Prostate CancerNCT01937585
Trial of Print Messages to Support the Role of Partners in Promoting Provider Discussions About Prostate Cancer Screening Among AA Men
A study testing Partner and CDC brochure condition and CDC brochure only condition in people with Prostate Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether female partners of African American men can promote initiation of a discussion with a healthcare provider about prostate cancer screening when the partner is supported by a print message designed to provide relevant information and strategies for her to use in this… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Partner and CDC brochure condition and CDC brochure only condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Nov 2010
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- U.S. female aged 18 and over, and having an AA male partner between the ages of 35 and 69 with no history of a Pca diagnosis
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Evaluation of a Culturally Targeted, Personalized Mail-Home Brochure Directed to Partners of At-Risk Men to Facilitate Prostate Cancer Risk Assessment
The purpose of this study is to determine whether female partners of African American men can promote initiation of a discussion with a healthcare provider about prostate cancer screening when the partner is supported by a print message designed to provide relevant information and strategies for her to use in this effort.
Read the detailed description
Objective: Although AA men are at elevated risk for prostate cancer (Pca), medical guidelines do not present consistent screening recommendations for this group. However, all guidelines stress the need for screening decision making with a provider. This study evaluated the effectiveness of a brochure designed for the female partners of AA men, designed to help promote such discussion on the part of their mates. We also explored the effect of the partner's monitoring style (i.e., the extent to which the partner typically attends to health threats) on promoting discussion.
Methods: Female partners of AA men (N=231) were randomized to receive either a Pca screening CDC brochure for AA men, combined with a "partner" brochure containing strategies to promote men's initiation of a provider visit to discuss screening, or the CDC brochure only, and completed pre- and post-intervention surveys online.
Conclusions: High monitoring partners may be effective in influencing their AA mates to initiate provider discussion, particularly when tailored messaging is provided.
- Conditions
- Prostate Cancer
- Being tested
- Partner and CDC brochure condition, CDC brochure only condition
- Keywords
- prostate cancer, partner, communication messages, monitoring style, AA men
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner and CDC brochure conditionBehavioural
Receipt of a brochure designed for female partners of African American men designed to provide information about prostate cancer screening and strategies for influencing her mate to schedule a discussion with a health care provider about whether to undergo prostate cancer screening, in combination with receipt of the comparator brochure (CDC brochure for African American about prostate cancer screening).
CDC brochure only conditionBehavioural
Receipt of CDC brochure by female partners of African American men designed to provide African American men information and guidance concerning whether to undergo PSA and/or DRE screening for prostate cancer
| Study group | Role | What they receive |
|---|---|---|
| CDC brochure only condition | Active comparator | Receipt of CDC brochure by female partners of African American men designed to provide African American men information and guidance concerning whether to undergo PSA and/or DRE screening for prostate cancer Receives: Behavioral: CDC brochure only condition |
| Partner and CDC brochure condition | Experimental | Receipt of a brochure designed for female partners of African American men designed to provide information about prostate cancer screening and strategies for influencing her mate to schedule a discussion with a health care provider about whether to undergo prostate cancer screening, in combination with receipt of the comparator brochure (CDC brochure for African American about prostate cancer screening). Receives: Behavioral: Partner and CDC brochure condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partner-reported actions of mate to initiate a provider visit to discuss prostate cancer screening
Measured: Two weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Knowledge Networks
- Responsible party
- Sponsor
- Investigators
- Suzanne M Miller, PhD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937585
- Sponsor's protocol ID
- CTMHB-DOD
- Other IDs
- W81XWH-06-1-0099
- Status last verified
- Sep 2013
- First submitted
- 30 Aug 2013
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sajid S, Kotwal AA, Dale W. Interventions to improve decision making and reduce racial and ethnic disparities in the management of prostate cancer: a systematic review. J Gen Intern Med. 2012 Aug;27(8):1068-78. doi: 10.1007/s11606-012-2086-5.
PubMed 22798216
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Culturally Targeted, Personalized Mail-Home Brochure Directed to Partners of At-Risk Men to Facilitate Prostate Cancer Risk Assessment
- ClinicalTrials.gov ID
- NCT01937585
- Acronym / sponsor ID
- CTMHB-DOD
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, partner, communication messages, monitoring style, AA men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Knowledge Networks
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Sep 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.
The purpose of this study is to determine whether female partners of African American men can promote initiation of a discussion with a healthcare provider about prostate cancer screening when the partner is supported by a print message designed to provide relevant information and strategies for her to use in this effort.
Detailed description
Objective: Although AA men are at elevated risk for prostate cancer (Pca), medical guidelines do not present consistent screening recommendations for this group. However, all guidelines stress the need for screening decision making with a provider. This study evaluated the effectiveness of a brochure designed for the female partners of AA men, designed to help promote such discussion on the part of their mates. We also explored the effect of the partner's monitoring style (i.e., the extent to which the partner typically attends to health threats) on promoting discussion.
Methods: Female partners of AA men (N=231) were randomized to receive either a Pca screening CDC brochure for AA men, combined with a "partner" brochure containing strategies to promote men's initiation of a provider visit to discuss screening, or the CDC brochure only, and completed pre- and post-intervention surveys online.
Conclusions: High monitoring partners may be effective in influencing their AA mates to initiate provider discussion, particularly when tailored messaging is provided.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDC brochure only condition | Active comparator | Behavioral: CDC brochure only conditionReceipt of CDC brochure by female partners of African American men designed to provide African American men information and guidance concerning whether to undergo PSA and/or DRE screening for prostate cancer |
| Partner and CDC brochure condition | Experimental | Behavioral: Partner and CDC brochure conditionReceipt of a brochure designed for female partners of African American men designed to provide information about prostate cancer screening and strategies for influencing her mate to schedule a discussion with a health care provider about whether to undergo prostate cancer screening, in combination with receipt of the comparator brochure (CDC brochure for African American about prostate cancer screening). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- U.S. female aged 18 and over, and having an AA male partner between the ages of 35 and 69 with no history of a Pca diagnosis
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Partner and CDC brochure conditionReceipt of a brochure designed for female partners of African American men designed to provide information about prostate cancer screening and strategies for influencing her mate to schedule a discussion with a health care provider about whether to undergo prostate cancer screening, in combination with receipt of the comparator brochure (CDC brochure for African American about prostate cancer screening). | Behavioural | Partner and CDC brochure condition |
| CDC brochure only conditionReceipt of CDC brochure by female partners of African American men designed to provide African American men information and guidance concerning whether to undergo PSA and/or DRE screening for prostate cancer | Behavioural | CDC brochure only condition |
Primary outcome
Partner-reported actions of mate to initiate a provider visit to discuss prostate cancer screening
Time frame: Two weeks post baseline
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 9 Sep 2013.
- Background: PubMed 22798216Sajid S, Kotwal AA, Dale W. Interventions to improve decision making and reduce racial and ethnic disparities in the management of prostate cancer: a systematic review. J Gen Intern Med. 2012 Aug;27(8):1068-78. doi: 10.1007/s11606-012-2086-5.
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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.
Suzanne M Miller, PhD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner and CDC brochure condition and CDC brochure only condition in people with Prostate Cancer, run by Fox Chase Cancer Center 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 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 9 Sep 2013. 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?
Partner-reported actions of mate to initiate a provider visit to discuss prostate cancer screening (time frame: Two weeks post baseline). 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 NCT01937585, which also lists 1 linked publication.
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 9 Sep 2013.