Colorectal CancerNCT02191969
Physical Activity Intervention for Older Patients During Chemotherapy for Colorectal Cancer
A study testing Walk With Ease in people with Colorectal Cancer and Fatigue, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study will see if patient who undergo a physical activity intervention called Walk With Ease report experiencing less fatigue and a higher quality of life during chemotherapy for colorectal cancer than those who do not participate in this intervention. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colorectal Cancer, Fatigue
- What is being tested?
- Walk With Ease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 18 Sep 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ Age 60 years (no upper age limit)
- Diagnosis of stage II-III colon or rectal cancer planned for treatment with adjuvant chemotherapy scheduled as part of standard treatment
- Able to read English (required for CGA and other surveys administered)
- Approval from their treating physician to engage in moderate-intensity physical activity
- Patient-assessed ability to walk and engage in moderate physical activity
- Signed, IRB-approved written informed consent
Who cannot join
- Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy
- Already walking or engaging in other physical activity >120 minutes per week as documented via subject self-report
- Unable to walk or engage in moderate-intensity physical activity
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial
This study will see if patient who undergo a physical activity intervention called Walk With Ease report experiencing less fatigue and a higher quality of life during chemotherapy for colorectal cancer than those who do not participate in this intervention.
Read the detailed description
The primary purpose of this multicenter, randomized controlled study is to evaluate the impact of a physical activity program on fatigue in older patients (≥60 years) undergoing adjuvant chemotherapy for colorectal cancer. The investigators also plan to evaluate physical function and quality of life as secondary objectives. The investigators' hypotheses are that people who undergo the physical activity intervention compared to those who do not, will: 1) report less fatigue, 2) report higher health related quality of life, and 3) have less decline in physical function. Additionally, The investigators will characterize ≥grade 3 adjuvant chemotherapy associated toxicities in this older population, and describe the changes reported in fatigue, physical function, and HRQOL over the course of chemotherapy.
- Conditions
- Colorectal Cancer, Fatigue
- Being tested
- Walk With Ease
- Keywords
- Chemotherapy, Adjuvant Chemotherapy, Cancer Therapy, Fatigue, Physical Activity, Physical Function, Tiredness, Colon Cancer, Rectal Cancer, Walk With Ease, Colorectal Cancer, Geriatric Assessment, Geriatric, Elderly
- Medical subject headings
- Colorectal Neoplasms, Fatigue, Motor Activity, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk With EaseBehavioural
Also called WWE
A self-directed walking intervention developed by the Arthritis Foundation. The intervention is a workbook that coaches participants through walking regularly at a safe, comfortable pace with the ultimate goal of walking at least 30 minutes a day five days a week.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group will be receiving adjuvant chemotherapy for colorectal cancer. They will not participate in the Walk With Ease program. They will be followed up using standard of care. |
| Intervention | Experimental | This group will be receiving adjuvant chemotherapy for colorectal cancer. They will participate in the Walk With Ease (WWE) program during the course of their chemotherapy treatment. They will be requested to initiate the WWE starting on Day 1 of adjuvant chemotherapy. Participants are asked to walk at a safe and comfortable pace, increasing their minutes per day at a rate they can sustain, with the ultimate goal of 30 minutes/day for at least 5 days/week. They are asked to maintain a daily walking log that is provided to them, entering total minutes per day.
Participants will be asked to do the walking program independently (self-directed, not in a formal group with an instructor) throughout chemotherapy. Receives: Behavioral: Walk With Ease |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the change in fatigue after three months between the intervention and control arm
The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue.
Measured: Three Months
Secondary outcomes (9)
To measure changes in physical function at baseline between the intervention and control groups.
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
- Physical function as measured by PROMIS-PF and SPPB
Measured: 4 to 24 weeks
To measure adherence to the physical activity intervention
To report on the adherence of the physical activity intervention as measured through self-reported minutes of walking per days and walking minutes per week in the group randomized to the Intervention arm
Measured: One Year
To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups
The investigators will comparee the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups
Measured: One Year
To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms
The investigators will compare the change in p16INK4a and muscle mass measurements pre/post adjuvant chemotherapy between Intervention and Control groups
Measured: One Year
To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy
To explore the association of baseline measurements of p16INK4a and muscle mass with changes in fatigue, physical function, and health related quality of life during adjuvant chemotherapy.
Measured: Six months
To measure changes in Quality of Life at baseline between the intervention and control groups.
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
Quality of life as measured by FACT-FCSI and PROMIS-PI
Measured: 4 to 24 weeks
To measure changes in ADLs at baseline between the intervention and control groups.
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
ADLs per CGA
Measured: 4 to 24 weeks
To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups.
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
IADLs per CGA
Measured: 4 to 24 weeks
To measure changes in Self-Efficacy at baseline between the intervention and control groups.
To evaluate the following measures at baseline, 3 months, and after completion of chemotherapy and compare changes in these measures over time between Intervention and Control arms.
