NCT05228210

Brief Summary

The concept of self-efficacy is a major predictor of physical, psychological, social and overall quality of life (QoL) among breast cancer survivors (BCS). Because survivor and partner outcomes are often linked, it is reasonable to hypothesize that self-efficacy is an important predictor of physical, psychological, social and overall QoL in partners as well. However, this hypothesis has yet to be tested, in part because no scale exists to measure cancer-related self-efficacy in partners. Development and psychometric testing of such a scale is a critical first step in developing a theoretical model predicting QoL in this population. Partners of BCS often report lower QoL compared to partners of healthy women, making them an important focus of research. During the award period, the applicant will follow standard instrument development procedures to develop the Breast Cancer Self-Efficacy Scale for Partners (BCSES-P) and test the scale's psychometric properties using a large and diverse sample of partners of breast cancer survivors.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

July 2, 2021

Last Update Submit

March 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fear of Cancer Progression and Recurrence (FCR7)

    7-item scale assessing concerns that the cancer will progress or return, previously tested in samples of breast cancer survivor caregivers/spouses, Cronbach alpha=.91.

    Day 1

Secondary Outcomes (1)

  • PROMIS Depression Short Form (8 items)

    Day 1

Study Arms (1)

Partners of breast cancer survivors

Convenience sample of partners/significant others/spouses of breast cancer survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential participants will be identified through multiple venues: Facebook, RED Alliance, community organizations in Indianapolis and surrounding areas, inResearch.org, Army of Love, ResNet (the latter three are research participant registries).

You may qualify if:

  • Identifies as a partner, significant other, or spouse of an individual diagnosed with non-metastatic breast cancer
  • Is 18 years of age or over
  • Is able and willing to attend a focus group, individual interview, or complete an online survey
  • Is able to access the internet
  • Is able to carry on normal everyday conversation

You may not qualify if:

  • · Partners who have separated or divorced since survivors' diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrea A Cohee

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 2, 2021

First Posted

February 8, 2022

Study Start

September 1, 2019

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations