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Prospective Thinking in Hormone-Responsive Breast Cancer

Primary Purpose

Hormone Receptor Positive Malignant Neoplasm of Breast

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Episodic future thinking
Episodic recent thinking
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hormone Receptor Positive Malignant Neoplasm of Breast

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-80 years
  • Female
  • Must have a history of hormone responsive breast cancer treated with curative intent and have been recommended/prescribed adjuvant HT (tamoxifen, anastrozole, letrozole or exemestane) by their physician.

Exclusion Criteria:

  • Recurrent breast cancer
  • Adjuvant hormone therapy is no longer medically appropriate/advisable
  • Incapable/ without capacity to provide personal consent
  • Suffers from cognitive or physical impairments which interfere with medication self- administration and/or participation in episodic thinking
  • Receiving HT for metastatic disease

Sites / Locations

  • Virginia Tech Carilion Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Episodic future thinking

Episodic recent thinking (control)

Arm Description

Participants will complete a guided interview designed to elicit a number of personalized events that are likely to occur during various future time frames (e.g., 1 day, 1 week, 3 months, 1 year, etc.), as well as text cues designed to prompt episodic future thinking (e.g., "In 3 months, I will be at my daughter's wedding"). Text cues will be presented during subsequent behavioral tasks and participants will be asked to think vividly about these events.

Participants will complete a guided interview designed to elicit a number of personalized events that occurred in the recent past (e.g., earlier today, yesterday), as well as text cues designed to prompt episodic thinking (e.g., "Earlier today, I was playing tennis with my wife."). Text cues will be presented during subsequent behavioral tasks and participants will be asked to think vividly about these events.

Outcomes

Primary Outcome Measures

Delay discounting (monetary)
Discount rate, k, for delayed monetary rewards
Delay discounting (cancer recurrence)
Discount rate, k, for delayed cancer recurrence

Secondary Outcome Measures

Full Information

First Posted
June 25, 2018
Last Updated
September 30, 2019
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
Carilion Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03594578
Brief Title
Prospective Thinking in Hormone-Responsive Breast Cancer
Official Title
Effects of a Prospective Thinking Intervention on Delay Discounting in Patients With Hormone-Responsive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
Carilion Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
One factor that limits the effectiveness of adjuvant hormone therapy for breast cancer is medication nonadherence. Adherence to long-term medication regimens requires valuation of temporally distant outcomes. Thus, interventions that improve valuation of the future, a phenomenon known as delay discounting, may improve medication adherence in breast cancer treatment and improve survival. This study will investigate the acute efficacy of a prospective thinking intervention (episodic future thinking) for reducing delay discounting and improving valuation of future health in breast cancer patients. Patients will engage in either episodic future thinking or a control condition during completion of delay discounting tasks in which they choose between immediate and delayed outcomes.
Detailed Description
Globally, breast cancer is the most common cause of cancer death among women. The most common pathological subtype is hormone receptor positive breast cancer, which accounts for approximately 70% of all diagnoses. Adherence to adjuvant hormone therapy (HT), including selective estrogen receptor modulators and aromatase inhibitors, in the treatment of hormone responsive breast cancer decreases risk of recurrence and increases overall survival among women. Unfortunately, up to half of patients discontinue HT prematurely or administer HT less frequently than prescribed, which increases risk of disease recurrence and associated mortality. Understanding the mechanisms underlying nonadherence will allow for development of targeted interventions to improve breast cancer survival. A defining characteristic of adjuvant HT is that it provides no short-term benefits and, instead, prevents disease recurrence only after years of sustained adherence. In contrast, the benefits of discontinuing HT are relatively immediate (e.g., avoidance of adverse side effects, such as hot flashes or arthralgia). Thus, adherence to HT requires one's behavior to be guided by temporally distant outcomes, as bias toward immediate gratification narrows the temporal window over which future costs and benefits can motivate behavior. Therefore, treatment adherence may be understood through the behavioral economic process of delay discounting (i.e. devaluation of delayed outcomes), which provides a measure of how individuals value the future. Accumulating evidence shows that delay discounting is associated with a wide variety of maladaptive health behaviors, including failure to seek routine medical screening for cancer and other illnesses. However, no work has yet examined associations between delay discounting and adherence to cancer treatment, generally, or breast cancer treatment, specifically. This gap in knowledge represents a challenge to the understanding of risk factors for cancer-related morbidity and mortality and may limit the efficacy of breast cancer treatment. Accordingly, the present study will investigate the acute efficacy of an episodic future thinking (EFT) intervention for reducing discounting and improving valuation of future health in breast cancer patients. EFT is a form of prospection that involves mental simulation of events that might occur in one's future. To some extent, EFT is an innate human ability that guides decision-making (e.g., simulating the experience of an upcoming job interview or social event); however, populations who discount the future rapidly show deficits in this ability, considering the future infrequently and demonstrating low-quality EFT content (e.g., fewer contextual and sensory details). Thus, EFT interventions are designed to remediate this deficit and reduce bias toward immediate gratification by guiding individuals to both generate high-quality EFT content and prompting them to engage in EFT frequently. Prior laboratory-based research by the investigative team and others has shown that EFT both reduces delay discounting and improves a wide range of maladaptive health behaviors and outcomes contributing to the development of cancer and survival following diagnosis and treatment, including tobacco use and dietary and weight control. The present study seeks to extend these findings by demonstrating that EFT improves laboratory-based measures of delay discounting and valuation of future health in breast cancer patients. Demonstrating EFT's acute efficacy in the laboratory would suggest that EFT may be adapted in future grant proposals as a targeted, remotely delivered intervention to improve HT adherence and subsequent breast cancer survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Receptor Positive Malignant Neoplasm of Breast

