Questionnaire Administration for Atypical Ductal Hyperplasia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Atypical Ductal Hyperplasia+31 More
Questionnaire Administration - Other
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether an intervention that helps people think about the future can help them lose weight.

See full description

Eligible Conditions

  • Atypical Ductal Hyperplasia
  • Anatomic Stage 0 Breast Cancer AJCC v8
  • Breast Ductal Carcinoma In Situ
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Invasive Breast Carcinoma
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage 0 Breast Cancer AJCC v8
  • Anatomic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage 1 Breast Cancer AJCC v8
  • Prognostic Stage IA Breast Cancer AJCC v8
  • Prognostic Stage IIA Breast Cancer AJCC v8
  • Prognostic Stage IIB Breast Cancer AJCC v8
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IB Breast Cancer AJCC v8
  • Prognostic Stage 2 Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage 1 Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IA Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIB Breast Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Atypical Ductal Hyperplasia

Study Objectives

This trial is evaluating whether Questionnaire Administration will improve 1 primary outcome, 2 secondary outcomes, and 4 other outcomes in patients with Atypical Ductal Hyperplasia. Measurement will happen over the course of Baseline to 12 weeks.

Baseline to 12 weeks
Change in Insulin Resistance
Change in diet quality
Change in patient reported outcome (PRO)
Change in quantity of serum high-sensitivity C-reactive protein
Baseline to 24 weeks
Change in delay discounting rate
Up to 12 weeks
Feasibility measured by Adherence
Up to 24 weeks
Change in total body weight

Trial Safety

Safety Progress

1 of 3

Other trials for Atypical Ductal Hyperplasia

Trial Design

2 Treatment Groups

Arm II (ERT)
1 of 2
Arm I (EFT)
1 of 2
Active Control
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. Questionnaire Administration is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arm I (EFT)Patients participate in EFT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in EFT in their daily lives. Patients are asked to recall future positive experiences to create text cues which vividly describes these experiences.
Arm II (ERT)Patients participate in ERT over 12 weeks, in which they will receive prompts via a guided smartphone application to engage in ERT in their daily lives. Patients are asked to recall past positive experiences to create text cues which vividly describes these experiences.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2017
Completed Phase 4
~3220

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 weeks for reporting.

Who is running the study

Principal Investigator
S. S.
Sagar Sardesai, Principal Investigator
Ohio State University Comprehensive Cancer Center

Closest Location

Ohio State University Comprehensive Cancer Center - Columbus, OH

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age >= 18 years
Breast cancer (BC) survivors (pathologically proven ductal carcinoma in situ or stage I-III invasive BC and completed primary breast surgery, radiation, chemotherapy >= 21 days prior to enrollment)
Body mass index (BMI) >= 25 kg/m^2
Endocrine and HER2- directed therapy is permitted
Have access to a mobile electronic device
Motivated to lose weight (readiness to change assessment)

Patient Q&A Section

What is the latest research for weight loss?

"At present, the mainstay of treatment is based on behavioural therapy with calorie restriction combined with physical activities such as aerobic exercises and resistance training. Although the effectiveness of these interventions has been established, the maintenance of long-term changes remains elusive. Besides, lifestyle modification programs are typically targeted towards improving patients' overall health rather than weight loss. More research is needed to explore whether the newer pharmacological therapies could be effective in achieving weight loss." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for weight loss?

"Clinical trial participation was strongly associated with several demographic characteristics. More than half of participants who reported being willing to participate in a clinical trial were not enrolled." - Anonymous Online Contributor

Unverified Answer

How many people get weight loss a year in the United States?

"The number of people who get weight loss in the U.S. is relatively small. This may be due to the fact that obesity prevalence is rising as a result of an increase in sedentary lifestyles. While there are numerous health benefits associated with losing weight, the cost of achieving this goal needs to be taken into consideration." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of questionnaire administration?

"The reasonably high level of missing data suggests that the inventory may have been poorly received by study participants. However, the findings of moderate correlations among the items and their subscales suggest that this type of instrument could serve as an appropriate proxy measure of post-intervention change. This might be helpful in assessing the impact of multi-component weight management programs such as the DASH diet." - Anonymous Online Contributor

Unverified Answer

Is questionnaire administration typically used in combination with any other treatments?

"Aside from being a useful tool to identify patients who are likely to benefit from treatment, the questionnaire was easily administered and might be useful in detecting patients who are at risk for underreporting their actual weight loss. In addition, the patient's knowledge of his/her progress might influence his/her motivation level to lose weight." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in questionnaire administration for therapeutic use?

"The current study showed that the use of pen and ink and computerized formats resulted in higher data quality than paper and pencil. However, there were no differences between the two formats with respect to patient satisfaction. In future studies, paper and pencil would probably be preferable given the limited time resources faced by clinicians and researchers." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving questionnaire administration?

"The questionnaire was well accepted by patients and physicians. Furthermore, it had acceptable psychometric properties. Questionnaire administration may be a useful tool for screening for depression among patients undergoing weight loss surgery." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of weight loss?

"There is no single reason why people lose weight; rather, many factors contribute to weight loss. Body fat distribution and nutritional habits play a major role in determining how much weight a person will lose. More research needs to be conducted to better understand weight loss." - Anonymous Online Contributor

Unverified Answer

How quickly does weight loss spread?

"This pilot study showed that patients' changes were rapid. The greatest changes occurred at 1 year postoperatively. However, the results also show that there may be continuing change even at 3 years. The findings support the need for further research into the long-term effects of bariatric surgery." - Anonymous Online Contributor

Unverified Answer

Does weight loss run in families?

"Although this study has several limitations, we suggest that further research into familial effects of weight loss may help clarify the genetic basis of obesity." - Anonymous Online Contributor

Unverified Answer

Can weight loss be cured?

"The current data suggest that substantial weight loss is achievable after a short period of time and that there is a high probability of sustained weight regain following cessation of the treatment. Thus it appears that although weight loss is not cure, it does appear to be possible to achieve significant weight loss in a relatively short time frame and then manage successfully to prevent weight regain." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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