CancerNCT00791375
Web-based Physical Activity Intervention for Young Adult Cancer Survivors
A study testing Physical activity intervention in people with Cancer, run by The Miriam Hospital at 1 site in United States.
Trial summary
The goal of this study is to adapt a previously developed web-based physical activity intervention so that the intervention targets young adult cancer survivors(age 18 to 39). The web-based intervention will then be pilot tested to determine whether it is feasible for and acceptable to young adult cancer survivors; we… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Apr 2011
- 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 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18 to 39
- diagnosed with any form of cancer (except non-melanoma skin cancer) between the ages of 18 and 39 in the past 10 years
- completed all surgery, chemotherapy and radiation therapy
- currently in a cancer remission
- able to speak and write fluently in English
- able to access the Internet (at home, school, or work)
- sedentary.
Who cannot join
- currently pregnant or the intention to get pregnant
- the presence of a known medical condition (e.g., history of CVD) or history of severe psychiatric illness (e.g., psychotic disorder) making participation dangerous or very difficult
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to adapt a previously developed web-based physical activity intervention so that the intervention targets young adult cancer survivors(age 18 to 39). The web-based intervention will then be pilot tested to determine whether it is feasible for and acceptable to young adult cancer survivors; we hypothesize that the intervention will be both feasible and acceptable. Preliminary data on the effects of the intervention on physical activity level, mood and fatigue will also be collected.
Read the detailed description
Young adults diagnosed with cancer constitute a particularly vulnerable population whose medical and psychosocial needs are often overlooked. Those diagnosed with cancer between the ages of 18 and 39 face a number of increased risks including an increased risk of cardiovascular disease, second cancers, and emotional distress. Despite this, only a very small percentage of cancer research has focused on the survivorship issues of young adults. The goal of the proposed research is to address some of the unmet needs among young adult cancer survivors by developing and pilot testing a physical activity intervention for this population. Physical activity was selected as the target behavior as: 1. a high percentage of young adult cancer survivors have a sedentary lifestyle and 2. research has shown that cancer survivors who increase their physical activity experience improved cardiopulmonary function, reduced fatigue, enhanced mood and superior cancer outcomes. The intervention will be based on a previously developed, theoretically-grounded, tailored Internet intervention for sedentary adults. This previously developed intervention uses components of the Transtheoretical Model and Social Cognitive Theory to promote physical activity; for example, participants complete monthly questionnaires online and received tailored feedback reports addressing their self-efficacy, decisional balance and processes of change. The intervention website also includes features such as tips for exercising while caring for young children and local physical activity resources. Two key enhancements will be added to the intervention website in order to target the young adult cancer survivor population- 1. information pertinent to cancer survivors initiating an exercise program and 2. a peer-to-peer support component. Once these enhancements have been added, 10 young adult cancer survivors will evaluate the intervention and provide qualitative feedback. Additional revisions will be made to the intervention, as needed, based on this feedback. The intervention will then be pilot tested with a sample of 40 young adult cancer survivors. Participants will be randomly assigned to an intervention group (receiving 12 weeks of access to the intervention website) or a comparison group (receiving information on three cancer-specific Internet sites). Data on intervention feasibility and acceptability will be collected along with preliminary data on intervention effects (i.e., on physical activity level, mood, and fatigue). The latter will be used for effect size estimates when designing a future efficacy trial.
- Conditions
- Cancer
- Being tested
- Physical activity intervention
- Keywords
- young adult, cancer, exercise, physical activity
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
Comparison of providing access to a targeted physical activity web-site v. providing information on cancer-related websites
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention | Experimental | Participants in this arm will be given access to a website designed to help them increase their levels of physical activity Receives: Behavioral: Physical activity intervention |
| Cancer Website Control Group | Placebo comparator | Participants in this arm will be given information on cancer-related websites (that do not provide information on physical activity) Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measure: percentage of weeks that participants enter physical activity goals and information on the intervention website
Measured: 12 weeks
Acceptability measure: response to the item "In general how satisfied were you with the intervention?"
