RecruitingACTRN12619001693112

Kind to my Body: A study of feelings towards your body in women with Breast Cancer

A Randomised Control Trial of a Self-Compassion Writing and Meditation Intervention to assess effect on Body Image Distress in Women with Breast Cancer


Sponsor

Macquarie University

Enrollment

225 participants

Start Date

Mar 17, 2020

Study Type

Interventional

Conditions

Summary

The purpose of the study is to evaluate whether a brief self-compassion based writing exercise, known as 'My Changed Body' (MyCB), can alleviate body image distress (BID) in women recently diagnosed with breast cancer, over and above and expressive writing alone. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have been previously diagnosed with Stage I-III breast cancer and/or ductal carcinoma in-situ and undergone breast cancer-related surgery within the last 2 years Study details All participants will be randomly assigned (by chance) to one of three groups. One intervention group will focus on an online writing tool only, i.e 'MyCb', where participants will focus on self-compassion strategies over two writing sessions. The second intervention will also involve the MyCB writing tool plus a daily meditation component. The third group (control) will participate in an expressive writing activity. All participants will be asked to complete questionnaires about their body image. It is anticipated that MyCB plus meditation intervention can reduce body image distress and assist in maintaining a positive self image for longer. In addition, we hope to provide greater insight into psychological strategies that may help women with breast cancer.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

A breast cancer diagnosis and the surgery that follows can change the way you feel about your body in ways that are hard to put into words — scars, changes in shape, loss of sensation. This study is exploring whether a short online writing exercise called 'My Changed Body' (MyCB) can help women feel better about their bodies after breast cancer surgery. MyCB guides you through two writing sessions focused on self-compassion, helping you acknowledge and accept the changes your body has been through. Women who join will be randomly placed into one of three groups: one group uses the MyCB writing tool on its own, a second group uses MyCB together with a daily short meditation, and a third group does a more general expressive writing exercise as a comparison. All groups complete questionnaires about how they feel about their bodies before and after the program. You may be eligible if you are a woman aged 18 or older who was diagnosed with Stage I–III breast cancer or ductal carcinoma in situ within the last two years and have had breast cancer–related surgery. You should also have had at least one experience — like feeling embarrassed or sad — linked to changes in your body since your diagnosis.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The project design is a three-group blind randomised controlled designed with two intervention groups: • Group 1: My Changed Body Writing (MyCB) • Group 2: My Changed Body Writing plus meditation (M

The project design is a three-group blind randomised controlled designed with two intervention groups: • Group 1: My Changed Body Writing (MyCB) • Group 2: My Changed Body Writing plus meditation (MyCB + Meditation) All writing activities and study questionnaires will be completed online via the secure Qualtrics portal run through Macquarie University with no direction from personnel. Meditations will be downloadable from the Qualtrics portal and via participant emails (for those in group 2 only). The My Changed Body is an evidence-based web-based writing intervention designed to address body image concerns arising from breast cancer surgery and treatment (Sherman et al., 2018). Participants in both of the MyCB writing condition will complete the condition over two sessions, directly following the baseline and 1 month survey. Participant reminder emails will be sent to ensure adherance. The first session will be conducted directly after completing the baseline questionnaires and entails the complete MyCB activity, which is a self-paced writing activity that is estimated to take approximately 30 min to complete. Six writing prompts are provided: (1) an introductory unstructured writing section where individuals write about a negative body image experience according to a modified Pennebaker (Pennebaker & Seagal, 1999) writing prompt; (2) treatment of one’s body with kindness; (3) kind advice to oneself; (4) connection with others who experience difficulties with body image; (5) awareness of one’s circumstances and reactions in a broader context; and, (6) a self-compassionate letter to the writer that acts as a summary of the most salient points of self-compassion as applied to one’s own situation. Thus, the intervention user addresses self-kindness, common humanity and mindful awareness, as outlined by self-compassion research. The second session will be conducted directly following the 1-month follow-up questionnaires and entail participants completing a brief version of the MyCB writing activity, which will take approximately 10min. Participants will be asked to repeat only step 6 of the writing process, which is to write a self-compassionate letter to themselves. In addition to the protocol outlined above for Group #1 Intervention, participants in Group #2 will complete meditations over two-time periods. Firstly, following the final baseline questionnaires, participants will be provided a link to download an audio file of a self-compassion based meditation. The meditation will also be emailed to their nominated account. The 5 minute meditation can be saved to the mobile or digital device. Participants will be instructed to listen to the meditation either sitting or laying down, in a quiet and uninterrupted space, each day, for the following three weeks. To maximise compliance, participants will receive a daily SMS reminder to listen to the audio recording. Upon completion of the 1-month questionnaires and MyCB writing activity, participants will be asked to listen to the same meditation either sitting or lying down, in a quiet and uninterrupted space, each day, for the following three weeks. To maximise compliance, participants will receive a daily SMS reminder to listen to the audio recording.


Locations(4)

All, New Zealand

All, Canada

All, United Kingdom

All, United States of America

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ACTRN12619001693112


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