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Colorectal CancerCCRNCT06593678

Telerehabilitation in Cancer Patients: Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection

A study testing Telerehabilitation Program and Booklet-based rehabilitation program in people with Colorectal Cancer and Telerehabilitation, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study, titled: Telerehabilitation in Oncology Patients: Optimization of Prehabilitation and Rehabilitation Post-Colorectal Resection. Is a randomized clinical trial conducted at the Royo Villanova Hospital in Zaragoza, Spain. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Telerehabilitation Program and Booklet-based rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
30 Aug 2024to 31 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 80 years.
  • Participants who understand Spanish.
  • Patients scheduled for colorectal cancer surgery at Royo Villanova Hospital, Zaragoza, Spain.
  • Patients attending the first consultation in the General and Digestive Surgery Section under the supervision of Dr. Blas, head of surgery at Royo Villanova Hospital, Zaragoza, Spain.
  • Participants with functional independence that allows them to perform walking and pulmonary function tests.
  • Patients with a preoperative assessment score of I, II, or III on the American Society of Anesthesiologists (ASA) scale.
  • Participants who agree to participate and sign the informed consent form.

Who cannot join

  • Patients older than 80 years.
  • Patients with a preoperative ASA score of IV.
  • Patients with any injury, pathology, or inflammatory processes that make it impossible to practice exercise.
  • Patients with central and/or peripheral neurological diseases that prevent them from following the rehabilitation program.
  • Patients with unstable cardiac comorbidities such as arrhythmias, high blood pressure, angina pectoris, or other conditions that contraindicate moderate-intensity training.
  • Patients diagnosed with a psychiatric disorder as confirmed by a psychiatrist.
Show all 10Show fewer
  • Patients without access to mobile internet or a computer with internet at home.
  • Patients who score ≤ 24 on the Mini-Mental State Examination (MMSE).
  • Individuals who are unable to follow oral and written instructions in Spanish.
  • Patients who refuse to participate in the study or who have not signed the informed consent form.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Royo Villanova

    Zaragoza, Zaragoza, 50015

Other trials in Spain

About this study

Official title: Telerehabilitation in Cancer Patients: Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection. A Randomized Clinical Trial

This study, titled: Telerehabilitation in Oncology Patients: Optimization of Prehabilitation and Rehabilitation Post-Colorectal Resection. Is a randomized clinical trial conducted at the Royo Villanova Hospital in Zaragoza, Spain. It aims to evaluate the effectiveness of a tele-rehabilitation program in enhancing functional capacity and quality of life for patients undergoing colorectal cancer surgery. Colorectal cancer (CRC) is a highly prevalent malignant tumor that significantly impacts global health and patients\' quality of life, particularly after surgery. Prehabilitation and postoperative rehabilitation are crucial for recovery, and telerehabilitation offers a promising alternative to improve outcomes in CRC patients.

Read the detailed description

Study Background and Rationale: Colorectal cancer (CRC) is one of the most prevalent malignant tumors worldwide and a leading cause of cancer-related deaths. Despite advancements in surgical and oncological treatments, patients often experience significant postoperative complications and a decline in their quality of life. Prehabilitation, which aims to enhance a patient's functional capacity before surgery, has been identified as a promising approach to improve postoperative outcomes. However, traditional rehabilitation programs are often limited by patient adherence, accessibility, and the availability of resources, especially for those living in rural or underserved areas.

Objective: The primary objective of this study is to determine whether a 2-week prehabilitation and 4-week post-surgical rehabilitation program delivered via asynchronous telerehabilitation software can improve the functional capacity of patients undergoing colorectal cancer surgery, as measured by the Six Minute Walking Test (6MWT). Secondary objectives include assessing changes in body composition, muscle strength, pulmonary capacity, postoperative complications, psychosocial factors (such as quality of life, anxiety, depression, and sleep quality), adherence to the treatment, patient acceptance of the treatment, and the usability of the telerehabilitation platform.

Study Design: This is a single-blind, parallel-group randomized clinical trial. Fifty-six patients scheduled for colorectal cancer surgery will be recruited and randomly assigned to either the control group, which will receive conventional rehabilitation through a booklet, or the intervention group, which will receive the same rehabilitation program through a digital telerehabilitation platform. Both groups will undergo a comprehensive rehabilitation program including therapeutic education, respiratory exercises, aerobic exercises, and strength training.

