CancerS-PACTNCT02191982
The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older
A study testing Walk With Ease in people with Cancer and Geriatric, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue. Read more about this study
- Who is it for?
- Ages 65 years and older
- 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
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women age 65 years and older
- Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD
- Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)
- Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)
- Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer
- Moderate to severe fatigue (>4 on BFI)
Show all 12Show fewer
- Less than 120 minutes/week of physical activity
- English speaking
- Signed IRB approved 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
- Receiving hormonal therapy for prostate cancer
- Unable to walk or engage in moderate-intensity physical activity
- Have BFI≤3.
- Report more than 120 minutes/week of physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)
This study will look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.
Read the detailed description
The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.
- Being tested
- Walk With Ease
- Keywords
- Cancer, Chemotherapy, Fatigue, Elderly, Geriatric, Any Cancer, Cancer Treatment, Weakness, Tiredness
- Medical subject headings
- Neoplasms, Fatigue, Asthenia
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
Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention 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 a day, five days a week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm will begin the Walk With Ease program after the completion of chemotherapy. Receives: Behavioral: Walk With Ease |
| Wait List Control | Active comparator | The arm will begin the Walk With Ease program three months after completion of 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 change in fatigue scores between intervention and wait list control arms from baseline to three months.
Change in fatigue will be measured using the FACIT-F.
Measured: Three months
Secondary outcomes (9)
To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
This outcome will be measured by the Brief Fatigue Inventory
Measured: Three months
To report recruitment and retention in the study at 3 months
Measured: Three months
To report recruitment and retention in the study at 6 months
Measured: Six months
To measure implementation of and adherence to WWE
Measured: Six months
To count the number of adverse events
To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.
Measured: Six months
To measure change in engagement of walking over time from baseline to three months.
To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.
Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
Measured: Three Months
To measure change in physical function over time from baseline to three months.
To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.
Physical function as measured by SPPB
Measured: Three Months
To measure change in quality of life over time from baseline to three months.
To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.
Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression.
Measured: Three Months
To measure change in self-efficacy over time from baseline to three months.
To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms.
Engagement in walking (total minutes per week) as measured by engagement in physical activity questions
Measured: Three Months
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 completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Hyman B Muss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191982
- Sponsor's protocol ID
- LCCC1402
- Acronym
- S-PACT
- Status last verified
- Sep 2017
- First submitted
- 20 Jun 2014
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)
- ClinicalTrials.gov ID
- NCT02191982
- Acronym / sponsor ID
- S-PACT / LCCC1402
- Keywords
- Cancer, Chemotherapy, Fatigue, Elderly, Geriatric, Any Cancer, Cancer Treatment, Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- Jun 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (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 look at the impact of a self-directed walking program on post-chemotherapy survivors experiencing fatigue. It is hypothesized that the walking program will help lessen fatigue.
Detailed description
The investiagors propose to evaluate the impact of a home-based self-directed walking program on post-chemotherapy fatigue among 150 cancer survivors age 65 and older -- Senior Physical Activity after Chemotherapy (S-PACT). Participants must have potentially curable cancer, moderate to severe fatigue (score of 4 or higher on the Brief Fatigue Inventory), currently exercise less than 120 minutes per week and have completed chemotherapy treatment (radiation treatment must also be completed if it is part of the patient's treatment plan) within the last 6 weeks. The design is a randomized controlled trial, with participants randomized to a 3-month physical activity program (intervention group) or to wait-list control (this group begins the walking program at 3 months post-randomization). The primary objective is to compare the change in fatigue scores from baseline to 3 months between the intervention and wait-list control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Walk With EaseThis arm will begin the Walk With Ease program after the completion of chemotherapy. |
| Wait List Control | Active comparator | Behavioral: Walk With EaseThe arm will begin the Walk With Ease program three months after completion of chemotherapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Men and women age 65 years and older
- Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD
- Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)
- Moderate to severe fatigue (>4 on BFI)
- Less than 120 minutes/week of physical activity
Key exclusion criteria (4 listed)
- Receiving hormonal therapy for prostate cancer
- Unable to walk or engage in moderate-intensity physical activity
- Have BFI≤3.
- Report more than 120 minutes/week of 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 EaseAlso: WWEWalk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention 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 a day, five days a week. | Behavioural | Intervention, Wait List Control |
Primary outcome
To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
Time frame: Three months
Change in fatigue will be measured using the FACIT-F.
9 secondary outcomes
To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
Time frame: Three months
To report recruitment and retention in the study at 3 months
Time frame: Three months
To report recruitment and retention in the study at 6 months
Time frame: Six months
To measure implementation of and adherence to WWE
Time frame: Six months
To count the number of adverse events
Time frame: Six months
To measure change in engagement of walking over time from baseline to three months.
Time frame: Three Months
To measure change in physical function over time from baseline to three months.
Time frame: Three Months
To measure change in quality of life over time from baseline to three months.
Time frame: Three Months
To measure change in self-efficacy over time from baseline to three months.
Time frame: Three 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 12 Sep 2017.
- UNC Geriatric Oncology ProgramLink 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 B 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 Cancer and Geriatric, 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 12 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 12 Sep 2017. 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 change in fatigue scores between intervention and wait list control arms from baseline to three months. (time frame: Three 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 12 Sep 2017.