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Risk ReductionSTRONG-CSNCT04088968

STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery

A study testing Prehabilitation in people with Risk Reduction and Urological Cancer, run by Bispebjerg Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Despite knowledge about the effect of preventive measures in lifestyle, smoking,nutrition, alcohol and physical activity (SNAP), there is a lack of systematic assessment of the overall lifestyle of the patient before surgery and knowledge about how lifestyle interventions can be organized in connection with cancer… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Risk Reduction, Urological Cancer, Surgery
What is being tested?
Prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteDenmark
Study dates
1 Jan 2022to 31 Dec 2025
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 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients > 18 years scheduled for cystectomy due to bladder cancer
  • Referral to neoadjuvant chemotherapy
  • Screened positive for minimum 1 SNAP factor
  • Signed informed consent

Who cannot join

  • Pregnancy and breastfeeding
  • Allergy to pharmaceutical support (Nicotine Replacement Therapy, Disulfiram)
  • Contraindications to exercise.

Trial locations and contacts

1 site in 1 country.

Hanne Tønnesen, Professor MD contact

+4538163840

hanne.tonnesen@regionh.dk

Susanne V Lauridsen, PhD contact

+4535451704

susanne.vahr.lauridsen@regionh.dk

Denmark1 site, 1 recruiting

  • Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet

    Copenhagen, Region H, 2100

    Susanne V Lauridsen, PhD, +4535451704, susanne.vahr.lauridsen@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation Including Smoking, Nutrition, Alcohol and Physical Activity for Risk Reduction in Cancer Surgery

Despite knowledge about the effect of preventive measures in lifestyle, smoking,nutrition, alcohol and physical activity (SNAP), there is a lack of systematic assessment of the overall lifestyle of the patient before surgery and knowledge about how lifestyle interventions can be organized in connection with cancer surgery. The intention with prehabilitation is to optimize the individual's risk factors and personal burdens that can affect the clinical and patient reported outcomes after surgery. The aim of this study is to evaluate the efficacy of intensive SNAP interventions compared to treatment as usual (TAU) in ptt undergoing urological cancer surgery on surgical risk reduction.

Read the detailed description

The project contains three clinical intervention studies, in total including 100 urological cancer patients screened positive for at least 1 SNAP factor:

  1. Efficacy and preferences of intensive SNAP-Interventions among patients with at least one SNAP factor and undertaking neo-adjuvant chemotherapy before radical cystectomy. A randomised controlled trial with nested interviews (42 patients).

II. Implementation and preferences of intensive SNAP-Interventions among patients with kidney cancer undergoing nephrectomy/partial nephrectomy. An implementation feasibility study including interviews (20 patients).

III. Reach out and effect as well as preferences of perioperative intensive smoking cessation intervention via the municipality clinic compared to the surgical department among smokers with non-invasive bladder cancer treated with Trans-Urethral Resection of the Bladder (TUR-B). A randomised controlled trial with nested interviews (38 patients).

The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.

Being tested
Prehabilitation
Keywords
Postoperative complications, Prehabilitation, Surgical risk reduction, Smoking, Alcohol drinking, Physical activity, Malnutrition, Obesity, Patient preferences, Randomised controlled trial
Medical subject headings
Risk Reduction Behavior, Urologic Neoplasms, Postoperative Complications, Smoking, Alcohol Drinking, Motor Activity, Malnutrition, Obesity

What participants receive

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

  • PrehabilitationBehavioural

    Also called smoking cessation, alcohol cessation, physical activity, nutritional support for malnutrition and obesity

    Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.

Study groups in NCT04088968
Study groupRoleWhat they receive
PrehabilitationExperimentalIntervention: Patients allocated to the intervention group receive weekly counselling sessions in 6 weeks as an integrated prehabilitation program tailored to meet the individual patient's need for risk reduction at surgery. It is introduced via the surgical 'Engage in the process of change'. The smoking and alcohol cessation intervention follows the Gold Standard Programme and patients in the intervention group are introduced to a standardized exercise training programme taking individualized needs into account. Nutritional support is also individualized.
Receives: Behavioral: Prehabilitation
Treatment as usualNo interventionTreatment as ususal covers shorter interventions, e.g. advice, brief counselling, and handing out the national folders on smoking and alcohol and surgery. Patients are ensured that they are free to access support to lifestyle changes in the community.

What is being measured

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

  1. Number of patients with risk reduction at surgery

    Corresponding at least 1 step for 1 or more risky lifestyles (but only smoking in study III) on the ASA-score (American Society of Anaesthesiologists physical status classification from 1-5, lower is better)

    Measured: End of intervention/ at surgery

Secondary outcomes (9)

  1. Health related quality of life (HRQoL)

    Mean difference of HRQoL between groups measured with EQ5D (5 level quality of life score (level 1 =no problems, level 2-5 =problems)

    Measured: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

  2. Number of patients with any postoperative complication

    Scored by the Comprehensive Complication Index, a linear scale ranging from 0 (no complication) to 100 (death)

    Measured: 30 days

  3. Number of successful tobacco quitters

    Successful quitting smoking: Study I+ II+ III

    • Successful quitting alcohol intake at 6 weeks and below risky limits at 6 months: Study I.
    • Physical activity at least 30 minutes per day: Study I.
    • Malnutrition: Not at risk of malnutrition: Study I. Obesity: 5% -10 % loss of body fat mass and below 1% gain of body fat mass at 6 months (without developing malnutrition)

    Measured: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

  4. Number of successful alcohol quitters

    Successful quitting alcohol: Study I+II

    Measured: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

  5. Number of patients being physical active at least 30 min per day

    Minutes physical active measured by an accelerometer (longer time is better) : Study I+II

    Measured: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

  6. Number of patients not at risk of malnutrition

    NRS2002 (Nutritional Risk Screening 2002) score>2. Lower is better: Study I+II

    Measured: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

  7. Number of patients not at risk of obesity

    BMI (Body Mass Index)<30. Lower is better : Study I+II

    Measured: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

  8. Number of patients with improved frailty level

    Measured by Lammers definition: Lower is better: Study I+II+III

    Measured: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

  9. Number of patients with any reduction in lifestyle

    Measured by yes/no. Study I+II+III

    Measured: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

Timeline

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

  1. First posted13 Sep 2019
  2. Study start1 Jan 2022
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

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
Randomised Controlled Trials, Implementation feasibilty trial, Interviews nested
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04088968
Sponsor's protocol ID
STRONG Cancer Surg (COMPAS)
Acronym
STRONG-CS
Status last verified
Mar 2024
First submitted
8 Jul 2019
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tonnesen H, Lydom LN, Joensen UN, Egerod I, Pappot H, Lauridsen SV. STRONG for Surgery & Strong for Life - against all odds: intensive prehabilitation including smoking, nutrition, alcohol and physical activity for risk reduction in cancer surgery - a protocol for an RCT with nested interview study (STRONG-Cancer). Trials. 2022 Apr 21;23(1):333. doi: 10.1186/s13063-022-06272-2.

    PubMed 35449008

Questions about this trial

What is this clinical trial studying?

A study testing Prehabilitation in people with Risk Reduction and Urological Cancer, run by Bispebjerg Hospital at 1 site in Denmark.

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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. 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 Denmark. 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?

Results are not available in the source record.

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

Contact Hanne Tønnesen, Professor MD (+4538163840, hanne.tonnesen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with risk reduction at surgery (time frame: End of intervention/ at surgery). 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 NCT04088968, 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 22 Mar 2024.

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