CancerNCT00181129
Fatigue and Cancer Treatment(FACT)- an Exercise Intervention
A study testing home based self paced walking program in people with Cancer and Fatigue, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to determine the effects of a nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical functioning during adjuvant therapy for cancer. The sample will be randomized into exercise (EX) or usual care (UC) groups. Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- home based self paced walking program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to May 2008
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of cancer (Stage 1,2,or 3),
- 21 years of age or older,
- Free of cognitive or physical deficits that would preclude entry into study,
- not currently exercising 120 min/wk or more
Who cannot join
- Concurrent major health problems or disabilities that would limit participation in an exercise program.
- Stage 4 cancer (metastisis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: Mitigating Cancer Treatment-Related Fatigue by Exercise
The purpose of this randomized controlled trial is to determine the effects of a nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical functioning during adjuvant therapy for cancer. The sample will be randomized into exercise (EX) or usual care (UC) groups. The independent study variable is participation in a walking exercise program. Outcomes include: fatigue, sleep disturbance, emotional distress, physical functioning and quality of life. The effects of the walking exercise program will be evaluated using self-report questionnaires administered pre- and post-treatment, patient diaries, and symptoms assessments at defined intervals during adjuvant therapy
- Being tested
- home based self paced walking program
- Keywords
- Fatigue, Cancer treatment
- Medical subject headings
- Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home based self paced walking programBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionMay 2008
- Study completionMay 2008
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 Johns Hopkins UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria L Mock, DNSc, Principal investigator, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181129
- Sponsor's protocol ID
- NINR:RO1NRO4991
- Status last verified
- Dec 2018
- First submitted
- 12 Sep 2005
- Last updated
- 20 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Cancer Treatment-Related Fatigue by Exercise
- ClinicalTrials.gov ID
- NCT00181129
- Acronym / sponsor ID
- NINR:RO1NRO4991
- Keywords
- Fatigue, Cancer treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2002 (actual)
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 16 Sep 2005 (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 purpose of this randomized controlled trial is to determine the effects of a nurse-directed, home-based walking exercise program to mitigate fatigue and maintain physical functioning during adjuvant therapy for cancer. The sample will be randomized into exercise (EX) or usual care (UC) groups. The independent study variable is participation in a walking exercise program. Outcomes include: fatigue, sleep disturbance, emotional distress, physical functioning and quality of life. The effects of the walking exercise program will be evaluated using self-report questionnaires administered pre- and post-treatment, patient diaries, and symptoms assessments at defined intervals during adjuvant therapy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of cancer (Stage 1,2,or 3),
- 21 years of age or older,
- Free of cognitive or physical deficits that would preclude entry into study,
- not currently exercising 120 min/wk or more
Key exclusion criteria (2 listed)
- Concurrent major health problems or disabilities that would limit participation in an exercise program.
- Stage 4 cancer (metastisis)
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 |
|---|---|---|
| home based self paced walking program | Behavioural | – |
Primary outcome
Not reported in the source record.
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 Dec 2018.
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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.
Victoria L Mock, DNSc principal investigator
Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home based self paced walking program in people with Cancer and Fatigue, run by Johns Hopkins University 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 4 inclusion and 2 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 Dec 2018. 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.
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 Dec 2018.