NCT01811264

Brief Summary

Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants in clinical encounters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

February 19, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2017

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

3.5 years

First QC Date

February 19, 2013

Last Update Submit

July 11, 2017

Conditions

Breast Cancer

Keywords

MetastaticQuality of lifeDecision making

Outcome Measures

Primary Outcomes (1)

  • Functional Assessment of Cancer Therapy - General (FACT-G)

    Evaluated at 30 minutes prior to, one week after, and 3 months after the patients visit with their doctor, this measure collects scales of the social and family well-being, emotional well-being, and functional well-being.

    Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit

Secondary Outcomes (1)

  • Rapid Estimate of Adult Literacy in Medicine (REALM-SF)

    Pre-Visit

Other Outcomes (1)

  • Decision Regret Scale

    Change in decision regret from pre-visit at 3 months post-visit

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy. Then they will be helped through the Patient-Participation Aid (PPA) by the research assistant (RA). Then they will meet with their doctor while the visit is video-recorded. After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication. Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.

Behavioral: Patient-Participation Aid

Usual Care

NO INTERVENTION

Participants will begin with a pre-visit structured interview to determine emotional and physical well-being, anxiety, depression, and self-efficacy. They will have their doctor's visit video recorded. After they will complete a post-visit interview to see if there were any health decisions made, patients level of involvement, and doctor communication.Follow up phone interviews will be conducted at 1 week and 3 months to assess patients self-reported changes in well-being, anxiety, depression, and decision regret.

Interventions

Patient-Participation AidBEHAVIORAL

The PPA consists of a folder that addresses the three behaviors we hope to influence: agenda setting, asking questions, and making preferences known. The information inside contains sample questions for each section, with room for the patient to write her own questions. Each section models behavior by giving context for the items and specific example questions. It also addresses barriers to understanding by indicating that it is acceptable to ask questions when something is not clear or terms are unfamiliar.

Also known as: PPA
Intervention

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients with metastatic breast cancer seeing one of the study physicians at one of the identified study clinics
  • age 21 or older
  • having suspected progression of metastatic disease

You may not qualify if:

  • patients with an uncorrectable hearing impairment or having limited English proficiency, as this would adversely affect their ability to communicate with the physician
  • patients with uncorrectable vision impairment, as this would make it impractical for the patient to read the intervention
  • patients too ill to meaningfully converse with the physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

H Lee Moffitt Comprehensive Cancer Center

Tampa, Florida, 33612, United States

Location

Feist-Weiller Cancer Center

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marla Clayman, Ph.D

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Faculty

Study Record Dates

First Submitted

February 19, 2013

First Posted

March 14, 2013

Study Start

December 1, 2013

Primary Completion

May 19, 2017

Study Completion

May 19, 2017

Last Updated

July 14, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)