Prospective Thinking in Hormone-Responsive Breast Cancer

NCT03594578 | Completed

• 1 other identifier: 2574
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone Receptor Positive Malignant Neoplasm of Breast

Outcome Measures

Primary Outcomes (2)

• Delay discounting (monetary)

  Discount rate, k, for delayed monetary rewards

  1 day

• Delay discounting (cancer recurrence)

  Discount rate, k, for delayed cancer recurrence

  1 day

Study Arms (2)

Episodic future thinking

EXPERIMENTAL

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

Episodic recent thinking (control)

SHAM COMPARATOR

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

Episodic future thinking BEHAVIORAL

Prospective thinking intervention

Episodic future thinking

Episodic recent thinking BEHAVIORAL

Sham episodic thinking

Episodic recent thinking (control)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Eligibility will be based on self-reported gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Carilion Clinic: collaborator

Study Sites (1)

Virginia Tech Carilion Research Institute

Roanoke, Virginia, 24016, United States

Location

Related Publications (1)

• 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.

  PMID: 34323542 DERIVED

Study Officials

• Jeff S Stein, PhD

  Virginia Tech Carilion School of Medicine and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants assigned to both groups will be masked to experimental hypotheses.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 20, 2018
• Study Start: August 1, 2018
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)