~34 spots leftby Dec 2025

Writing Interventions for Breast Cancer

Recruiting in Palo Alto (17 mi)
JD
Overseen byJ. David Creswell, Ph.D.
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Carnegie Mellon University
Must be taking: Aromatase inhibitors
Disqualifiers: Implanted metal, Pregnancy, Claustrophobia, others
No Placebo Group

Trial Summary

What is the purpose of this trial?

Aromatase inhibitors are a powerful medication for reducing the risk of recurrence and increasing survival in postmenopausal breast cancer patients. However, these medications can lead to intolerable side effects, poor medication adherence, and increased stress levels. This project's broad objective is to assess whether an intervention can improve medication adherence and reduce physical symptoms and stress in breast cancer patients prescribed aromatase inhibitors. Participants will be randomly assigned to a values affirmation or reflective journaling condition. Interventions will be writing-based, one essay per month for six months. Physical symptoms and perceived stress will be assessed at baseline, post-intervention (one month after the intervention), and follow-up (six months from the post-intervention assessment and seven months after the end of the intervention). Furthermore, an electronic pill bottle will continuously assess daily compliance so that medication adherence rates during the intervention, post-intervention, and follow-up can be calculated.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it seems that participants are expected to continue taking their prescribed aromatase inhibitors during the study.

What data supports the effectiveness of the treatment Reflective Journaling, Reflective Writing, Journaling Therapy, Value Affirmation for breast cancer?

Research shows that expressive writing, a similar treatment, helped cancer patients change their thoughts about their illness, which was linked to a better quality of life. Additionally, a study on breast cancer survivors found that reflective writing allowed them to explore their feelings and concerns, suggesting potential emotional benefits.12345

Is reflective writing safe for breast cancer patients?

Reflective writing, also known as journaling, has been used safely by breast cancer patients and other cancer patients. Studies show that it can lead to positive changes in how patients think about their illness, and it is generally well-received without any reported safety concerns.12678

How does the writing intervention treatment for breast cancer differ from other treatments?

The writing intervention for breast cancer is unique because it involves expressive writing, where patients write about their cancer experiences to manage stress and improve quality of life. Unlike traditional medical treatments, this approach focuses on emotional and psychological well-being, offering a non-drug, reflective method to help patients process their feelings and potentially enhance their mental health.12459

Research Team

JD

J. David Creswell, Ph.D.

Principal Investigator

Carnegie Mellon University

JD

Janine Dutcher, Ph.D

Principal Investigator

Carnegie Mellon University

Eligibility Criteria

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).

Inclusion Criteria

Own a smartphone that can support downloaded apps
I plan to take the aromatase inhibitor as prescribed.
I have been diagnosed with breast cancer.
See 2 more

Exclusion 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).
You weigh more than 300 pounds for the brain scan part of the study.
See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete monthly writing tasks for six months, either value affirmation or reflective journaling

6 months
Monthly online or paper submissions

Post-Intervention Assessment

Assessment of physical symptoms and perceived stress one month after intervention

1 month

Follow-up

Participants are monitored for changes in stress and physical symptoms six months after post-intervention assessment

6 months

Treatment Details

Interventions

  • Reflective Journaling (Behavioral Intervention)
  • Value Affirmation (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Group I: 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.
Group II: 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.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Carnegie Mellon UniversityPittsburgh, PA
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Who Is Running the Clinical Trial?

Carnegie Mellon University

Lead Sponsor

Trials
80
Patients Recruited
540,000+

National Cancer Institute (NCI)

Collaborator

Trials
14080
Patients Recruited
41,180,000+

Findings from Research

Implementing an expressive writing study in a cancer clinic.Morgan, NP., Graves, KD., Poggi, EA., et al.[2019]
Healing through reflective writing: Breast cancer survivors' experience.Baggs, C., McKhann, L., Gessert, CE., et al.[2013]
Facilitated writing activities led by a writing coach were found to be feasible and acceptable for patients with advanced incurable cancer, with 82% of participants completing at least three months of the intervention.
The study reported no increase in anxiety or depression among participants, and most patients expressed a desire for the intervention to continue, indicating a positive reception of the writing activities.
Getting Creative: Pilot Study of a Coached Writing Intervention in Patients with Advanced Cancer at a Rural Academic Medical Center.Vergo, MT., Klassen-Landis, M., Li, Z., et al.[2022]
[Development and effectiveness of expressive writing program for women with breast cancer in Korea].Park, EY., Yi, M.[2015]
Expressive writing as a presurgical stress management intervention for breast cancer patients.de Moor, JS., Moyé, L., Low, MD., et al.[2015]
Autoethnography: reflective journaling and meditation to cope with life-threatening breast cancer.Sealy, PA.[2019]
The effects of journaling for women with newly diagnosed breast cancer.Smith, S., Anderson-Hanley, C., Langrock, A., et al.[2007]
The impact of an expressive writing intervention on quality of life among Chinese breast cancer patients undergoing chemotherapy.Lu, Q., Dong, L., Wu, IHC., et al.[2022]
The benefits of expressive writing among newly diagnosed mainland Chinese breast cancer patients.Ji, LL., Lu, Q., Wang, LJ., et al.[2022]

References

Implementing an expressive writing study in a cancer clinic. [2019]
Healing through reflective writing: Breast cancer survivors' experience. [2013]
Getting Creative: Pilot Study of a Coached Writing Intervention in Patients with Advanced Cancer at a Rural Academic Medical Center. [2022]
[Development and effectiveness of expressive writing program for women with breast cancer in Korea]. [2015]
Expressive writing as a presurgical stress management intervention for breast cancer patients. [2015]
Autoethnography: reflective journaling and meditation to cope with life-threatening breast cancer. [2019]
The effects of journaling for women with newly diagnosed breast cancer. [2007]
The impact of an expressive writing intervention on quality of life among Chinese breast cancer patients undergoing chemotherapy. [2022]
The benefits of expressive writing among newly diagnosed mainland Chinese breast cancer patients. [2022]