Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

The brochure with standard information on surgery for early-stage breast cancer

The brochure that incorporates additional information on the rates of regret after surgical treatment of early-stage breast cancer.

Females will receive standard decisions aid for early stage breast cancer.

Standard Decision Aid

Females will receive anticipated regret-augmented version for early breast cancer.

Post-surgical Regret Decision Aid

Lee Fleisher, MD

The purpose of this study is to investigate the impact of incorporating "anticipated regret " into standard patient decision aids. Participants in the Wharton Behavioral Lab will be administered a standard patient decision aid and an "anticipated regret" augmented decision aid. Participants will complete a computerized survey about their experiences with each version, and their answers will be assessed for potential differences associated with the incorporation of "Anticipated Regret."

Participants will be recruited through the Wharton Behavioral Lab. Upon arrival males will be provided with two decision aids focusing on prostate cancer, while females will be provided with two decision aids focusing on early breast cancer. One of these decision aids will be a standard version, and one of these will be the anticipated regret-augmented version. Participants will be randomized to which version they receive first to minimize the effect of presentation order. After reviewing the materials, participants will immediately complete a computerized survey at their work stations that will ask them to answer questions based on the materials presented as well as how any hypothetical treatment decisions they would be asked to make would have been influenced by them. Because these are healthy subjects participating in a hypothetical decision-making process for sole purpose of research, the intervention can neither be categorized as experimental or as the standard of care.

Impact of Anticipated Regret Incorporation Into Patient Decision Aids

Impact of Anticipated Regret on Decision-Making in Preference Sensitive Care for Breast and Prostate Cancer

Compare decisions about a hypothetical surgery for breast cancer, and examined whether regret is a consideration in treatment decisions between those who received the experimental and those who received the standard version of the decision aid. The values represent numbers of participants who reported that regret played a role in their decision-making.

University of Pennsylvania

Females will receive standard decisions aid for early stage breast cancer.

Survey: Standard

Survey: Standard Version

Females will receive anticipated regret-augmented version for early breast cancer.

Survey: Regret

Survey: Anticipated Regret Version

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Two participants did not complete the demographic questions. As such only 94 are being analyzed.

Lee Fleisher

Difference in Consideration of Regret

Overall Study

Symptoms and General Pathology

Behaviors and Mental Disorders

Frailty

Quality of Life

Pancreatectomy, Esophagectomy, Gastrectomy and Hepatectomy

High Risk Abdominal Surgery

Julien Maillard, MD

The investigators plan to measure the changes of health-related quality of life (HRQoL) at 6 months and 12 months after the following high-risk oncological abdominal surgery: gastrectomy, esophagectomy, pancreatectomy and hepatectomy. The investigators will measure the HRQoL using the validated EORTC QLQ-C30 questionnaire before and at 6 months and 12 month after the surgery. The investigators will identify phenotypes of HRQoL changes (improvement, stability and deterioration) at 6 months and 12 months after surgery.

The second aim is to assess the regret of the patient at 6 months and 12 months regarding his/her decision to undergo surgery. The investigators will also assess the regret of the next of kin at 6 months regarding the decision to undergo surgery.

This descriptive, prospective, observational, single-centre cohort study aims to: identify phenotypes of HRQoL changes after abdominal surgical oncology (improvement, stability and deterioration); assess the regret of patients regarding their decision to undergo surgical oncology at 6 months and 12 months; assess the regret of the next of kin regarding the decision of the patient to undergo surgical oncology at 6 months and 12 months. The investigators will include patients scheduled for the following elective abdominal cancer surgery: gastrectomy; esophagectomy; pancreas resection and hepatectomy. The investigators will assess HRQoL using the validated EORTC QLQ-C30 Summary Score before and 6 months and 12 months after surgery. The cut-offs for the three phenotypes of HRQoL changes will be defined using the minimal clinically important difference (MCID) of 10 points. The investigators will assess regret using the Decision Regret Scale (DRS) at 6 months and 12 months after surgery.

The expected results are: The investigators can identify phenotypes of HRQoL changes after surgical oncology using the EORTC QLQ-C30 Summary Score; the investigators will describe the distribution of these phenotypes and will find an association with the pre-existing frailty. The investigators can describe the extent of the regret of the patient and of the next of kin at 6 months using the DRS. The investigators will observe an association between the DRS score at 6 months and the HRQoL Summary Score change. The investigators will not observe a relationship between the DRS score of patients and next-of-kins.

Quality of Life and High-Risk Abdominal Cancer Surgery

Changes of Health-related Quality of Life 6 Months After High-risk Oncological Upper Gastrointestinal and Hepatobiliary Surgery: a Single-centre Prospective Observational Study (ChangeQol Study)

Decision Regret Scale. Minimum 0, Maximum 100

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Impact of Anticipated Regret Incorporation Into Patient Decision Aids	NCT02563808	Regret	Standard Decisi... Post-surgical R...	18 Years -	University of Pennsylvania
Quality of Life and High-Risk Abdominal Cancer Surgery	NCT04444544	Quality of Life Surgery Cancer Frailty	High Risk Abdom...	18 Years -	University Hospital, Geneva
Quality of Life and High-Risk Abdominal Cancer Surgery	NCT04444544	Quality of Life Surgery Cancer Frailty	High Risk Abdom...	18 Years -	University Hospital, Geneva

Spots Global Cancer Trial Database for regret

Every month we try and update this database with for regret cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for regret

Every month we try and update this database with for regret cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for regret cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.