An interventional study of Nurse-Led Multimodal Prehabilitation Program in Colorectal Cancer, sponsored by Alexandria University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 104 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Behavioral: Nurse-Led Multimodal Prehabilitation Program
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.
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.
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.
Time frame: Postoperative day 30
Major Complications
Proportion of patients with at least one major complication, defined as Clavien-Dindo Grade III to V
Time frame: 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
Time frame: 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
Time frame: Baseline (T0) and 6 to 8 weeks after surgery (T3)
Participant Experiences of the Program (Qualitative)
Experiences, adherence, barriers and acceptability explored in semi-structured individual interviews with 12 to 15 intervention-group participants, analyzed by reflexive thematic analysis
Time frame: After the 6 to 8 week follow-up visit (T3)
Start is estimated for Nov 2026; primary completion for Feb 2027, 2 months later.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 2 months is below that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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 ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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