Writing Interventions for Breast Cancer

Overseen By J. David Creswell, Ph.D

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Carnegie Mellon University

Must be taking: Aromatase inhibitors

Disqualifiers: Implanted metal, Pregnancy, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if specific writing exercises can help breast cancer patients adhere to their medication more consistently and reduce stress. Participants will engage in either reflective journaling or value affirmation, writing short essays once a month for six months. The trial targets individuals diagnosed with breast cancer who are starting or planning to start aromatase inhibitors. Participants must speak English and own a smartphone.

As an unphased trial, this study offers a unique opportunity to explore personal growth and stress reduction techniques while contributing to valuable research.

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 prior data suggests that these writing interventions are safe for breast cancer patients?

Research shows that both reflective journaling and value affirmation are safe and easy activities. Reflective journaling has been used in therapy for breast cancer survivors. Participants in these studies generally found journaling positive and helpful, with no harmful effects reported. It can improve mood and reduce stress by allowing expression of thoughts and feelings.

Value affirmation is also safe. Studies suggest it can increase optimism and positive feelings among cancer survivors. By focusing on personal values, individuals often feel less stressed and experience better emotional health. No negative side effects have been reported from value affirmation exercises.

Overall, both activities are non-invasive, meaning they don't involve any physical procedures or medications. This makes them low-risk options for supporting health and well-being during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these writing interventions for breast cancer because they offer a unique, non-pharmacological approach to supporting patients' mental well-being. Reflective Journaling encourages participants to engage with perspectives outside their immediate values, potentially broadening their worldview and providing a sense of connection with others. Value Affirmation, on the other hand, focuses on reinforcing personal values, which can help boost self-esteem and resilience during treatment. Unlike traditional treatments like chemotherapy or hormone therapy, these interventions are simple and accessible, requiring only ten minutes of writing per session, and can be easily integrated into daily life.

What evidence suggests that these writing interventions could be effective for improving medication adherence and reducing stress in breast cancer patients?

This trial will compare two writing interventions for breast cancer patients: reflective journaling and value affirmation. Research has shown that reflective journaling can improve quality of life and reduce stress, tiredness, and anxiety. Participants in this trial may engage in reflective journaling, which involves writing about values that are not important to them and discussing why these values could be important to others. In contrast, value affirmation has been linked to fewer physical symptoms and less distress in breast cancer survivors. Participants may also engage in value affirmation, focusing on personal values to increase optimism and improve mental well-being. Both methods offer promising ways to help breast cancer patients manage their symptoms and stress. ^{1 2 4 6 7}

Who Is on the Research Team?

J. David Creswell, Ph.D.

Principal Investigator

Carnegie Mellon University

Janine Dutcher, Ph.D

Principal Investigator

Carnegie Mellon University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Reflective Journaling
• Value Affirmation

Trial Overview

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.

How Is the Trial Designed?

Group I: Reflective Journaling Active Control 1 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 Affirmation Active Control 1 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.

Who Is Running the Clinical Trial?

Carnegie Mellon University

Lead Sponsor

Trials

80

Recruited

540,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A study involving 71 adult leukemia and lymphoma patients showed that a 20-minute expressive writing task was feasible and well-received in a clinical setting, with 88% of participants completing the task.

Participants reported positive changes in their thoughts about their illness, which were significantly associated with improved physical quality of life at a 3-week follow-up, suggesting that even brief writing exercises can enhance well-being in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing an expressive writing study in a cancer clinic. Morgan, NP., Graves, KD., Poggi, EA., et al.[2019]

The expressive writing program developed for women with breast cancer significantly reduced stress related to physical symptoms and improved quality of life, as shown by a study involving 58 participants (29 in the experimental group and 29 in the control group).

While the program was effective in alleviating physical symptoms and enhancing quality of life, it did not show significant effects on cancer symptoms, anxiety, or depression, indicating a need for further research to explore its impact on emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development and effectiveness of expressive writing program for women with breast cancer in Korea]. Park, EY., Yi, M.[2015]

Reflective journaling and meditation can be effective coping strategies for individuals dealing with locally advanced breast cancer, helping to address unresolved emotional issues that may complicate treatment and recovery.

The process of re-experiencing past emotional wounds through meditation can lead to greater self-acceptance and empowerment, ultimately improving quality of life by transforming loss and grief into a source of strength and meaning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autoethnography: reflective journaling and meditation to cope with life-threatening breast cancer. Sealy, PA.[2019]

A study involving 90 Chinese breast cancer survivors showed that expressive writing interventions, particularly writing about cancer facts, significantly improved quality of life (QOL) compared to writing about stress and coping efforts.

Writing about positive aspects of the cancer experience also improved QOL, but not as effectively as writing about cancer facts, indicating that both approaches can be beneficial for patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 Journal of My Medical Experiences intervention involved 107 breast cancer survivors engaging in reflective writing over six weeks, providing a safe online space for emotional expression.

Participants reported exploring various themes related to their feelings and concerns, with about half actively posting their writings, suggesting that reflective writing can be a valuable tool for emotional support in cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing through reflective writing: Breast cancer survivors' experience. Baggs, C., McKhann, L., Gessert, CE., et al.[2013]

A study involving 118 mainland Chinese breast cancer patients found that expressive writing interventions significantly improved quality of life (QoL) over 6 months, particularly for those in the cancer-facts and emotional disclosure writing groups compared to a neutral control group.

The emotional disclosure writing group reported the highest QoL, while the cancer-facts group showed better physical well-being than the self-regulation writing group, highlighting the varying effectiveness of writing interventions based on the type of writing and the patients' cultural context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits of expressive writing among newly diagnosed mainland Chinese breast cancer patients. Ji, LL., Lu, Q., Wang, LJ., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Expressive writing (EW) did not significantly reduce distress, perceived stress, sleep disturbance, or pain in breast cancer patients undergoing treatment, based on a study of 49 women who participated in four writing sessions over a week.

The effectiveness of EW varied with social constraints; women with high social constraints reported lower pain levels with EW, while those with low social constraints experienced higher pain levels, indicating that EW may not be a universally effective stress management strategy for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expressive writing as a presurgical stress management intervention for breast cancer patients. de Moor, JS., Moyé, L., Low, MD., et al.[2015]

In a study of 43 women newly diagnosed with breast cancer, higher levels of negative emotion expressed in expressive journal writing were linked to increased anxiety and depression after a 12-week support group, indicating that the content of their writing can impact their mood.

The study suggests that focusing on the expression of negative emotions in journaling may be important for mental health, highlighting the need for further research to develop effective journaling recommendations for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of journaling for women with newly diagnosed breast cancer. Smith, S., Anderson-Hanley, C., Langrock, A., et al.[2007]

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The results of this study suggest that gratitude journaling is an effective intervention to enhance the QoL of patients with breast cancer.

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Writing Interventions in Breast Cancer Patients Taking ...

This project's broad objective is to assess whether an intervention can improve medication adherence and reduce physical symptoms and stress in breast cancer ...

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Background: People living with and beyond breast cancer can face internal barriers to physical activity (eg, fatigue and pain).