CancerPhase 1CanWellNCT00798200
Community Based Exercise Program for Well Cancer Survivors
A Phase 1 study testing Exercise program in people with Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
This project will create a community based exercise program for well cancer survivors. The goal is that the YMCA will gain the competence to work with this unique population in a safe and productive manner. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Jan 2016
- Phase
- Phase 1
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All well cancer survivors who are medically stable.
Who cannot join
- Children are not eligible for this project.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CanWell: YMCA Based Exercise Program for Well Cancer Survivors
This project will create a community based exercise program for well cancer survivors. The goal is that the YMCA will gain the competence to work with this unique population in a safe and productive manner.
Read the detailed description
All well, adult, cancer survivors are eligible to participate.
- Conditions
- Cancer
- Being tested
- Exercise program
- Keywords
- Cancer, Oncology, Rehabilitation, Endurance, Strength
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
All exercise programs will include endurance and strength exercises.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | All participants will take part in a supervised, structured, exercise program Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance measure (STEEP treadmill test)
Measured: Within one week before initiating the exercise program
Endurance measure (STEEP treadmill test)
Measured: Administered at 6 weeks of the exercise program
Endurance measure (STEEP treadmill test)
Measured: Administered at 12 weeks (end of) the exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startMar 2009
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Oren Cheifetz, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798200
- Sponsor's protocol ID
- WorkForceOntario 001
- Acronym
- CanWell
- Status last verified
- Mar 2016
- First submitted
- 25 Nov 2008
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheifetz O, Dorsay JP, MacDermid JC. Exercise facilitators and barriers following participation in a community-based exercise and education program for cancer survivors. J Exerc Rehabil. 2015 Feb 28;11(1):20-9. doi: 10.12965/jer.150183. eCollection 2015 Feb.
PubMed 25830140Cheifetz O, Park Dorsay J, Hladysh G, Macdermid J, Serediuk F, Woodhouse LJ. CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. Psychooncology. 2014 Feb;23(2):204-15. doi: 10.1002/pon.3389. Epub 2013 Sep 6.
PubMed 24009181
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CanWell: YMCA Based Exercise Program for Well Cancer Survivors
- ClinicalTrials.gov ID
- NCT00798200
- Acronym / sponsor ID
- CanWell / WorkForceOntario 001
- Conditions
- Cancer
- Keywords
- Cancer, Oncology, Rehabilitation, Endurance, Strength
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Mar 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Nov 2008 (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 project will create a community based exercise program for well cancer survivors. The goal is that the YMCA will gain the competence to work with this unique population in a safe and productive manner.
Detailed description
All well, adult, cancer survivors are eligible to participate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Other: Exercise programAll participants will take part in a supervised, structured, exercise program |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All well cancer survivors who are medically stable.
Key exclusion criteria (1 listed)
- Children are not eligible for this project.
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 |
|---|---|---|
| Exercise programAll exercise programs will include endurance and strength exercises. | Other | Exercise |
Primary outcome
Endurance measure (STEEP treadmill test)
Time frame: Within one week before initiating the exercise program
Endurance measure (STEEP treadmill test)
Time frame: Administered at 6 weeks of the exercise program
Endurance measure (STEEP treadmill test)
Time frame: Administered at 12 weeks (end of) the exercise program
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 3 Mar 2016.
- Results publication: PubMed 25830140Cheifetz O, Dorsay JP, MacDermid JC. Exercise facilitators and barriers following participation in a community-based exercise and education program for cancer survivors. J Exerc Rehabil. 2015 Feb 28;11(1):20-9. doi: 10.12965/jer.150183. eCollection 2015 Feb.
- Results publication: PubMed 24009181Cheifetz O, Park Dorsay J, Hladysh G, Macdermid J, Serediuk F, Woodhouse LJ. CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. Psychooncology. 2014 Feb;23(2):204-15. doi: 10.1002/pon.3389. Epub 2013 Sep 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise program in people with Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 1 inclusion and 1 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 3 Mar 2016. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Endurance measure (STEEP treadmill test) (time frame: Within one week before initiating the exercise program). The study lists 3 primary outcomes in all. 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 NCT00798200, which also lists 2 linked publications.
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 3 Mar 2016.