The main outcome is the Comprehensive Complication Index, a score from 0 to 100 that combines all complications within 30 days after surgery, graded by an assessor who does not know the group. Other outcomes include serious complications, distance walked in six minutes, quality of life, length of hospital stay, hospital readmission, time to first getting out of bed, and adherence to the program. In a qualitative part, 12 to 15 participants from the program group will be interviewed about their experiences, barriers and acceptability. Results from both parts will be combined to interpret the findings.
- Conditions
- Colorectal Cancer
- Being tested
- Nurse-Led Multimodal Prehabilitation Program
- Keywords
- prehabilitation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Multimodal Prehabilitation ProgramBehavioural
A four-week program delivered by a trained oncology nurse from enrollment until the day before surgery, with a weekly nurse contact (in person or by phone) that reinforces the program and records adherence. Components: (1) Exercise: aerobic brisk walking 30 minutes, 5 days per week at moderate intensity (Borg rating of perceived exertion 11 to 14), resistance exercises 2 to 3 days per week, and daily breathing exercises, taught in a weekly supervised session and continued at home. (2) Nutrition: counseling guided by the Malnutrition Universal Screening Tool, protein target 1.2 to 1.5 g/kg/day, and oral nutritional supplements for medium or high risk, with counseling at baseline and weekly follow-up. (3) Psychological and educational: one preoperative education session about surgery and recovery plus weekly reinforcement, with relaxation and anxiety-reduction techniques. (4) Lifestyle: smoking and alcohol cessation advice where relevant, at baseline and weekly.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Led Multimodal Prehabilitation | Experimental | Usual preoperative care according to hospital routine plus a four-week nurse-led multimodal prehabilitation program, delivered from enrollment until the day before surgery. If fewer than 4 weeks are available, the program is delivered for the available time (minimum 3 weeks for per-protocol analysis). Surgery and postoperative care follow the hospital protocol for both groups. Receives: Behavioral: Nurse-Led Multimodal Prehabilitation Program |
| Usual Care | No intervention | Usual preoperative care according to hospital routine, with no structured prehabilitation program. Participants are asked not to start a structured exercise or nutrition program, undergo the same assessments as the intervention arm, and are offered the education material after the 6 to 8 week follow-up visit. Surgery and postoperative care follow the hospital protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication Index (CCI)
Comprehensive Complication Index, a single score for each patient from 0 (no complication) to 100 (death), calculated from all postoperative complications within 30 days after surgery graded by the Clavien-Dindo classification. Higher scores mean worse outcomes. Graded from the medical record by an assessor masked to group.
Measured: Postoperative day 30
Secondary outcomes (3)
Major Complications
Proportion of patients with at least one major complication, defined as Clavien-Dindo Grade III to V
Measured: Postoperative day 30
Change in 6-Minute Walk Distance, Baseline to Pre-Operative
Change in distance walked in 6 minutes (meters) between baseline (T0) and 24 to 48 hours before surgery (T1). Higher is better
Measured: From baseline (T0) to 24 to 48 hours before surgery (T1)
Health-Related Quality of Life (EORTC QLQ-C30, version 3.0)
Change in scores from baseline (T0) to follow-up (T3). All scales are transformed to 0 to 100. Higher scores on functional scales and global health status mean better functioning, and higher scores on symptom scales mean more symptoms
Measured: Baseline (T0) and 6 to 8 weeks after surgery (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start10 Nov 2026 (estimated)
- Primary completion5 Feb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Model description
- Single-center, two-arm, parallel-group randomized controlled trial with 1:1 allocation, using permuted blocks of 4 and 6 (randomly varied) stratified by surgery type (colorectal versus upper gastrointestinal/hepatopancreatobiliary). The sequence is computer-generated by an independent statistician and concealed in sequentially numbered, opaque, sealed envelopes opened only after baseline assessment. A qualitative strand (12 to 15 interviews with intervention-group participants) runs in a convergent mixed-methods design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fakhry Ahmed Salem, Alexandria University
- Investigators
- Mohamed Fakhry Ahmed Salem, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922642
- Sponsor's protocol ID
- PREHAB-ABD-CA-RCT-2026
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nurse-Led Multimodal Prehabilitation Program on Postoperative Complications in Patients Undergoing Major Elective Abdominal Cancer Surgery: A Mixed-Methods Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07922642
- Acronym / sponsor ID
- PREHAB-ABD-CA-RCT-2026
- Conditions
- Colorectal Cancer
- Keywords
- prehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 5 Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
Many people who have major planned surgery for abdominal cancer develop complications afterwards, which can prolong hospital stay and slow recovery. This study tests whether a four-week program led by a trained oncology nurse, started before surgery, reduces these complications. The program combines supervised and home exercise (walking, resistance and breathing exercises), nutrition counseling with protein targets and supplements when needed, education and relaxation techniques to reduce anxiety, and advice on stopping smoking and alcohol. Adults at one hospital will be randomly assigned, in equal numbers, to the program plus usual care or to usual care alone; 104 participants are planned. The main outcome is the Comprehensive Complication Index, a score from 0 to 100 that combines all complications within 30 days after surgery, graded by an assessor who does not know the group. Other outcomes include serious complications, distance walked in six minutes, quality of life, length of hospital stay, hospital readmission, time to first getting out of bed, and adherence to the program. In a qualitative part, 12 to 15 participants from the program group will be interviewed about their experiences, barriers and acceptability. Results from both parts will be combined to interpret the findings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, two-arm, parallel-group randomized controlled trial with 1:1 allocation, using permuted blocks of 4 and 6 (randomly varied) stratified by surgery type (colorectal versus upper gastrointestinal/hepatopancreatobiliary). The sequence is computer-generated by an independent statistician and concealed in sequentially numbered, opaque, sealed envelopes opened only after baseline assessment. A qualitative strand (12 to 15 interviews with intervention-group participants) runs in a convergent mixed-methods design.