Measured: 12 weeks
Secondary outcomes (1)
Minutes of moderate-intensity activity on Seven Day PAR
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startMay 2009
- Primary completionApr 2011
- Study completionApr 2011
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Carolyn Rabin, The Miriam Hospital
- Investigators
- Carolyn Rabin, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791375
- Sponsor's protocol ID
- CA134197
- Other IDs
- 1R03CA134197
- Status last verified
- Apr 2012
- First submitted
- 12 Nov 2008
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Physical Activity Intervention for Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT00791375
- Acronym / sponsor ID
- CA134197
- Conditions
- Cancer
- Keywords
- young adult, cancer, exercise, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- May 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 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.
The goal of this study is to adapt a previously developed web-based physical activity intervention so that the intervention targets young adult cancer survivors(age 18 to 39). The web-based intervention will then be pilot tested to determine whether it is feasible for and acceptable to young adult cancer survivors; we hypothesize that the intervention will be both feasible and acceptable. Preliminary data on the effects of the intervention on physical activity level, mood and fatigue will also be collected.
Detailed description
Young adults diagnosed with cancer constitute a particularly vulnerable population whose medical and psychosocial needs are often overlooked. Those diagnosed with cancer between the ages of 18 and 39 face a number of increased risks including an increased risk of cardiovascular disease, second cancers, and emotional distress. Despite this, only a very small percentage of cancer research has focused on the survivorship issues of young adults. The goal of the proposed research is to address some of the unmet needs among young adult cancer survivors by developing and pilot testing a physical activity intervention for this population. Physical activity was selected as the target behavior as: 1. a high percentage of young adult cancer survivors have a sedentary lifestyle and 2. research has shown that cancer survivors who increase their physical activity experience improved cardiopulmonary function, reduced fatigue, enhanced mood and superior cancer outcomes. The intervention will be based on a previously developed, theoretically-grounded, tailored Internet intervention for sedentary adults. This previously developed intervention uses components of the Transtheoretical Model and Social Cognitive Theory to promote physical activity; for example, participants complete monthly questionnaires online and received tailored feedback reports addressing their self-efficacy, decisional balance and processes of change. The intervention website also includes features such as tips for exercising while caring for young children and local physical activity resources. Two key enhancements will be added to the intervention website in order to target the young adult cancer survivor population- 1. information pertinent to cancer survivors initiating an exercise program and 2. a peer-to-peer support component. Once these enhancements have been added, 10 young adult cancer survivors will evaluate the intervention and provide qualitative feedback. Additional revisions will be made to the intervention, as needed, based on this feedback. The intervention will then be pilot tested with a sample of 40 young adult cancer survivors. Participants will be randomly assigned to an intervention group (receiving 12 weeks of access to the intervention website) or a comparison group (receiving information on three cancer-specific Internet sites). Data on intervention feasibility and acceptability will be collected along with preliminary data on intervention effects (i.e., on physical activity level, mood, and fatigue). The latter will be used for effect size estimates when designing a future efficacy trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention | Experimental | Behavioral: Physical activity interventionParticipants in this arm will be given access to a website designed to help them increase their levels of physical activity |
| Cancer Website Control Group | Placebo comparator | Behavioral: Physical activity interventionParticipants in this arm will be given information on cancer-related websites (that do not provide information on physical activity) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age 18 to 39
- diagnosed with any form of cancer (except non-melanoma skin cancer) between the ages of 18 and 39 in the past 10 years
- completed all surgery, chemotherapy and radiation therapy
- currently in a cancer remission
- able to speak and write fluently in English
Key exclusion criteria (2 listed)
- currently pregnant or the intention to get pregnant
- the presence of a known medical condition (e.g., history of CVD) or history of severe psychiatric illness (e.g., psychotic disorder) making participation dangerous or very difficult
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 |
|---|---|---|
| Physical activity interventionComparison of providing access to a targeted physical activity web-site v. providing information on cancer-related websites | Behavioural | Cancer Website Control Group, Physical Activity Intervention |
Primary outcome
Feasibility measure: percentage of weeks that participants enter physical activity goals and information on the intervention website
Time frame: 12 weeks
Acceptability measure: response to the item "In general how satisfied were you with the intervention?"
Time frame: 12 weeks
1 secondary outcome
Minutes of moderate-intensity activity on Seven Day PAR
Time frame: 12 weeks
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 Apr 2012.
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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.
Carolyn Rabin principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Cancer, run by The Miriam Hospital 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 7 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 Apr 2012. 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. Some participants in this study may receive a placebo. 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?
Feasibility measure: percentage of weeks that participants enter physical activity goals and information on the intervention website (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 20 Apr 2012.