Self-efficacy and attitudes as measured by PSEFSM and OEE
Measured: 4 to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2014
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- LCCC Geriatric Oncology Program
- Responsible party
- Sponsor
- Investigators
- Hy Muss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191969
- Sponsor's protocol ID
- LCCC1324
- Status last verified
- Nov 2019
- First submitted
- 17 Jun 2014
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Williams GR, Nyrop KA, Deal AM, Muss HB, Sanoff HK. Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial. Contemp Clin Trials. 2015 May;42:90-7. doi: 10.1016/j.cct.2015.03.008. Epub 2015 Mar 28.
PubMed 25827253
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Physical Activity Intervention in Older Patients Undergoing Adjuvant Chemotherapy for Colorectal Cancer: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02191969
- Acronym / sponsor ID
- LCCC1324
- Conditions
- Colorectal Cancer, Fatigue
- Keywords
- Chemotherapy, Adjuvant Chemotherapy, Cancer Therapy, Fatigue, Physical Activity, Physical Function, Tiredness, Colon Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- LCCC Geriatric Oncology Program
- Study start
- Jun 2014
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will see if patient who undergo a physical activity intervention called Walk With Ease report experiencing less fatigue and a higher quality of life during chemotherapy for colorectal cancer than those who do not participate in this intervention.
Detailed description
The primary purpose of this multicenter, randomized controlled study is to evaluate the impact of a physical activity program on fatigue in older patients (≥60 years) undergoing adjuvant chemotherapy for colorectal cancer. The investigators also plan to evaluate physical function and quality of life as secondary objectives. The investigators' hypotheses are that people who undergo the physical activity intervention compared to those who do not, will: 1) report less fatigue, 2) report higher health related quality of life, and 3) have less decline in physical function. Additionally, The investigators will characterize ≥grade 3 adjuvant chemotherapy associated toxicities in this older population, and describe the changes reported in fatigue, physical function, and HRQOL over the course of chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group will be receiving adjuvant chemotherapy for colorectal cancer. They will not participate in the Walk With Ease program. They will be followed up using standard of care. |
| Intervention | Experimental | Behavioral: Walk With EaseThis group will be receiving adjuvant chemotherapy for colorectal cancer. They will participate in the Walk With Ease (WWE) program during the course of their chemotherapy treatment. They will be requested to initiate the WWE starting on Day 1 of adjuvant chemotherapy. Participants are asked to walk at a safe and comfortable pace, increasing their minutes per day at a rate they can sustain, with the ultimate goal of 30 minutes/day for at least 5 days/week. They are asked to maintain a daily walking log that is provided to them, entering total minutes per day. Participants will be asked to do the walking program independently (self-directed, not in a formal group with an instructor) throughout chemotherapy. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ Age 60 years (no upper age limit)
- Diagnosis of stage II-III colon or rectal cancer planned for treatment with adjuvant chemotherapy scheduled as part of standard treatment
- Able to read English (required for CGA and other surveys administered)
- Approval from their treating physician to engage in moderate-intensity physical activity
- Patient-assessed ability to walk and engage in moderate physical activity
Key exclusion criteria (4 listed)
- Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy
- Already walking or engaging in other physical activity >120 minutes per week as documented via subject self-report
- Unable to walk or engage in moderate-intensity physical activity
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk With EaseAlso: WWEA self-directed walking intervention developed by the Arthritis Foundation. The intervention is a workbook that coaches participants through walking regularly at a safe, comfortable pace with the ultimate goal of walking at least 30 minutes a day five days a week. | Behavioural | Intervention |
Primary outcome
To measure the change in fatigue after three months between the intervention and control arm
Time frame: Three Months
The investigators will compare the change in fatigue from baseline to 3 months between Intervention and Control arms as measured via PROMIS®-Fatigue.
9 secondary outcomes
To measure changes in physical function at baseline between the intervention and control groups.
Time frame: 4 to 24 weeks
To measure adherence to the physical activity intervention
Time frame: One Year
To measure the difference in p16INK4a levels before and after chemotherapy in the control and intervention groups
Time frame: One Year
To measure the change in muscle mass measurements before and after chemotherapy between the intervention and control arms
Time frame: One Year
To measure the association of p16INK4a and muscle mass with any differences in fatigue o physical function or QOL during chemotherapy
Time frame: Six months
To measure changes in Quality of Life at baseline between the intervention and control groups.
Time frame: 4 to 24 weeks
To measure changes in ADLs at baseline between the intervention and control groups.
Time frame: 4 to 24 weeks
To measure changes in Instrumental Activities of Daily Living at baseline between the intervention and control groups.
Time frame: 4 to 24 weeks
To measure changes in Self-Efficacy at baseline between the intervention and control groups.
Time frame: 4 to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Derived from this study: PubMed 25827253Williams GR, Nyrop KA, Deal AM, Muss HB, Sanoff HK. Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial. Contemp Clin Trials. 2015 May;42:90-7. doi: 10.1016/j.cct.2015.03.008. Epub 2015 Mar 28.
- The Geriatric Oncology Research Program at UNCLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hy Muss, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk With Ease in people with Colorectal Cancer and Fatigue, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 6 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 1 May 2020. 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 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.
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?
To measure the change in fatigue after three months between the intervention and control arm (time frame: Three Months). 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 NCT02191969, 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 1 May 2020.