Methodology: Patients will be assessed at five time points: pre-intervention, the day before surgery, 21 days post-surgery, 50 days post-surgery, and 3-month follow-up. The telerehabilitation platform will allow patients to access exercise videos and therapeutic content asynchronously, with the ability to communicate with their physiotherapists through the platform for guidance and support. The booklet will allow patients to access the program through pictures and text.

Clinical implications: Telerehabilitation represents an innovative approach to overcoming barriers associated with conventional rehabilitation, particularly in improving accessibility for patients in remote areas. By demonstrating the clinical efficacy of telerehabilitation, this study aims to contribute to the optimization of rehabilitation protocols for oncology patients and to provide a scalable model for integrating digital health solutions into routine clinical practice.

Being tested
Telerehabilitation Program, Booklet-based rehabilitation program
Keywords
Colorectal Cancer, Telerehabilitation, Physical Therapy, Functional Recovery, Multimodal program, Quality of life, Psychosocial factors
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telerehabilitation ProgramOther

    Also called Asynchronous Digital Rehabilitation

    Participants in the intervention group will receive a home-based rehabilitation program delivered via an asynchronous digital telerehabilitation platform. The multimodal program is accessible at online platform and it is composed for therapeutic exercises, including aerobic and strength training exercises, aimed at improving functional capacity and quality of life before and after colorectal cancer surgery.

  • Booklet-based rehabilitation programOther

    Also called Printed Guide Rehabilitation

    Participants in the control group will receive a booklet-based rehabilitation program at home, provided through a detailed printed guide (explanatory booklet). This guide includes instructions in pictures and text for the multimodal program. It is composed for therapeutic exercises, including aerobic and strength training exercises, aimed at improving functional capacity and quality of life before and after colorectal cancer surgery.

Study groups in NCT06593678
Study groupRoleWhat they receive
Intervention Group. Asynchronous telerehabilitationExperimentalReceive a home-based rehabilitation program via an asynchronous digital telerehabilitation platform.
Receives: Other: Telerehabilitation Program
Control Group. Booklet-based rehabilitationActive comparatorReceive a booklet-based rehabilitation program at home through a detailed printed guide (explanatory booklet).
Receives: Other: Booklet-based rehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Capacity - Six Minute Walking Test (6MWT)

    The primary outcome is the improvement in functional capacity, which will be evaluated using the Six Minute Walking Test (6MWT). This test measures the maximum distance a patient can walk in six minutes along a flat, straight corridor under controlled conditions. The results provide an objective assessment of the patient\'s functional capacity, reflecting their ability to perform daily activities and their level of postoperative recovery.

    Measured: Functional capacity will be assessed at four time points: pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

Secondary outcomes (13)
  1. Pulmonary Capacity - Spirometry Assessments

    Evaluate improvements in pulmonary capacity using spirometry, with a specific focus on measuring Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) through standardized spirometry techniques.. The aim is to determine whether the tele-rehabilitation program can enhance respiratory function as compared to the standard approach.

    Measured: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

  2. Upper Limb Muscle Strength - Hand Grip Test

    Evaluate the muscle strength of the upper limbs using the Hand Grip Test. This assessment will provide data on the effectiveness of the tele-rehabilitation program in enhancing upper limb muscle strength.

    Measured: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

  3. Lower Limb Muscle Strength - Sit to Stand Test

    Evaluate the muscle strength of the lower limbs using the Sit to Stand Test. This assessment will provide data on the effectiveness of the tele-rehabilitation program in enhancing lower limb muscle strength.

    Measured: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

  4. Body Composition - Bioelectrical Impedance Analysis and Waist-to-Hip Ratio

    Assess changes in body composition, including measurements taken via bioelectrical impedance analysis (BIA) and waist-to-hip ratio. This will help determine if the tele-rehabilitation program leads to significant improvements in body composition compared to the conventional rehabilitation program.

    Measured: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).

  5. Postoperative Complications - Comprehensive Complication Index (CCI)

    Assess the occurrence and severity of postoperative complications using the Comprehensive Complication Index (CCI). The CCI provides a cumulative score that reflects the overall burden of all complications, ranging from 0 (no complications) to 100 (death). This outcome measure aims to determine whether the tele-rehabilitation program effectively reduces the rate and severity of postoperative complications compared to the standard rehabilitation approach.