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to either an episodic future thinking group or a control group (episodic recent thinking), stratified by menopausal status and baseline level of delay discounting.
Masking
Participant
Masking Description
Participants assigned to both groups will be masked to experimental hypotheses.
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Episodic future thinking
Arm Type
Experimental
Arm Description
Participants will complete a guided interview designed to elicit a number of personalized events that are likely to occur during various future time frames (e.g., 1 day, 1 week, 3 months, 1 year, etc.), as well as text cues designed to prompt episodic future thinking (e.g., "In 3 months, I will be at my daughter's wedding"). Text cues will be presented during subsequent behavioral tasks and participants will be asked to think vividly about these events.
Arm Title
Episodic recent thinking (control)
Arm Type
Sham Comparator
Arm Description
Participants will complete a guided interview designed to elicit a number of personalized events that occurred in the recent past (e.g., earlier today, yesterday), as well as text cues designed to prompt episodic thinking (e.g., "Earlier today, I was playing tennis with my wife."). Text cues will be presented during subsequent behavioral tasks and participants will be asked to think vividly about these events.
Intervention Type
Behavioral
Intervention Name(s)
Episodic future thinking
Intervention Description
Prospective thinking intervention
Intervention Type
Behavioral
Intervention Name(s)
Episodic recent thinking
Intervention Description
Sham episodic thinking
Primary Outcome Measure Information:
Title
Delay discounting (monetary)
Description
Discount rate, k, for delayed monetary rewards
Time Frame
1 day
Title
Delay discounting (cancer recurrence)
Description
Discount rate, k, for delayed cancer recurrence
Time Frame
1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Eligibility will be based on self-reported gender.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years Female Must have a history of hormone responsive breast cancer treated with curative intent and have been recommended/prescribed adjuvant HT (tamoxifen, anastrozole, letrozole or exemestane) by their physician. Exclusion Criteria: Recurrent breast cancer Adjuvant hormone therapy is no longer medically appropriate/advisable Incapable/ without capacity to provide personal consent Suffers from cognitive or physical impairments which interfere with medication self- administration and/or participation in episodic thinking Receiving HT for metastatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff S Stein, PhD
Organizational Affiliation
Virginia Tech Carilion School of Medicine and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Tech Carilion Research Institute
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34323542
Citation
Vaughn JE, Ammermann C, Lustberg MB, Bickel WK, Stein JS. Delay discounting and adjuvant endocrine therapy adherence in hormone receptor-positive breast cancer. Health Psychol. 2021 Jun;40(6):398-407. doi: 10.1037/hea0001077.
Results Reference
derived

Learn more about this trial

Prospective Thinking in Hormone-Responsive Breast Cancer

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