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Spots Global Cancer Trial Database for Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

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Trial Identification

Brief Title: Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

Official Title: Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer

Study ID: NCT01811264

Conditions

Breast Cancer

Study Description

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.

Detailed Description: The team has developed a brief Patient Participation Aid (PPA) to promote patient health literacy and encourage women to be active in the decisions that are being made about their healthcare which will lead to their satisfaction with healthcare and improves their psychosocial well-being. The paper-based PPA uses adult learning principles to limit and sequence plain language messages that have been framed from a patient's perspective. The PPA uses theory-based design to increase patients' involvement in the medical visit by modeling - through text and images - how a patient can: 1) set the visit agenda, 2) formulate questions, and 3) assert personal preferences. The specific aims of this study are to: 1- Assess the effectiveness of the PPA to increase patient involvement during clinical encounters. 2- Evaluate the effectiveness of the PPA to improve patient psychosocial outcomes. 3- Explore if the effect of the PPA varies by patients' literacy skills. To achieve this aims, the investigators will conduct a randomized controlled trial to evaluate the PPA among patients with a new diagnosis or progression of metastatic breast cancer at two cancer centers that serve diverse patient populations.

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

H Lee Moffitt Comprehensive Cancer Center, Tampa, Florida, United States

Feist-Weiller Cancer Center, Shreveport, Louisiana, United States

Contact Details

Name: Marla Clayman, Ph.D

Affiliation: Northwestern University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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