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Colorectal CancerNCT04248647

Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection.

A study testing Multimodal prehabilitation in people with Colorectal Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.

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

Psychological distress is common among adults newly diagnosed with cancer and those awaiting cancer treatment(s). Although preoperative psychological distress has been shown to be associated with poorer physical health and adverse treatments among colorectal cancer survivors, few psychological interventions have been… 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?
Multimodal prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
26 Oct 2016to 1 Apr 2018
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently aged 18 years or older
  • Diagnosed with non-metastatic, colorectal cancer
  • Awaiting resection of malignant colorectal lesions
  • Able to provide informed consent in English or in French

Who cannot join

  • Have health condition(s) interfering with ability to safely perform exercise at home or to complete testing procedures (e.g., non-ambulatory, dementia, severe end-organ disease, morbid obesity, cardiac abnormalities)

About this study

Official title: Surgical Prehabilitation of Cancer Patients Undergoing Colorectal Resection. Modalities to Mitigate the Level of Anxiety and Depression Prior to Surgery.

Psychological distress is common among adults newly diagnosed with cancer and those awaiting cancer treatment(s). Although preoperative psychological distress has been shown to be associated with poorer physical health and adverse treatments among colorectal cancer survivors, few psychological interventions have been developed to reduce distress, and improve physical health in the preoperative period. Moreover, whether a preoperative psychological intervention, delivered in addition to a multimodal Prehabilitation program can improve psychological and physical health remains unknown. Therefore, the purpose of this pilot cohort study was to examine the impact of a structured psychological intervention, given in addition to standard Prehabilitation, on preoperative psychological health and functional capacity in colorectal cancer patients awaiting surgery.

Read the detailed description

All participants will receive a multimodal prehabilitation program preoperatively for 4 weeks, composed of three elements: aerobic and strength training exercise program, nutritional counselling and psychological support. The exercise program will be three times per week and include a combination of home-based (twice per week) and supervised (once per week) sessions. Participants' nutritional status and dietary intake will be assessed by a registered dietician/nutritionist, and a whey protein supplement (Immunocal) will be prescribed to achieve a daily intake of 1.5 g protein/kg. Psychological support will consist of a 90-minute interview/session at baseline and weekly in-person follow-ups before surgery aimed at reducing psychological distress and improving adherence to the exercise program and nutritional recommendations. Perioperative care will follow the McGill Surgical Recovery Pathway, also called Enhanced Recovery Program, which is an evidence-based care plan set up by the Surgical Recovery (SuRe) multidisciplinary committee of the McGill University Health Centre.

Being tested
Multimodal prehabilitation
Keywords
Psychological prehabilitation, Colorectal cancer, Functional capacity, Physical activity, Nutrition, Psychological counselling
Medical subject headings
Colorectal Neoplasms, Motor Activity

What participants receive

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

  • Multimodal prehabilitationBehavioural

    This arm will receive a 4-week prehabilitation program consisting of:

    Exercise: Participants will receive a 3x/week aerobic and strength training exercise program. They will perform 2 workouts per week at home and attend an in-hospital supervised exercise session once per week.

    Nutritional counselling: Participants will meet with a registered dietician who will provide personalized nutritional recommendations and a whey protein supplement, tailored according to participants' self-reported dietary intake and anthropometric measurements.

    Psychological support: Participants will receive a 90-minute session at baseline, and weekly in-hospital follow-ups throughout the preoperative period. The sessions will aim to reduce preoperative distress and improve adherence to the exercise program and nutritional recommendations. Psychological support will be delivered by a trained master's student, under the direct supervision of a registered Clinical Psychologist.

Study groups in NCT04248647
Study groupRoleWhat they receive
Intervention GroupExperimental4-week multimodal preoperative intervention (i.e., Prehabilitation) consisting of an aerobic and strength training program, nutritional counselling and psychological support to help improve physical and psychological health prior to surgical resection of colorectal cancer.
Receives: Behavioral: Multimodal prehabilitation

What is being measured

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

  1. Functional capacity: Six-minute walk test (Enright, 2003)

    Change in participants' performance on the six-minute walk test (6MWT) across baseline (week 0), and post-intervention (week 4). The 6MWT measures the distance an individual can walk, in metres, in a 6-minute period. Greater distance walked during the 6MWT indicates greater functional capacity.

    Measured: Baseline (week 0), post-intervention (week 4)

Secondary outcomes (6)

  1. Postoperative complications: Clavien Classification (Dindo, Demartines & Clavien, 2004)

    Postoperative complications (e.g., pneumonia, urinary tract infection, hemorrhage, bile leak) following colorectal resection will be measured and scored using the Clavien Classification. Each complication is graded between I ('Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy') to V ('Death of a patient') with higher grades indicating greater severity of complication.

    Measured: 8-weeks post-surgery (week 12)

  2. Depressive and anxiety symptoms: The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)

    Change in participants' self-reported anxiety and depressive symptoms across baseline (week 0), and post-intervention (week 4). Each item is scored on a 0 (e.g., 'Definitely as much') to 4 (e.g., 'Hardly at all') scale with higher scores representing greater severity of anxiety and depressive symptoms.

    Measured: Baseline (week 0), post-intervention (week 4)

  3. Health related quality of life: RAND 36-item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992)

    Change in participants' self-reported quality of life across baseline (week 0), and post-intervention (week 4). The SF-36 measures eight dimensions: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each item is scored on a 0-100 scale, with higher scores representing a more favourable health state.

    Measured: Baseline (week 0), post-intervention (week 4)

  4. Physical activity: Community Health Activities Model Program for Seniors (CHAMPS; Stewart et al., 2001)

    Change in participants' self-reported physical activity levels across baseline (week 0), and post-intervention (week 4). CHAMPS measures the average number of hours individuals report engaging in 41 different activities (or varying intensities) during a typical week. Metabolic equivalent of task (MET) scores are calculated for activities engaged in at mild, moderate and vigorous intensity with higher scores indicating higher levels of engagement.

    Measured: Baseline (week 0), post-intervention (week 4)

  5. Lower body strength: Sit-to-Stand test (Bohannon, 1995)

    Change in participants' objective performance on the sit-to-stand test across baseline (week 0), and post-intervention (week 4). The sit-to-stand test measures lower body strength by recording the maximum number of times an individual can go from a seated position to a standing position, without using their arms, in a 30-second period.

    Measured: Baseline (week 0), post-intervention (week 4)

  6. Nutritional status: body weight loss, serum albumin, hand grip strength, body mass index, lean body mass and percentage of body fat

    Change in nutritional status across baseline (week 0), and post-intervention (week 4). Body mass index (kg/m2), lean body mass and percentage of body fat will be measured using a bioimpedance machine. Self-reported body weight loss in the preceding three months will be recorded. Serum albumin will be measured via blood draw.

    Measured: Baseline (week 0), post-intervention (week 4)

Timeline

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

  1. First posted30 Jan 2020
  2. Study start26 Oct 2016
  3. Primary completion1 Apr 2018
  4. Study completion1 Apr 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248647
Sponsor's protocol ID
MMPI/2017-2840
Status last verified
Jan 2020
First submitted
28 Jan 2020
Last updated
30 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.

    PubMed 8275167

  • Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41. doi: 10.1097/00005768-200107000-00010.

    PubMed 11445760

  • Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.

    PubMed 12890299

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

  • Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.

    PubMed 7624188

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal prehabilitation in people with Colorectal Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.

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 4 inclusion and 1 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 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

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 walk test (Enright, 2003) (time frame: Baseline (week 0), post-intervention (week 4)). 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 NCT04248647, which also lists 6 linked publications.

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 Jan 2020.

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