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CompletedNCT03594578Updated Oct 1, 2019

Prospective Thinking in Hormone-Responsive Breast Cancer

An interventional study of Episodic future thinking and Episodic recent thinking in Hormone Receptor Positive Malignant Neoplasm of Breast, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • Hormone Receptor Positive Malignant Neoplasm of Breast
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 89 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
89 participants (actual)

Study arms

  • 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.

    Behavioral: Episodic future thinking

  • 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.

    Behavioral: Episodic recent thinking

Interventions

  • BehavioralEpisodic future thinking

    Prospective thinking intervention

  • BehavioralEpisodic recent thinking

    Sham episodic thinking

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What researchers measure

Primary outcomes

  1. Delay discounting (monetary)

    Discount rate, k, for delayed monetary rewards

    Time frame: 1 day

  2. Delay discounting (cancer recurrence)

    Discount rate, k, for delayed cancer recurrence

    Time frame: 1 day

07

Study locations

1 site
  • Virginia Tech Carilion Research Institute
    Roanoke, Virginia 24016, United States
08

References and documents

Publications

  • 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. PubMed 34323542 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03594578
Lead sponsor
Virginia Polytechnic Institute and State University
Collaborators
Carilion Clinic
Responsible party
Jeffrey Stein (Research Assistant Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Jul 20, 2018
Start date
Aug 1, 2018
Primary completion
Sep 20, 2019
Completion
Sep 20, 2019
Last update
Oct 1, 2019

Study contacts

Jeff S Stein, PhD
principal investigator · Virginia Tech Carilion School of Medicine and Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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