Breast CancerWWENCT01789983
Feasibility of an Evidence-based Walking Program in Cancer Pts 60+ During Chemotherapy
An observational study of Breast Cancer and Colon Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Breast Cancer, Colon Cancer, Lung Cancer
- What is being tested?
- Walk With Ease Program and Collect Blood, GA and Other Survey Tools
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2021
- Phase
- Observational
- 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
Study population: Colon, lung and breast cancer patients age 60 and above who are beginning chemotherapy or chemoradiation treatment.
Who may be able to join
- ≥60 years of age, male or female
- Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer diagnosis, then the most recent diagnosis); Stage I, II or III lung cancer, or Stage II or III colon cancer
- Scheduled to begin a chemotherapy (or concomitant chemoradiotherapy) regimen that will last at least 6 weeks in duration
- English speaking
- IRB approved, signed written informed consent
- Approval from their treating physician to engage in moderate-intensity physical activity
- Patient-assessed ability to walk and engage in moderate physical activity
- Willing and able to meet all study requirements.
Who cannot join
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
- Cancer surgery scheduled within the study period
- Unable to walk or engage in moderate-intensity physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Cancer Hospital
Chapel Hill, North Carolina, 27514
About this study
Official title: Feasibility of an Evidence-based Walking Program in a Sample of Cancer Patients >60 Years of Age Undergoing Cytotoxic Chemotherapy
The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program.
Read the detailed description
The primary purpose of this study is to evaluate the feasibility of implementing a moderate-intensity walking program (Walk With Ease/WWE) among cancer patients, age ≥60 years, as they undergo cytotoxic chemotherapy treatment. Feasibility will be determined based on the rate of participation in the WWE program. As secondary objectives, we will also establish the rate of completion of a number of instruments, including a Geriatric Assessment tool, and other instruments that measure self-reported quality of life (e.g., fatigue, depression, and pain), and self-reported physical activity (PA). Data from these instruments, as well as from serial measurements of a biomarker of aging (p16INK4a) will be explored and used to inform future studies designed to evaluate any relationship between these variables and participation in the WWE program.
We propose a sample (n=30) of cancer patients ≥60 years of age with potentially curable cancer and a diagnosis of Stage I-III breast cancer, Stage I-III lung cancer, or Stage II-III colon cancer, who are about to begin chemotherapy. Participation will be defined as completing the 6-week WWE program. Results from this study will be used in an RO1 application to the National Cancer Institute (NCI) pertaining to PA interventions among cancer patients and the effects of biomarkers on prognosis and survival.
- Conditions
- Breast Cancer, Colon Cancer, Lung Cancer
- Being tested
- Walk With Ease Program, Collect Blood, GA and Other Survey Tools
- Keywords
- Physical Activity, Chemotherapy, Elderly, Geriatric, Walking, Geriatric Assessment, Geriatric Oncology
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk With Ease ProgramBehavioural
Also called WWE
The primary activity required of study subjects is a 6-week self-directed (non-group) WWE walking program that study participants do at a place and time that is convenient for them. To start the intervention/program, we schedule a brief baseline meeting with study participants to discuss the program, provide the WWE workbook, secure printed informed consent, and complete various questionnaires. Study participants are also asked to maintain a daily walking diary that is provided to them.
The WWE program includes a workbook with strengthening and stretching exercises, basic facts about arthritis and PA, and information on how to individualize the program.
Collect Blood, GA and Other Survey ToolsOther
- Geriatric Assessment (GA) (Version 5)
- Functional Assessment of Cancer Therapy-General (FACT)
- Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue36
- Outcome Expectations for Exercise (OEE) scale29
- Self-Efficacy to Manage Arthritis or Joint Pain (ASE/Arthritis Self-Efficacy)
- Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)34,35
- Visual Analog Scales (VAS)
Surveys included in study are listed above. Whole Blood Sample will be collected for p16 analysis.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients 60+ | Breast Cancer Patients age 60 and older who have histologically confirmed stage I, II or III disease. Receives: Behavioral: Walk With Ease Program; Other: Collect Blood, GA and Other Survey Tools | |
| Lung Cancer Patients 60+ | Lung Cancer Patients age 60 and above who have stage I, II or III disease Receives: Behavioral: Walk With Ease Program; Other: Collect Blood, GA and Other Survey Tools | |
| Colon Cancer Patients 60+ | Colon cancer patients age 60 and above who have stage II or III disease. Receives: Behavioral: Walk With Ease Program; Other: Collect Blood, GA and Other Survey Tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the feasibility of implementing the WWE program among cancer patients, age ≥60, as they undergo cytotoxic chemotherapy treatment.
Feasibility will be defined as the proportion of recruited subjects who complete the 6-week WWE program.
Measured: 1 year
Secondary outcomes (2)
To measure the rate of completion of each of the following questionnaires/assessments at 3 different time points
The rate of completion of assessments will be measured at baseline, 6 weeks and end of chemotherapy treatment.
Measured: 1 year
To measure relationships between physical activity levels and p16 levels.
