Prostate CancerNCT02043236
Strategies to Improve Bone Health in Men on ADT
A study testing Healthy bones pamphlet, Bone Health Care Coordinator and Letter to GP in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health in men receiving androgen deprivation therapy (ADT). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Healthy bones pamphlet, Bone Health Care Coordinator and Letter to GP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to 31 Dec 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Commencing or planning to continue ADT for a least 6 months 50 years or older English fluency Life expectancy >6 months
Who cannot join
- Prior Bone Mineral Density test within 2 years Prior visit at Osteoporosis Clinic within 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II RCT of Strategies to Improve Bone Health in Men on ADT
This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health in men receiving androgen deprivation therapy (ADT).
Read the detailed description
In this RCT the investigators are comparing 2 strategies to improve bone health to usual care. Strategy 1 - Patient and physician-specific written educational material. Pilot-tested customized written educational material about bone health for men on ADT will be used for this study. A customized letter will be prepared for the patient's primary care physician, with specific advice and recommendations for the targeted strategies. Both pamphlet and letter will include a list of additional resources. Strategy 2 - patient written material and a bone health care coordinator (BHCC). The same written patient material as in strategy 1 will be used, along with a BHCC who will follow the approach of successful studies and contact the patient by phone or arrange an in-person visit at the hospital if preferred by the patient. The BHCC will also encourage the patient to pursue a bone mineral density test (BMD) with their physician and adopt bone-appropriate diet, lifestyle, and supplement intake recommendations, and will follow up with the patient at least twice over the next 3 months to facilitate behavioural changes and BMD ordering. Counselling sessions are short, typically <15 min. The BHCC will also contact the patient's physician to help facilitate BMD testing. Time points in the study are baseline, 3-month follow up, and 6-month follow up.
Control group The control group consists of a wait-list control for 6 months, during which no specific recommendations or interventions will be made by the study team. Prostate Cancer (PC) clinicians can still provide usual care. At the end of 6 months, control group participants will be referred to the Osteoporosis Clinic at the University Health Network.
- Conditions
- Prostate Cancer
- Being tested
- Healthy bones pamphlet, Bone Health Care Coordinator, Letter to GP
- Keywords
- Prostate cancer, Androgen deprivation therapy, Bone health, Bone mineral density
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy bones pamphletBehavioural
Also called Building strong bones
written educational material
Bone Health Care CoordinatorBehavioural
Also called BHCC
The Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD.
Letter to GPBehavioural
The letter to the General Practitioner contains information about the study, recommendations for bone health, guidelines of Osteoporosis Canada, and the identical educational material that the participant received.
| Study group | Role | What they receive |
|---|---|---|
| Healthy bones pamphlet, letter to GP | Active comparator | Strategy 1: Written educational material to patient and GP Receives: Behavioral: Healthy bones pamphlet; Behavioral: Letter to GP |
| Healthy bones pamphlet, Bone Health Care Coordinator | Active comparator | Strategy 2: Written educational material to patient and counseling from a Bone Health Care Coordinator Receives: Behavioral: Healthy bones pamphlet; Behavioral: Bone Health Care Coordinator |
| Usual care | No intervention | Control group gets usual care from their oncologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient/physician satisfaction
Satisfaction will be measured with 5-point Likert scale ranging from poor to excellent and administered to patient, PC clinician, and General Physician
Measured: 6 months
Adherence rate
Adherence to following through on recommendations/referrals related to study intervention and clinical outcomes.
Measured: 6 months
Recruitment rate
Enrolled patients divided by approached eligible patients, and reasons for both ineligibility and refusal as documented in logs.
Measured: 6 months
Retention rate
Proportion of patients available for follow-up outcome assessment.
Measured: 6 months
BMD ordering
Rate of Bone Mineral Density ordering
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startNov 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 University Health Network, TorontoThe 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor
- Investigators
- Shabbir Alibhai, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043236
- Sponsor's protocol ID
- 13-6823
- Status last verified
- Mar 2018
- First submitted
- 20 Jan 2014
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alibhai SMH, Breunis H, Timilshina N, Hamidi MS, Cheung AM, Tomlinson GA, Manokumar T, Samadi O, Sandoval J, Durbano S, Warde P, Jones JM. Improving bone health in men with prostate cancer receiving androgen deprivation therapy: Results of a randomized phase 2 trial. Cancer. 2018 Mar 15;124(6):1132-1140. doi: 10.1002/cncr.31171. Epub 2017 Dec 6.
