Sedentary LifestyleNCT01845519
Step by Step: A Tailored Walking Intervention for Breast Cancer Survivors
A study testing Tailored Email and Targeted Email in people with Sedentary Lifestyle and Breast Neoplasms, run by Leanne Kaye at 1 site in United States.
Trial summary
This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm randomized walking intervention. All intervention materials will be delivered electronically. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Sedentary Lifestyle, Breast Neoplasms, Survival Rate (Survivorship)
- What is being tested?
- Tailored Email and Targeted Email
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2014
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 40-70 years of age
- History of breast cancer stage I-II
- 2-10 years post-treatment
- Sedentary
- Technology access and skills
Show all 9Show fewer
- Regular access to personal computer/ broadband internet and email account
- Comfortability using internet, and web-based tools
- US Resident
Who cannot join
- Concurrent enrollment in another physical activity/ lifestyle/ weight loss intervention program/study
- Current secondary cancer diagnosis/ treatment
- Inability to ambulate
- Refusal to wear personal activity monitor (FitBit Ultra) for the duration of the study
- Engaging in regular moderate to vigorous physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center/ University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Feasibility of a Technology-based Intervention to Reach Inactive Breast Cancer Survivors and Objectively Track Step Activity.
This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm randomized walking intervention. All intervention materials will be delivered electronically.
The investigators hypothesize that at the end of 12-weeks, participants randomized to the intervention group will engage in more weekly steps than those participants randomized to the comparison group.
Read the detailed description
More than two-thirds of breast cancer survivors are physically inactive. Inactivity is known to negatively impact both morbidity and mortality, and is especially pronounced among cancer survivors. Self-directed interventions targeting inactivity among breast cancer survivors often report clinically insignificant behavior change. More successful behavior change interventions have suggested that tailoring and, more recently, the fostering of intrinsic motivation, may have improved outcomes. However, no interventions to date have utilized these approaches to increase physical activity among sedentary cancer survivors.
AIM 1: Develop and test intervention (tailored) and comparison group (targeted) messages in a sample of sedentary women to determine message acceptability.
AIM 2: Determine the efficacy of a 12-week tailored intervention to increase the number of weekly steps taken among sedentary post-treatment breast cancer survivors compared to a 12-week, targeted intervention.
- Being tested
- Tailored Email, Targeted Email
- Medical subject headings
- Sedentary Behavior, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored EmailBehavioural
Participants will receive tailored emails.
Targeted EmailBehavioural
Participants will receive targeted emails.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Group | Experimental | Not described Receives: Behavioral: Tailored Email |
| Targeted Group | Active comparator | Not described Receives: Behavioral: Targeted Email |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).
The primary outcome will be measured using weekly step data as measured by a commercially available accelerometer. The primary outcome will be the difference in weekly steps between the intervention and comparison group at the end of the intervention (week 12).
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 posted3 May 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary LifestyleStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leanne Kaye
- Sponsor type
- University, hospital or other
- Collaborators
- UNC Lineberger Comprehensive Cancer Center, University of North Carolina
- Responsible party
- Sponsor-investigator, Leanne Kaye, UNC Lineberger Comprehensive Cancer Center
- Investigators
- Leanne Kaye, PhD, Principal investigator, University of North CarolinaDianne Ward, Ed.D, Study director, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845519
- Sponsor's protocol ID
- IRB 121775
- Status last verified
- Dec 2013
- First submitted
- 25 Apr 2013
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Technology-based Intervention to Reach Inactive Breast Cancer Survivors and Objectively Track Step Activity.
- ClinicalTrials.gov ID
- NCT01845519
- Acronym / sponsor ID
- IRB 121775
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Leanne KayeUniversity, hospital or other
- Collaborators
- UNC Lineberger Comprehensive Cancer Center, University of North Carolina
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 May 2013 (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 aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm randomized walking intervention. All intervention materials will be delivered electronically.
The investigators hypothesize that at the end of 12-weeks, participants randomized to the intervention group will engage in more weekly steps than those participants randomized to the comparison group.
Detailed description
More than two-thirds of breast cancer survivors are physically inactive. Inactivity is known to negatively impact both morbidity and mortality, and is especially pronounced among cancer survivors. Self-directed interventions targeting inactivity among breast cancer survivors often report clinically insignificant behavior change. More successful behavior change interventions have suggested that tailoring and, more recently, the fostering of intrinsic motivation, may have improved outcomes. However, no interventions to date have utilized these approaches to increase physical activity among sedentary cancer survivors.
AIM 1: Develop and test intervention (tailored) and comparison group (targeted) messages in a sample of sedentary women to determine message acceptability.
AIM 2: Determine the efficacy of a 12-week tailored intervention to increase the number of weekly steps taken among sedentary post-treatment breast cancer survivors compared to a 12-week, targeted intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Group | Experimental | Behavioral: Tailored Email |
| Targeted Group | Active comparator | Behavioral: Targeted Email |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- 40-70 years of age
- History of breast cancer stage I-II
- 2-10 years post-treatment
- Sedentary
Key exclusion criteria (5 listed)
- Concurrent enrollment in another physical activity/ lifestyle/ weight loss intervention program/study
- Current secondary cancer diagnosis/ treatment
- Inability to ambulate
- Refusal to wear personal activity monitor (FitBit Ultra) for the duration of the study
- Engaging in regular moderate to vigorous 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 |
|---|---|---|
| Tailored EmailParticipants will receive tailored emails. | Behavioural | Tailored Group |
| Targeted EmailParticipants will receive targeted emails. | Behavioural | Targeted Group |
Primary outcome
Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).
Time frame: 12 weeks
The primary outcome will be measured using weekly step data as measured by a commercially available accelerometer. The primary outcome will be the difference in weekly steps between the intervention and comparison group at the end of the intervention (week 12).
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 1 Jun 2015.
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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.
Leanne Kaye, PhD principal investigator
University of North Carolina
Dianne Ward, Ed.D study director
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Email and Targeted Email in people with Sedentary Lifestyle and Breast Neoplasms, run by Leanne Kaye 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 9 inclusion and 5 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 1 Jun 2015. 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?
Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12). (time frame: 12 weeks). 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 1 Jun 2015.