Breast CancerPhase 2WWENCT02434367
The Effect of Walking on Fatigue During Radiotherapy in Breast Cancer Patients 65 and Older
A Phase 2 study testing Walk With Ease Arm A in people with Breast Cancer and Fatigue, run by The West Clinic, Memphis at 2 sites in United States.
Trial summary
This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer, Fatigue
- What is being tested?
- Walk With Ease Arm A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to 30 Jun 2017
- Phase
- Phase 2
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- ≥65 years of age
- Histologically confirmed Stage I, II or III breast cancer status post breast surgery with or without adjuvant chemotherapy.
- Scheduled to undergo hypofractionated or standard fractionated radiation therapy to the breast or chest wall.
- English speaking.
- IRB approved, signed written informed consent.
- Approval from their treating radiation oncologist to engage in moderate-intensity physical activity. This will be obtained by the study research coordinator and documented on the study screening form (attached).
- 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.
- Receiving accelerated partial breast irradiation.
- Unable to walk or engage in moderate-intensity physical activity.
- Already participated in Walk with Ease Program.
- Already actively walking (≥120 minutes per week).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
The West Clinic/ University of Tennesee West Cancer Center
Memphis, Tennessee, 38120
About this study
Official title: Phase 2 Randomized Study of a Walking Intervention for Radiation-related Fatigue Among Breast Cancer Patients Receiving Adjuvant Radiation
This multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery.
Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women in both arms will complete a number of surveys including questionnaires on fatigue, pain, depression, sleep, and social support. In addition, a blood sample will be collected prior to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of inflammatory biomarkers, and their potential association with exercise and fatigue.
Read the detailed description
Recruitment, consent, and randomization will occur at first postoperative visit with a radiation oncologist. A 1:1 randomization will occur between WWE program and usual care (scripted discussion on benefit of exercise during radiotherapy). Prior to initiation of radiation, women in both arms will complete 68 questions from questionnaires on pain, depression, sleep, and social support. In addition, peripheral blood will be drawn for analysis of pre-radiation measures of inflammatory biomarkers. Women randomized to the WWE program will also receive a daily walking log that they will be asked to fill out and return on the last week of radiation (6 weeks for standard fractionation and 4.5 weeks for hypofractionation), and at 4-6 weeks post radiotherapy. Also, on their last week of radiotherapy and 4-6 weeks after radiotherapy all patients will repeat the questionnaires and a blood draw for measures of inflammatory biomarkers.
Contact with study participants will be at 3 points in time after enrollment and randomization:
Baseline: At this meeting, requirements of the study will be reviewed, and study materials provided (for control arm: a one page explanation discussing the potential benefits of exercise on fatigue, for experimental arm: WWE workbook, and printed walking log). Participants will complete questionnaires and undergo other assessments including a blood draw. For those on the experimental arm, they will be asked to begin the walking program within a week, noting their walking experience in their daily log.
Last week of radiation: All participants will repeat questionnaires and other assessments during any day of their last week of radiation. A repeat blood draw will be taken. In addition those on the WWE arm will have their walking log reviewed. For those receiving hypofractionated radiotherapy, this will occur at week 4. For those receiving standard fractionation this will occur at week 6.
4-6 weeks following end of radiation: All participants will repeat questionnaires and other assessments. A repeat blood draw will be taken. In addition those on the WWE arm will have their walking log reviewed.
Patients randomized to the usual care arm will receive a document with information on exercise to improve fatigue during radiotherapy. The sheet will summarize the findings of the 3 randomized studies on exercise intervention during radiotherapy.
The primary activity required of study subjects is a 4-6-week self-directed (non-group) WWE walking program that participants do at a place and time that is convenient for them. 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.
- Conditions
- Breast Cancer, Fatigue
- Being tested
- Walk With Ease Arm A
- Keywords
- Cancer
- Medical subject headings
- Breast Neoplasms, Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk With Ease Arm ABehavioural
Also called WWE
Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The interention is a self directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes per day, five days per week.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Women randomized to the WWE program will receive a workbook, and a daily walking log, the latter to be completed during the study. Receives: Behavioral: Walk With Ease Arm A |
| Arm B | No intervention | Patients randomized to the usual care arm will receive a document with information on exercise to improve fatigue during radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the change in treatment related fatigue from baseline to last week of radiotherapy between patients in the WWE intervention and usual care arms using the Fatigue Symptom Index (FSI).
change in fatigue index
Measured: Four months
Secondary outcomes (3)
Compare the change in treatment related fatigue from baseline to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms using the FSI.
change in fatigue index
Measured: Four months
Change in Treatment Related Fatigue Symptom Index
Compare the change in treatment related fatigue from baseline to last week of radiotherapy and to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms using the PROMIS Fatigue 8a scale.