PubMed 29211305
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II RCT of Strategies to Improve Bone Health in Men on ADT
- ClinicalTrials.gov ID
- NCT02043236
- Acronym / sponsor ID
- 13-6823
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Androgen deprivation therapy, Bone health, Bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- Nov 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 Jan 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.
This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health in men receiving androgen deprivation therapy (ADT).
Detailed description
In this RCT the investigators are comparing 2 strategies to improve bone health to usual care. Strategy 1 - Patient and physician-specific written educational material. Pilot-tested customized written educational material about bone health for men on ADT will be used for this study. A customized letter will be prepared for the patient's primary care physician, with specific advice and recommendations for the targeted strategies. Both pamphlet and letter will include a list of additional resources. Strategy 2 - patient written material and a bone health care coordinator (BHCC). The same written patient material as in strategy 1 will be used, along with a BHCC who will follow the approach of successful studies and contact the patient by phone or arrange an in-person visit at the hospital if preferred by the patient. The BHCC will also encourage the patient to pursue a bone mineral density test (BMD) with their physician and adopt bone-appropriate diet, lifestyle, and supplement intake recommendations, and will follow up with the patient at least twice over the next 3 months to facilitate behavioural changes and BMD ordering. Counselling sessions are short, typically <15 min. The BHCC will also contact the patient's physician to help facilitate BMD testing. Time points in the study are baseline, 3-month follow up, and 6-month follow up.
Control group The control group consists of a wait-list control for 6 months, during which no specific recommendations or interventions will be made by the study team. Prostate Cancer (PC) clinicians can still provide usual care. At the end of 6 months, control group participants will be referred to the Osteoporosis Clinic at the University Health Network.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy bones pamphlet, letter to GP | Active comparator | Behavioral: Healthy bones pamphlet, Behavioral: Letter to GPStrategy 1: Written educational material to patient and GP |
| Healthy bones pamphlet, Bone Health Care Coordinator | Active comparator | Behavioral: Healthy bones pamphlet, Behavioral: Bone Health Care CoordinatorStrategy 2: Written educational material to patient and counseling from a Bone Health Care Coordinator |
| Usual care | No intervention | –Control group gets usual care from their oncologist. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Commencing or planning to continue ADT for a least 6 months 50 years or older English fluency Life expectancy >6 months
Key exclusion criteria (1 listed)
- Prior Bone Mineral Density test within 2 years Prior visit at Osteoporosis Clinic within 2 years
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 |
|---|---|---|
| Healthy bones pamphletAlso: Building strong boneswritten educational material | Behavioural | Healthy bones pamphlet, Bone Health Care Coordinator, Healthy bones pamphlet, letter to GP |
| Bone Health Care CoordinatorAlso: BHCCThe Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD. | Behavioural | Healthy bones pamphlet, Bone Health Care Coordinator |
| Letter to GPThe letter to the General Practitioner contains information about the study, recommendations for bone health, guidelines of Osteoporosis Canada, and the identical educational material that the participant received. | Behavioural | Healthy bones pamphlet, letter to GP |
Primary outcome
Patient/physician satisfaction
Time frame: 6 months
Satisfaction will be measured with 5-point Likert scale ranging from poor to excellent and administered to patient, PC clinician, and General Physician
Adherence rate
Time frame: 6 months
Adherence to following through on recommendations/referrals related to study intervention and clinical outcomes.
Recruitment rate
Time frame: 6 months
Enrolled patients divided by approached eligible patients, and reasons for both ineligibility and refusal as documented in logs.
Retention rate
Time frame: 6 months
Proportion of patients available for follow-up outcome assessment.
BMD ordering
Time frame: 6 months
Rate of Bone Mineral Density ordering
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 22 Mar 2018.
- Derived from this study: PubMed 29211305Alibhai SMH, Breunis H, Timilshina N, Hamidi MS, Cheung AM, Tomlinson GA, Manokumar T, Samadi O, Sandoval J, Durbano S, Warde P, Jones JM. Improving bone health in men with prostate cancer receiving androgen deprivation therapy: Results of a randomized phase 2 trial. Cancer. 2018 Mar 15;124(6):1132-1140. doi: 10.1002/cncr.31171. Epub 2017 Dec 6.
- Individual participant dataSharing planned: No
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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.
Shabbir Alibhai, MD principal investigator
UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy bones pamphlet, Bone Health Care Coordinator and Letter to GP in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 22 Mar 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 Canada. 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?
Patient/physician satisfaction (time frame: 6 months). The study lists 5 primary outcomes in all. 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 NCT02043236, 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 22 Mar 2018.