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Multimodal Prehabilitation | Experimental | Behavioral: Nurse-Led Multimodal Prehabilitation ProgramUsual preoperative care according to hospital routine plus a four-week nurse-led multimodal prehabilitation program, delivered from enrollment until the day before surgery. If fewer than 4 weeks are available, the program is delivered for the available time (minimum 3 weeks for per-protocol analysis). Surgery and postoperative care follow the hospital protocol for both groups. |
| Usual Care | No intervention | –Usual preoperative care according to hospital routine, with no structured prehabilitation program. Participants are asked not to start a structured exercise or nutrition program, undergo the same assessments as the intervention arm, and are offered the education material after the 6 to 8 week follow-up visit. Surgery and postoperative care follow the hospital protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Histologically confirmed or suspected abdominal cancer (colorectal, gastric, pancreatic or hepatobiliary, or other major abdominal resection)
- Scheduled for elective major open or laparoscopic abdominal surgery, with at least 3 weeks between enrollment and the planned surgery date
- ECOG performance status 0 to 2
- Able to give written informed consent and communicate in Arabic
Key exclusion criteria (5 listed)
- Emergency or urgent surgery
- Unstable cardiac or respiratory disease, or any medical contraindication to exercise as judged by the treating physician
- Severe musculoskeletal or neurological condition preventing walking
- Cognitive impairment that prevents following the program or completing questionnaires
- Already participating in a structured exercise program
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 |
|---|---|---|
| Nurse-Led Multimodal Prehabilitation ProgramA four-week program delivered by a trained oncology nurse from enrollment until the day before surgery, with a weekly nurse contact (in person or by phone) that reinforces the program and records adherence. Components: (1) Exercise: aerobic brisk walking 30 minutes, 5 days per week at moderate intensity (Borg rating of perceived exertion 11 to 14), resistance exercises 2 to 3 days per week, and daily breathing exercises, taught in a weekly supervised session and continued at home. (2) Nutrition: counseling guided by the Malnutrition Universal Screening Tool, protein target 1.2 to 1.5 g/kg/day, and oral nutritional supplements for medium or high risk, with counseling at baseline and weekly follow-up. (3) Psychological and educational: one preoperative education session about surgery and recovery plus weekly reinforcement, with relaxation and anxiety-reduction techniques. (4) Lifestyle: smoking and alcohol cessation advice where relevant, at baseline and weekly. | Behavioural | Nurse-Led Multimodal Prehabilitation |
Primary outcome
Comprehensive Complication Index (CCI)
Time frame: Postoperative day 30
Comprehensive Complication Index, a single score for each patient from 0 (no complication) to 100 (death), calculated from all postoperative complications within 30 days after surgery graded by the Clavien-Dindo classification. Higher scores mean worse outcomes. Graded from the medical record by an assessor masked to group.
3 secondary outcomes
Major Complications
Time frame: Postoperative day 30
Change in 6-Minute Walk Distance, Baseline to Pre-Operative
Time frame: From baseline (T0) to 24 to 48 hours before surgery (T1)
Health-Related Quality of Life (EORTC QLQ-C30, version 3.0)
Time frame: Baseline (T0) and 6 to 8 weeks after surgery (T3)
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 6 Nov 2026.
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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.
Mohamed Fakhry Ahmed Salem principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Multimodal Prehabilitation Program in people with Colorectal Cancer, run by Alexandria University at 1 site in Egypt.
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 5 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 Mohamed Fakhry Ahmed Salem, PhD (01286038014, Mohamed.Fakhry@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index (CCI) (time frame: Postoperative day 30). 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 6 Nov 2026.