To measure the association between number of minutes walked per day and number of times per week with p16 levels.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, University of North Carolina Lineberger Comprehensive Cancer CenterKirsten A Nyrop, PhD, Principal investigator, University of North Carolina Thurston Arthritis Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789983
- Sponsor's protocol ID
- LCCC1226
- Other IDs
- 12-1975
- Acronym
- WWE
- Status last verified
- Mar 2024
- First submitted
- 8 Feb 2013
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Evidence-based Walking Program in a Sample of Cancer Patients >60 Years of Age Undergoing Cytotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT01789983
- Acronym / sponsor ID
- WWE / LCCC1226
- Conditions
- Breast Cancer, Colon Cancer, Lung Cancer
- Keywords
- Physical Activity, Chemotherapy, Elderly, Geriatric, Walking, Geriatric Assessment, Geriatric Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 12 Feb 2013 (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.
The study will look at conducting a medium-intense walking program called Walk With Ease with cancer patients age 60 and above who are starting chemotherapy treatment. We will measure how many of these patients complete their participation in this program.
Detailed description
The primary purpose of this study is to evaluate the feasibility of implementing a moderate-intensity walking program (Walk With Ease/WWE) among cancer patients, age ≥60 years, as they undergo cytotoxic chemotherapy treatment. Feasibility will be determined based on the rate of participation in the WWE program. As secondary objectives, we will also establish the rate of completion of a number of instruments, including a Geriatric Assessment tool, and other instruments that measure self-reported quality of life (e.g., fatigue, depression, and pain), and self-reported physical activity (PA). Data from these instruments, as well as from serial measurements of a biomarker of aging (p16INK4a) will be explored and used to inform future studies designed to evaluate any relationship between these variables and participation in the WWE program.
We propose a sample (n=30) of cancer patients ≥60 years of age with potentially curable cancer and a diagnosis of Stage I-III breast cancer, Stage I-III lung cancer, or Stage II-III colon cancer, who are about to begin chemotherapy. Participation will be defined as completing the 6-week WWE program. Results from this study will be used in an RO1 application to the National Cancer Institute (NCI) pertaining to PA interventions among cancer patients and the effects of biomarkers on prognosis and survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients 60+ | – | Behavioral: Walk With Ease Program, Other: Collect Blood, GA and Other Survey ToolsBreast Cancer Patients age 60 and older who have histologically confirmed stage I, II or III disease. |
| Lung Cancer Patients 60+ | – | Behavioral: Walk With Ease Program, Other: Collect Blood, GA and Other Survey ToolsLung Cancer Patients age 60 and above who have stage I, II or III disease |
| Colon Cancer Patients 60+ | – | Behavioral: Walk With Ease Program, Other: Collect Blood, GA and Other Survey ToolsColon cancer patients age 60 and above who have stage II or III disease. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colon, lung and breast cancer patients age 60 and above who are beginning chemotherapy or chemoradiation treatment.
Key inclusion criteria (8 listed)
- ≥60 years of age, male or female
- Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer diagnosis, then the most recent diagnosis); Stage I, II or III lung cancer, or Stage II or III colon cancer
- Scheduled to begin a chemotherapy (or concomitant chemoradiotherapy) regimen that will last at least 6 weeks in duration
- English speaking
- IRB approved, signed written informed consent
Key exclusion criteria (3 listed)
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention
- Cancer surgery scheduled within the study period
- Unable to walk or engage in moderate-intensity physical activity
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 Ease ProgramAlso: WWEThe primary activity required of study subjects is a 6-week self-directed (non-group) WWE walking program that study participants do at a place and time that is convenient for them. To start the intervention/program, we schedule a brief baseline meeting with study participants to discuss the program, provide the WWE workbook, secure printed informed consent, and complete various questionnaires. Study participants are also asked to maintain a daily walking diary that is provided to them. The WWE program includes a workbook with strengthening and stretching exercises, basic facts about arthritis and PA, and information on how to individualize the program. | Behavioural | Breast Cancer Patients 60+, Colon Cancer Patients 60+, Lung Cancer Patients 60+ |
| Collect Blood, GA and Other Survey Tools* Geriatric Assessment (GA) (Version 5) * Functional Assessment of Cancer Therapy-General (FACT) * Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue36 * Outcome Expectations for Exercise (OEE) scale29 * Self-Efficacy to Manage Arthritis or Joint Pain (ASE/Arthritis Self-Efficacy) * Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)34,35 * Visual Analog Scales (VAS) Surveys included in study are listed above. Whole Blood Sample will be collected for p16 analysis. | Other | Breast Cancer Patients 60+, Colon Cancer Patients 60+, Lung Cancer Patients 60+ |
Primary outcome
To measure the feasibility of implementing the WWE program among cancer patients, age ≥60, as they undergo cytotoxic chemotherapy treatment.
Time frame: 1 year
Feasibility will be defined as the proportion of recruited subjects who complete the 6-week WWE program.
2 secondary outcomes
To measure the rate of completion of each of the following questionnaires/assessments at 3 different time points
Time frame: 1 year
To measure relationships between physical activity levels and p16 levels.
Time frame: 1 year
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 20 Mar 2024.
- 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.
Hyman Muss, MD principal investigator
University of North Carolina Lineberger Comprehensive Cancer Center
Kirsten A Nyrop, PhD principal investigator
University of North Carolina Thurston Arthritis Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colon Cancer, 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 8 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: 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 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 feasibility of implementing the WWE program among cancer patients, age ≥60, as they undergo cytotoxic chemotherapy treatment. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.