NCT02032550

Brief Summary

The purpose of this study is to develop a preference based decision aid to assess the treatment preferences of prostate cancer patients, and to analyze the interaction of treatment preferences, type of treatment received and their relationship with health related quality of life, satisfaction with care, decision regret, and psychological health of men with localized prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
743

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

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

June 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2018

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 4, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

4.7 years

First QC Date

December 23, 2013

Results QC Date

March 23, 2018

Last Update Submit

July 17, 2020

Conditions

Prostate Cancer

Keywords

Localized prostate cancerPatient preferenceTreatment choiceDecision makingPatient centered outcomes

Outcome Measures

Primary Outcomes (1)

  • Change in Satisfaction With Care

    The investigators will measure Satisfaction with Care (PSQ-18). : The PSQ-18 scale measures satisfaction with care at baseline 3, 6, 12, and 24 months. Higher score indicates better satisfaction with care. Positive change indicates improvement in satisfaction with care.

    baseline, 3, 6, 12 and 24 months

Secondary Outcomes (7)

  • Generic Health Related Quality of Life (HRQoL)

    baseline to 24 month

  • Anxiety

    baseline, 3, 6, 12, and 24 months

  • Urinary Symptoms

    baseline, 3, 6, 12, and 24 months

  • Treatment Choice

    6 months

  • Depression

    baseline, 3, 6, 12, and 24 months

  • +2 more secondary outcomes

Other Outcomes (3)

  • Preference for Participation in Treatment Decision

    baseline, 3, 6, 12, and 24 months

  • Decision Conflict

    12 and 24 months

  • Physician Trust

    baseline

Study Arms (2)

Preference Based Decision Aid

EXPERIMENTAL

The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.

Other: Preference Based Decision Aid

Usual Care

NO INTERVENTION

Participants randomized into this group will have usual care from their doctors without any intervention

Interventions

Preference Based Decision AidOTHER

The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.

Preference Based Decision Aid

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed with non-metastatic prostate cancer
  • Has not yet started radiation or surgery
  • Provide informed consent

You may not qualify if:

  • Distant, metastatic prostate cancer at diagnosis
  • Has already begun treatment for prostate cancer
  • Unable to communicate in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Philadelphia Veteran's Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

  • Chhatre S, Jefferson A, Cook R, Meeker CR, Kim JH, Hartz KM, Wong YN, Caruso A, Newman DK, Morales KH, Jayadevappa R. Patient-centered recruitment and retention for a randomized controlled study. Trials. 2018 Mar 27;19(1):205. doi: 10.1186/s13063-018-2578-7.

    PMID: 29587805DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsPatient Preference

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPatient SatisfactionTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Ravishankar Jayadevappa
Organization
University of Pennsylvania
jravi@pennmedicine.upenn.edu
215-898-3798

Study Officials

  • Ravishankar Jayadevappa, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2013

First Posted

January 10, 2014

Study Start

June 1, 2013

Primary Completion

January 26, 2018

Study Completion

January 26, 2018

Last Updated

August 4, 2020

Results First Posted

August 4, 2020

Record last verified: 2020-07

Locations

US(3)