Prospective Thinking in Hormone-Responsive Breast Cancer

September 30, 2019 updated by: Jeffrey Stein, Virginia Polytechnic Institute and State University

Effects of a Prospective Thinking Intervention on Delay Discounting in Patients With Hormone-Responsive Breast Cancer

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Virginia Tech Carilion Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Episodic future thinking
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.
Prospective thinking intervention
Sham Comparator: Episodic recent thinking (control)
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.
Sham episodic thinking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay discounting (monetary)
Time Frame: 1 day
Discount rate, k, for delayed monetary rewards
1 day
Delay discounting (cancer recurrence)
Time Frame: 1 day
Discount rate, k, for delayed cancer recurrence
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Jeff S Stein, PhD, Virginia Tech Carilion School of Medicine and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

September 20, 2019

Study Completion (Actual)

September 20, 2019

Study Registration Dates

First Submitted

June 25, 2018

First Submitted That Met QC Criteria

July 18, 2018

First Posted (Actual)

July 20, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2574

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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