Breast CancerNCT02189278
Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
A study testing Psychosocial Intervention in people with Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
Evidence-based guidelines recommend cancer surveillance procedures for breast cancer survivors including physical examination, mammography, breast self-exam, and gynecologic follow-up. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Psychosocial Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 12 Jun 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years of age or older
- Diagnosis of Stage I to IIIA breast cancer
- Within 1 to 5 years post primary cancer treatment (i.e., surgery, chemotherapy, and/or radiation therapy)
- No diagnosis of recurrent breast cancer or a new primary cancer
- Able to provide meaningful consent
Who cannot join
- < 21 years of age
- Unable to provide meaningful consent
- Surgically treated with bilateral mastectomy
Trial locations and contacts
1 site in 1 country.
About this study
Evidence-based guidelines recommend cancer surveillance procedures for breast cancer survivors including physical examination, mammography, breast self-exam, and gynecologic follow-up. The early detection of recurrent and new cancers can best be achieved through the combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55% of breast cancer survivors do not undergo these procedures as recommended. This study tests a telephone-based psychosocial intervention aimed at improving adherence to recommended surveillance in breast cancer survivors. The psychosocial intervention for improving adherence is compared to treatment as usual.
- Conditions
- Breast Cancer
- Being tested
- Psychosocial Intervention
- Keywords
- Breast Cancer, Surveillance, Mammography, Adherence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial InterventionBehavioural
Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial Intervention | Experimental | Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance. Receives: Behavioral: Psychosocial Intervention |
| Treatment as usual | No intervention | Treatment as usual control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surveillance adherence
Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)
Measured: 15 month follow-up
Secondary outcomes (2)
Gynecologic exam adherence
Receipt of recommended gynecologic exams (coded 0=no, 1=yes)
Measured: 15 month follow-up
Breast self-exam adherence
Frequency of conducting breast self-exams assessed via patient report.
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startOct 2013
- Primary completion12 Jun 2017
- Study completion12 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rebecca A Shelby, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189278
- Sponsor's protocol ID
- Pro00022895
- Other IDs
- 5K07CA138767
- Status last verified
- Sep 2018
- First submitted
- 10 Jul 2014
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Recommended Surveillance in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02189278
- Acronym / sponsor ID
- Pro00022895
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Surveillance, Mammography, Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2013
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 12 Jun 2017 (actual)
- First posted
- 14 Jul 2014 (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.
Evidence-based guidelines recommend cancer surveillance procedures for breast cancer survivors including physical examination, mammography, breast self-exam, and gynecologic follow-up. The early detection of recurrent and new cancers can best be achieved through the combined, on schedule use of these surveillance procedures. Yet, data suggest that up to 55% of breast cancer survivors do not undergo these procedures as recommended. This study tests a telephone-based psychosocial intervention aimed at improving adherence to recommended surveillance in breast cancer survivors. The psychosocial intervention for improving adherence is compared to treatment as usual.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Intervention | Experimental | Behavioral: Psychosocial InterventionTelephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance. |
| Treatment as usual | No intervention | –Treatment as usual control. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 21 years of age or older
- Diagnosis of Stage I to IIIA breast cancer
- Within 1 to 5 years post primary cancer treatment (i.e., surgery, chemotherapy, and/or radiation therapy)
- No diagnosis of recurrent breast cancer or a new primary cancer
- Able to provide meaningful consent
Key exclusion criteria (3 listed)
- < 21 years of age
- Unable to provide meaningful consent
- Surgically treated with bilateral mastectomy
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 |
|---|---|---|
| Psychosocial InterventionTelephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance. | Behavioural | Psychosocial Intervention |
Primary outcome
Surveillance adherence
Time frame: 15 month follow-up
Receipt of recommended mammograms and clinical breast exams (coded 0=no, 1=yes)
2 secondary outcomes
Gynecologic exam adherence
Time frame: 15 month follow-up
Breast self-exam adherence
Time frame: 6 month follow-up
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 Oct 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.
Rebecca A Shelby, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Intervention in people with Breast Cancer, run by Duke 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 5 inclusion and 3 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 Oct 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.
What does the primary outcome measure?
Surveillance adherence (time frame: 15 month follow-up). 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 3 Oct 2018.