CancerPhase 1NCT01883635
Exercise Intervention for Cancer Survivors and Caregivers
A Phase 1 study testing Survivor-only progressive walking and resistance exercise and Dyadic progressive walking and resistance exercise in people with Cancer, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Survivor-only progressive walking and resistance exercise and Dyadic progressive walking and resistance exercise
- 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
- May 2013to Aug 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months.
- Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments
- Have a caregiver willing to participate int he study
- Be able to read English
- Be 21 years of age or older
- Give written informed consent
Show all 10Show fewer
- Be nominated by a cancer survivor
- Be able to read English
- Be 21 years of age or older
- Give written informed consent
Who cannot join
- have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor.
- For caregivers, be currently undergoing active treatment for cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dyadic Exercise Intervention for Cancer Survivors and Caregivers
The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.
Read the detailed description
This was a pilot feasibility study to refine our methodology before a larger Phase II trial.
- Conditions
- Cancer
- Being tested
- Survivor-only progressive walking and resistance exercise, Dyadic progressive walking and resistance exercise
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivor-only progressive walking and resistance exerciseBehavioural
Also called EXCAP
Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only
Dyadic progressive walking and resistance exerciseBehavioural
Also called EXCAP-PA
Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad
| Study group | Role | What they receive |
|---|---|---|
| Individual Exercise Intervention | Active comparator | Survivor-only progressive walking and resistance exercise Receives: Behavioral: Survivor-only progressive walking and resistance exercise |
| Dyadic Exercise Intervention | Experimental | Dyadic progressive walking and resistance exercise Receives: Behavioral: Dyadic progressive walking and resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Distress
Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.
Measured: Baseline to post-intervention (6 weeks later)
Secondary outcomes (1)
Immune Biomarkers
We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.
Measured: Baseline to post-intervention (6 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Kamen, University of Rochester
- Investigators
- Charles Kamen, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883635
- Sponsor's protocol ID
- 46413
- Status last verified
- Jan 2016
- First submitted
- 5 Jun 2013
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic Exercise Intervention for Cancer Survivors and Caregivers
- ClinicalTrials.gov ID
- NCT01883635
- Acronym / sponsor ID
- 46413
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Posted 30 Nov 2015
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 the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.
Detailed description
This was a pilot feasibility study to refine our methodology before a larger Phase II trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Exercise Intervention | Active comparator | Behavioral: Survivor-only progressive walking and resistance exerciseSurvivor-only progressive walking and resistance exercise |
| Dyadic Exercise Intervention | Experimental | Behavioral: Dyadic progressive walking and resistance exerciseDyadic progressive walking and resistance exercise |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months.
- Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments
- Have a caregiver willing to participate int he study
- Be able to read English
- Be 21 years of age or older
Key exclusion criteria (2 listed)
- have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor.
- For caregivers, be currently undergoing active treatment for cancer
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 |
|---|---|---|
| Survivor-only progressive walking and resistance exerciseAlso: EXCAPDaily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only | Behavioural | Individual Exercise Intervention |
| Dyadic progressive walking and resistance exerciseAlso: EXCAP-PADaily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad | Behavioural | Dyadic Exercise Intervention |
Primary outcome
Psychological Distress
Time frame: Baseline to post-intervention (6 weeks later)
Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.
1 secondary outcome
Immune Biomarkers
Time frame: Baseline to post-intervention (6 weeks later)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Charles Kamen, PhD principal investigator
University of Rochester
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 Survivor-only progressive walking and resistance exercise and Dyadic progressive walking and resistance exercise in people with Cancer, run by University of Rochester 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 10 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 5 Feb 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 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 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?
Yes. Results are posted in the registry (first posted 30 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Psychological Distress (time frame: Baseline to post-intervention (6 weeks later)). 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 5 Feb 2016.