ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Thinking in Hormone-Responsive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03594578
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Carilion Clinic
Information provided by (Responsible Party):
Virginia Polytechnic Institute and State University

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.

Condition or disease Intervention/treatment Phase
Hormone Receptor Positive Malignant Neoplasm of Breast Behavioral: Episodic future thinking Behavioral: Episodic recent thinking Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Masking Description: Participants assigned to both groups will be masked to experimental hypotheses.
Primary Purpose: Basic Science
Official Title: Effects of a Prospective Thinking Intervention on Delay Discounting in Patients With Hormone-Responsive Breast Cancer
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: Episodic future thinking
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.
Behavioral: Episodic recent thinking
Sham episodic thinking




Primary Outcome Measures :
  1. Delay discounting (monetary) [ Time Frame: 1 day ]
    Discount rate, k, for delayed monetary rewards

  2. Delay discounting (cancer recurrence) [ Time Frame: 1 day ]
    Discount rate, k, for delayed cancer recurrence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility will be based on self-reported gender.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594578


Contacts
Contact: Jeff S Stein, PhD 540-526-2124 jstein1@vtc.vt.edu
Contact: Jennifer E Vaughn, MD jvaughn@vtc.vt.edu

Locations
United States, Virginia
Virginia Tech Carilion Research Institute Recruiting
Roanoke, Virginia, United States, 24016
Contact: Jeff Stein, Ph.D.    540-526-2124    jstein1@vtc.vt.edu   
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Carilion Clinic
Investigators
Principal Investigator: Jeff S Stein, PhD Virginia Tech Carilion Research Institute

Responsible Party: Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT03594578     History of Changes
Other Study ID Numbers: 2574
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs