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Writing Interventions for Breast Cancer
N/A
Recruiting
Led By J. David Creswell, Ph.D
Research Sponsored by Carnegie Mellon University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intention to take the prescribed aromatase inhibitor
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in adherence assessed daily, throughout 1-year participation in the study
Awards & highlights
Study Summary
This trial is investigating whether an intervention can improve medication adherence and reduce physical symptoms and stress in postmenopausal breast cancer patients prescribed aromatase inhibitors.
Who is the study for?
This trial is for postmenopausal breast cancer patients who plan to take aromatase inhibitors, can read and write in English, have a smartphone for app use, and are either currently prescribed or will be prescribed the medication within four weeks. It's not for those with claustrophobia, metal implants, electronic medical devices, current pregnancy, weight over 300 pounds or a metal-containing IUD (specifically for fMRI part of the study).Check my eligibility
What is being tested?
The study tests if writing interventions like values affirmation or reflective journaling can help women taking aromatase inhibitors stick to their medication schedule while reducing stress and physical discomfort. Participants will write one essay per month over six months with assessments at various stages.See study design
What are the potential side effects?
While this trial focuses on writing exercises that don't have direct side effects like drugs do, participants may experience emotional distress related to reflecting on personal values or their illness during the intervention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I plan to take the aromatase inhibitor as prescribed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in adherence assessed daily, throughout 1-year participation in the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in adherence assessed daily, throughout 1-year participation in the study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Bodily Pain as assessed by the RAND 36-Item Health Survey 1.0
Change in Medication Adherence
Change in Perceived Stress
+7 moreSecondary outcome measures
Change in Depression Severity
Change in Engagement of Enjoyable Activities as assessed by the Pittsburgh Enjoyable Activities Test
Change in Gratitude
+9 moreTrial Design
2Treatment groups
Active Control
Group I: Value AffirmationActive Control1 Intervention
Participants in the value affirmation condition will complete six writing prompts regarding their personal values over the course of six months. For example, participants will be given a list of values and will be asked to rate them in order of importance within their own lives and write about a time when their top value was particularly important. Participants will write for about ten minutes each session. The intervention tasks will be completed on a secure, online website that each individual participant will be emailed a link to. Participants can also receive paper copies via postal mail if they prefer.
Group II: Reflective JournalingActive Control1 Intervention
Participants in the reflective journaling condition will complete six writing prompts over the course of six months. However, the reflective journaling condition will be writing about values that are not important to them and discuss why they could be important to others. In other tasks, they will write about aspects of daily life (e.g. morning routine). Participants will write for about ten minutes each session. The intervention tasks will be completed on a secure, online website that each individual participant will be emailed a link to. Participants can also receive paper copies via postal mail if they prefer.
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Who is running the clinical trial?
Carnegie Mellon UniversityLead Sponsor
76 Previous Clinical Trials
539,680 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,604 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,110 Patients Enrolled for Breast Cancer
Janine Dutcher, Ph.DStudy DirectorCarnegie Mellon University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have metal implants in your body (for fMRI testing only).You have felt very scared in small, enclosed spaces in the past (for the MRI scan part only).I plan to take the aromatase inhibitor as prescribed.You weigh more than 300 pounds for the brain scan part of the study.I have been diagnosed with breast cancer.You have a specific type of intrauterine device (IUD) with metal, but this only matters for the fMRI part of the study.I have been or will be prescribed an aromatase inhibitor soon.
Research Study Groups:
This trial has the following groups:- Group 1: Value Affirmation
- Group 2: Reflective Journaling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current headcount of participants in this clinical investigation?
"Affirmative. Clinicaltrials.gov has data that confirms this medical experiment, which was first posted on February 1st 2021, is recruiting participants presently. 250 subjects are needed to be enrolled at a single location."
Answered by AI
Are researchers currently recruiting for this investigation?
"The details of this clinical trial, which were initially published on February 1st 2021, are currently being actively advertised. The entries have been recently amended as recenty as September 30th 2022."
Answered by AI
What are the primary goals of this research study?
"This medical trial will evaluate the change in physical symptoms after a single session of intervention, with secondary outcomes measuring changes in depression severity (as determined by the Patient Health Questionnaire), recovery from stress (measured through the Brief Resilience Scale) and well-being (assessed using The Mental health Continuum Short Form for Adults)."
Answered by AI
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