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Colorectal CancerPhase 3NCT03781154

Predictors of Physical Activity Maintenance in Colorectal Cancer Survivors

A Phase 3 study testing Group Exercise in people with Colorectal Cancer, run by University of Colorado, Denver at 4 sites in United States.

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 is a two-arm trial, comparing the effects of a virtual 12-week group-based exercise intervention vs. control group on physical activity, physical fitness, and quality of life in colorectal cancer survivors, and explore multi-level determinants of physical activity maintenance, 6-months after intervention… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Group Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
4 sitesUnited States
Study dates
17 Oct 2019to 26 Jun 2023
Phase
Phase 3
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision to sign and date the consent form
  • Fluent in English
  • Have access to a computer or phone with internet and a camera
  • Stated willingness to comply with all study procedures and be available for the duration of the study
  • Be a male or female aged 40 years or older at time of diagnosis
  • Histologically confirmed cancer of the colon or rectum (stages II-IV) if treated with curative intent, and no current evidence of metastatic disease
  • Completed resection or other surgery 3-24 months prior to enrollment
  • Received chemotherapy and/or radiation therapy within the previous year, with at least 1 cycle of intended chemotherapy completed (does not need to complete all cycles). No plans for additional chemotherapy or radiation therapy.

Who cannot join

  • Current evidence of metastatic disease
  • Existing participation in ≥150 minutes per week of at least moderate intensity PA
  • Known contraindications for exercise or not able to safely participate in exercise
  • Pregnant women (no testing required)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Poudre Valley Hospital

    Fort Collins, Colorado, 800524

  • Colorado State University

    Fort Collins, Colorado, 80523

  • Harmony Campus

    Fort Collins, Colorado, 80528

Other trials in United States

About this study

This study is a two-arm trial, comparing the effects of a virtual 12-week group-based exercise intervention vs. control group on physical activity, physical fitness, and quality of life in colorectal cancer survivors, and explore multi-level determinants of physical activity maintenance, 6-months after intervention completion.

Read the detailed description

Participants will be prospectively assigned or allocated to either a the exercise intervention or a control group for 12-weeks. The control group will be provided with an informational handout from the American Cancer Society describing exercise recommendations and guidelines for cancer survivors. At the end of the study, control group participants will be offered compensation for participation in a community-based cancer specific exercise program (e.g., BfitBwell, Fit Cancer, Livestrong at the YMCA). Supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components. Sessions will be delivered synchronously (i.e., in real-time/live) via Zoom. Exercise will be individualized based on the results of baseline fitness assessments and medical history. The intervention will also include virtual, group-based discussion sessions which operationalize behavior change techniques to increase physical activity. Discussion sessions will take place in the same groups, synchronously, via Zoom.

Being tested
Group Exercise
Keywords
Physical activity, Survivors, Maintenance, Personal Training, Group Mediated Cognitive Behavior
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.

  • Group ExerciseBehavioural

    Patients will exercise in a virtual group for 60 minutes, twice a week. Five social-cognitive theory-based discussion sessions with the group, and group exercise instructor will be held throughout the course of the intervention, lasting 30 to 60 minutes. The goal of these sessions is to enhance long-term physical activity behavior change.

Study groups in NCT03781154
Study groupRoleWhat they receive
Group-based exerciseExperimentalVirtually-delivered supervised exercise sessions will take place twice per week for approximately one hour, and include aerobic, muscular strength and endurance, balance, and flexibility components.
Receives: Behavioral: Group Exercise
Control GroupNo interventionA physical activity education control group

What is being measured

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

  1. Physical Activity

    Compare the effects of a 12-week physical activity intervention delivered in group versus control group, on physical activity. Physical activity will be measured with a self-report questionnaire (duration and frequency of moderate and vigorous physical activity) and accelerometer.

    Measured: From baseline to 12-weeks, and 6 months post intervention

Secondary outcomes (6)

  1. Physical Fitness: Aerobic

    Aerobic fitness will be assessed with a submaximal, graded exercise test on a motorized, calibrated treadmill. Muscular Strength \& Endurance will be assessed by multiple repetition maximum (1RM) plate loaded seated bench press and leg press, and by the number of full stands from a chair, and the number of bicep curls (holding a hand weight of 5lbs) that can be completed in 30 seconds.

    Measured: From baseline to 12-weeks and 6-months post intervention

  2. Physical Fitness: Strength and Endurance

    Muscular strength \& endurance will be assessed by various weight training activities.

    Measured: From baseline to 12-weeks and 6 months post intervention

  3. Body Composition

    Assessed by waist circumference

    Measured: From baseline to 12-weeks 6 months post intervention

  4. Body Composition

    Assessed by the combination of lean mass and fat mass via Dual-Energy X-ray Absorptiometry (DEXA)

    Measured: From baseline to 12 weeks

  5. Sleep Quality

    Assessed by a self-report measure of sleep quality using the Pittsburg Sleep Quality Index (PSQI) and through the Actiwatch, which is a wrist-worn monitor that records movement and light exposure.

    Measured: From baseline to 12 weeks

  6. Quality of Life Assessment

    Assessed by a quantitative self-report questionnaire (Functional Assessment of Cancer Therapy-Colorectal (FACT-C)

    Measured: From baseline to 12 weeks and 6 months post intervention

Timeline

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

  1. First posted19 Dec 2018
  2. Study start17 Oct 2019
  3. Primary completion26 Jun 2023
  4. Study completion26 Jun 2023

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be prospectively assigned or allocated to either the group-based exercise intervention or control group for 12 weeks.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03781154
Sponsor's protocol ID
18-2436.cc
Other IDs
131629-MRSG-18-021- 01-CPPB
Status last verified
Mar 2024
First submitted
14 Dec 2018
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bachman SL, Gomes E, Aryal S, Cella D, Clay I, Lyden K, Leach HJ. Do Measures of Real-World Physical Behavior Provide Insights Into the Well-Being and Physical Function of Cancer Survivors? Cross-Sectional Analysis. JMIR Cancer. 2024 Jul 15;10:e53180. doi: 10.2196/53180.

    PubMed 39008350

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Group Exercise in people with Colorectal Cancer, run by University of Colorado, Denver at 4 sites in United States.

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 8 inclusion and 4 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 20 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 4 sites in United States. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Physical Activity (time frame: From baseline to 12-weeks, and 6 months post intervention). 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 NCT03781154, 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 20 Mar 2024.

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