Measured: Four months
Change in Physical Funcionality Index
Compare the change in physical functionality from baseline to last week of radiotherapy and to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms using the Short Physical Performance Battery and PROMIS Short Form v1.0
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startAug 2014
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The West Clinic, Memphis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Tennessee West Cancer Center
- Responsible party
- Sponsor
- Investigators
- Noam VanderWalde, MD, Principal investigator, The West Clinic/University of Tennessee West Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434367
- Sponsor's protocol ID
- LCCC 1412
- Acronym
- WWE
- Status last verified
- Nov 2016
- First submitted
- 20 Apr 2015
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Study of a Walking Intervention for Radiation-related Fatigue Among Breast Cancer Patients Receiving Adjuvant Radiation
- ClinicalTrials.gov ID
- NCT02434367
- Acronym / sponsor ID
- WWE / LCCC 1412
- Conditions
- Breast Cancer, Fatigue
- Keywords
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The West Clinic, MemphisIndustry (pharma, biotech, devices)
- Collaborators
- University of Tennessee West Cancer Center
- Study start
- Aug 2014 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 May 2015 (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 multicenter randomized (1:1) phase 2 study is designed to assess the efficacy of the Walk with Ease exercise program on improving fatigue after adjuvant radiotherapy compared to usual care in 50 women with stage 0-3 breast cancer who have undergone breast surgery.
Prior to initiation of radiation, during the last week, and 4-6 weeks post radiation, women in both arms will complete a number of surveys including questionnaires on fatigue, pain, depression, sleep, and social support. In addition, a blood sample will be collected prior to, during the last week of radiation, and 4-6 weeks post radiation to explore measures of inflammatory biomarkers, and their potential association with exercise and fatigue.
Detailed description
Recruitment, consent, and randomization will occur at first postoperative visit with a radiation oncologist. A 1:1 randomization will occur between WWE program and usual care (scripted discussion on benefit of exercise during radiotherapy). Prior to initiation of radiation, women in both arms will complete 68 questions from questionnaires on pain, depression, sleep, and social support. In addition, peripheral blood will be drawn for analysis of pre-radiation measures of inflammatory biomarkers. Women randomized to the WWE program will also receive a daily walking log that they will be asked to fill out and return on the last week of radiation (6 weeks for standard fractionation and 4.5 weeks for hypofractionation), and at 4-6 weeks post radiotherapy. Also, on their last week of radiotherapy and 4-6 weeks after radiotherapy all patients will repeat the questionnaires and a blood draw for measures of inflammatory biomarkers.
Contact with study participants will be at 3 points in time after enrollment and randomization:
Baseline: At this meeting, requirements of the study will be reviewed, and study materials provided (for control arm: a one page explanation discussing the potential benefits of exercise on fatigue, for experimental arm: WWE workbook, and printed walking log). Participants will complete questionnaires and undergo other assessments including a blood draw. For those on the experimental arm, they will be asked to begin the walking program within a week, noting their walking experience in their daily log.
Last week of radiation: All participants will repeat questionnaires and other assessments during any day of their last week of radiation. A repeat blood draw will be taken. In addition those on the WWE arm will have their walking log reviewed. For those receiving hypofractionated radiotherapy, this will occur at week 4. For those receiving standard fractionation this will occur at week 6.
4-6 weeks following end of radiation: All participants will repeat questionnaires and other assessments. A repeat blood draw will be taken. In addition those on the WWE arm will have their walking log reviewed.
Patients randomized to the usual care arm will receive a document with information on exercise to improve fatigue during radiotherapy. The sheet will summarize the findings of the 3 randomized studies on exercise intervention during radiotherapy.
The primary activity required of study subjects is a 4-6-week self-directed (non-group) WWE walking program that participants do at a place and time that is convenient for them. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Behavioral: Walk With Ease Arm AWomen randomized to the WWE program will receive a workbook, and a daily walking log, the latter to be completed during the study. |
| Arm B | No intervention | –Patients randomized to the usual care arm will receive a document with information on exercise to improve fatigue during radiotherapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- ≥65 years of age
- Histologically confirmed Stage I, II or III breast cancer status post breast surgery with or without adjuvant chemotherapy.
- Scheduled to undergo hypofractionated or standard fractionated radiation therapy to the breast or chest wall.
- English speaking.
- IRB approved, signed written informed consent.
Key exclusion criteria (5 listed)
- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.
- Receiving accelerated partial breast irradiation.
- Unable to walk or engage in moderate-intensity physical activity.
- Already participated in Walk with Ease Program.
- Already actively walking (≥120 minutes per week).
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 Arm AAlso: WWEWalk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The interention is a self directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes per day, five days per week. | Behavioural | Arm A |
Primary outcome
Compare the change in treatment related fatigue from baseline to last week of radiotherapy between patients in the WWE intervention and usual care arms using the Fatigue Symptom Index (FSI).
Time frame: Four months
change in fatigue index
3 secondary outcomes
Compare the change in treatment related fatigue from baseline to 1-4 months post-radiotherapy between patients in the WWE intervention and usual care arms using the FSI.
Time frame: Four months
Change in Treatment Related Fatigue Symptom Index
Time frame: Four months
Change in Physical Funcionality Index
Time frame: Four months
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 14 Dec 2017.
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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.
Noam VanderWalde, MD principal investigator
The West Clinic/University of Tennessee West Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Walk With Ease Arm A in people with Breast Cancer and Fatigue, run by The West Clinic, Memphis at 2 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 7 inclusion and 5 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 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Compare the change in treatment related fatigue from baseline to last week of radiotherapy between patients in the WWE intervention and usual care arms using the Fatigue Symptom Index (FSI). (time frame: Four months). 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 14 Dec 2017.