    Measured: Evaluated 3 months post-surgery (T5).

  6. Quality of Life - EuroQol-5D (EQ-5D)

    Assess the impact on quality of life using the EuroQol-5D (EQ-5D) instrument. The EQ-5D evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores range from -0.594 to 1, where higher scores indicate better quality of life.

    Measured: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).

  7. Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)

    Measure levels of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of two subscales: anxiety and depression, each ranging from 0 to 21. Higher scores indicate worse outcomes.

    Measured: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).

  8. Psychological Adjustment - Mental Adjustment to Cancer Scale (MAC)

    Evaluate psychological adjustment to cancer using the Mental Adjustment to Cancer Scale (MAC). The MAC includes subscales such as fighting spirit, helplessness/hopelessness, anxious preoccupation, fatalism, and avoidance. Scores vary by subscale, generally ranging from 0 to 32 for each subscale. Higher scores on positive subscales, such as fighting spirit, indicate better adjustment, while higher scores on negative subscales, such as helplessness/hopelessness, indicate worse adjustment.

    Measured: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).

  9. Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)

    Assess sleep quality using the Pittsburgh Sleep Quality Index (PSQI). The PSQI measures seven components: sleep duration, sleep disturbances, sleep latency, daytime dysfunction, and more. Scores range from 0 to 21, with higher scores indicating worse sleep quality.

    Measured: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).

  10. Adherence to the Tele-Rehabilitation Program

    Evaluate compliance with the tele-rehabilitation protocol by tracking the percentage of prescribed sessions completed by participants. Compliance data will be recorded in treatment diaries and through the tele-rehabilitation platform. The compliance rate will be calculated as the proportion of completed sessions out of the total prescribed sessions.

    Measured: Monitored continuously throughout pre-intervention (T1) - the day before surgery (T2), 21 days post-surgery (T3) - 50 days post-surgery (T4).

  11. Satisfaction with Tele-Rehabilitation Program

    Assess participant satisfaction with the tele-rehabilitation program using a standardized satisfaction survey. The survey will be recorded on the tele-rehabilitation platform, and scores will range from 1 to 4, with higher scores indicating greater satisfaction.

    Measured: Monitored continuously throughout pre-intervention (T1) - the day before surgery (T2), 21 days post-surgery (T3) - 50 days post-surgery (T4).

  12. Incremental Cost-Effectiveness Ratio (ICER) - Cost per QALY

    Assess the cost-effectiveness of the tele-rehabilitation program compared to conventional clinical practice by calculating the Incremental Cost-Effectiveness Ratio (ICER). The ICER is expressed in euros per Quality-Adjusted Life Year (QALY). This measure will provide insight into the additional cost per QALY gained with the tele-rehabilitation program.

    Measured: Evaluated after 3 months post-surgery (T5).

  13. Quality-Adjusted Life Years (QALYs)

    Evaluate the quality-adjusted life years (QALYs) gained through the tele-rehabilitation program compared to conventional clinical practice. The QALY is a measure of the value of health outcomes, combining both quantity and quality of life. Scores typically range from 0 (equivalent to death) to 1 (perfect health), with higher scores indicating better outcomes.

    Measured: Evaluated after 3 months post-surgery (T5).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start30 Aug 2024
  3. Primary completion17 Apr 2026
  4. Study completion31 Jul 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, sigle-blind randomized clinical trial with two parallel interventions
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06593678
Sponsor's protocol ID
UZ-USJ-CCR
Acronym
CCR
Status last verified
Sep 2025
First submitted
29 Aug 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Burgos-Bragado JM, Jimenez-Sanchez C, Brandin-de la Cruz N, Carpallo-Porcar B, Roux-Etheve LL, Blas-Laina JL, Alamillo-Salas J, Gracia Gimeno P, Calvo S. Asynchronous telerehabilitation in prehabilitation and postoperative recovery for colorectal cancer: A protocol for a randomized controlled trial. PLoS One. 2026 Apr 30;21(4):e0333649. doi: 10.1371/journal.pone.0333649. eCollection 2026.

    PubMed 42060648

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation Program and Booklet-based rehabilitation program in people with Colorectal Cancer and Telerehabilitation, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 2 Oct 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Capacity - Six Minute Walking Test (6MWT) (time frame: Functional capacity will be assessed at four time points: pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06593678, which also lists 1 linked publication.

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 2 Oct 2026.

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