NCT01973673

Brief Summary

Prostate cancer patients receiving hormone treatment (androgen deprivation therapy, or ADT) are at increased risk of developing bone loss and osteoporosis as side effects. To prevent this, guidelines recommend participation in healthy bone behaviours including weight-bearing exercise and adequate calcium/vitamin D intake. However, prior studies have shown that patients are not regularly screened or counselled regarding healthy bone behaviours while receiving ADT. Maintaining bone health in prostate cancer patients is important because men on ADT are at increased risk of fractures. In this study, the investigators will examine whether an intervention designed to improve healthy bone behaviours among prostate cancer patients on ADT can be implemented. The intervention consists of a written "healthy bones prescription", brief verbal counseling, and printed educational materials for participants. Investigators hope to obtain an initial estimate of whether the intervention works. They also hope to show that this simple intervention can be implemented in a real, working cancer clinic. The investigators hypothesize that an intervention to improve bone health in prostate cancer patients receiving ADT (healthy bones prescription, verbal counseling, and printed educational materials) is effective, implementable, and accepted by clinicians and patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

3.5 years

First QC Date

September 30, 2013

Last Update Submit

May 3, 2017

Conditions

Locally Advanced Malignant Neoplasm

Keywords

prostate cancerADTbone health

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

    Proportion of eligible and consented patients who complete study follow-up, as a measure of study feasibility

    6 months

  • Study completion and retention rate

    Change in patient-reported daily calcium intake, as a measure of intervention efficacy

    3 months

  • Intervention efficacy

    Change in patient-reported weekly exercise duration, as a measure of intervention efficacy

    3 months

Secondary Outcomes (4)

  • Clinical outcome

    6 months

  • Clinical outcome capture rate

    6 months

  • Questionnaire, and Osteoporosis Health Belief Scale

    3 months

  • BMD monitoring

    6 months

Study Arms (2)

Bone health educational materials

ACTIVE COMPARATOR

Bone health written educational materials, Bone health prescription,verbal counselling

Behavioral: Bone health educational materials

Usual care

NO INTERVENTION

Usual clinical care to be provided by oncologists.

Interventions

Bone health educational materialsBEHAVIORAL
Bone health educational materials

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer patients receiving ADT at study entry (for a maximum of 12 months prior to study entry or planning to receive ADT within 3 weeks of study entry), for an expected duration of \>6 months; Eastern Cooperative Oncology Group (ECOG) performance status \<3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Tsang DS, Jones JM, Samadi O, Shah S, Mitsakakis N, Catton CN, Jeon W, To J, Breunis H, Alibhai SMH. Healthy Bones Study: can a prescription coupled with education improve bone health for patients receiving androgen deprivation therapy?-a before/after study. Support Care Cancer. 2018 Aug;26(8):2861-2869. doi: 10.1007/s00520-018-4150-0. Epub 2018 Mar 12.

    PMID: 29532243DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Shabbir Alibhai, MD

    UHN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2013

First Posted

October 31, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)