- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07567157
The Therapeutic Effect of Expressive Writing.
The Therapeutic Effect of Expressive Writing in People Living With and Beyond Cancer.
The goal of this clinical trial is to understand the impact of compassionate expressive writing in people living with and beyond cancer. The main question it aims to answer is:
Does compassionate expressive writing have any impact on well-being outcomes in people living with and beyond cancer, such as body compassion, self-compassion, quality of life and psychological well-being outcomes ?
Researchers will compare compassionate expressive writing with a standard expressive writing task (with no compassionate prompt) to see if there is a difference in self-reported body compassion, self-compassion, quality of life and psychological well-being outcomes between the two conditions.
Participants will :
Complete a series of pre-intervention questionnaires. Be assigned to one of the two writing conditions. Attend four expressive writing sessions and write freely for approximately 20 minutes in response to a topic related to their cancer experience.
Complete a series of post-intervention questionnaires. Repeat the questionnaires at 1-month follow-up.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
Body-Compassion
A particular focus of this research is to further contribute towards an understanding of body-compassion. While many studies have explored the concepts of body image and self-compassion with people who have a cancer diagnosis, there is limited research exploring the concept of body compassion with this population. As a construct that has only recently been formally defined, body compassion reflects the aspects of kindness, human connectedness, and mindfulness toward the body. Self-compassion is seen to promote body compassion, which, in turn, acts as a buffer against distressing events that threaten one's body image. The growing interest in this concept has led to the development and validation of body compassion measures. The 'Body Compassion Scale' developed by pioneered the development of a measure of body compassion. This scale was followed by the development and validation of 'The Body Compassion Questionnaire'. The concept of compassion directed towards the body seems highly salient for people with cancer. It would be worth building on current evidence about the role of body compassion in cancer by utilising body-compassion measures to further understand this construct and the experience of having cancer-related body change.
Compassion-based interventions
Over the past two decades, there has been a growing interest in developing evidence-based interventions to support people individually and in groups to foster a sense of compassion (Kirby & Gilbert, 2017). Compassion-focused Therapy (CFT), developed by Gilbert (2014), and Mindful Self-Compassion by Neff and Germer (2013), are two approaches that apply the importance of facing one's suffering with the motivation to take action to reduce this suffering through self-soothing techniques. These psychological approaches include interventions to support the development of the compassionate self through imagery, breathing exercises, mindfulness, and letter writing. A compassion-focused model applies a compassionate approach to regular psychotherapy, allowing the relatively unrestricted incorporation of compassion-based interventions in clinical practice (Kirby, 2017). Group interventions have built on the CFT framework to reduce self-criticism and foster self-compassion (Kirby et al., 2017). A number of randomised control trial (RCT) studies involving such interventions indicate clinical improvements and a sustained increase in self-compassion (Arimitsu, 2016; Braehler et al., 2013). RCT studies with cancer patients have also yielded promising evidence related to mindfulness and compassion-focused interventions within a clinical setting (O'Gara et al., 2022; Tan et al., 2023)
Expressive Writing
The interest in mindfulness and self-compassion in clinical psychology is also linked with the development of expressive writing (EW) by psychologist Pennebaker in the 1980s (Adams, 2013; Lam, 2024). EW offers a simple, cost-effective means of experiencing the therapeutic effects of writing one's thoughts and feelings (Kupeli et al., 2019). The theories underpinning the effects of EW suggest that the uninhibited confrontation of thoughts surrounding a traumatic life event allows for the reappraisal of the event, reduction in rumination, and an opportunity to gain mastery and control over negative emotions associated with the experience (Lepore et al., 2002; Lowe, 2006). As a result, research has shown that EW can improve physical and psychological health outcomes in clinical populations (Frisina et al., 2004).
Some studies have been interested in understanding how a writing exercise such as EW can be adapted to promote self-compassion and potentially increase the therapeutic benefits of EW (Baum & Rude, 2013; Kalianivala, 2019). In one study, Compassion-focused EW demonstrated a reduction in negative affect in an experimental study with people writing about stress (Leary et al., 2007). It has also promoted increased self-reported self-esteem and self-soothing in a clinical sample within a hospice setting (Imrie & Troop, 2012). Such research demonstrates the versatility and the potential benefit of incorporating self-compassionate EW in clinical practice as a supplementary tool with individuals and groups (Lam, 2024). Moreover, evidence indicates that cancer patients can benefit from compassionate EW (Przezdziecki et al., 2013).
The use of Language
The impact of EW can be explored using outcome measures, but it can also be further enhanced by analysing writing scripts. The writing content provides meaningful insight into factors that could contribute to perceptions of the body and the cancer experience (Kaptein et al., 2024). Writing texts can be analysed manually, but such a process would take time and can be subjective. Computerised software such as the Linguistic Inquiry and Word Count (LIWC) provides a more efficient and objective method of analysing linguistic content (McDonnell et al., 2020; Pennebaker et al., 2001). Some word categories within the LIWC include linguistic dimensions such as personal pronouns and prepositions, emotion words, and cognitive words (Boyd et al., 2022). A PubMed search by Kaptein et al. (2024) indicated 17 studies that utilised the LIWC methodology with a cancer population. Most of these studies analysed text to make inferences on the impact of interventions on the number of particular words used and effects on health outcomes (Laccetti, 2007; Martino, 2015). Such aspects provide meaningful insight and are worth exploring further in new research. Moreover, it is important to shed further light on people's experiences of embedded writing tasks such as EW within the context of local support services.
The Clinical Application of this Study
One way of exploring the feasibility of incorporating a compassionate writing intervention into clinical practice is to test whether it could be facilitated within a community cancer clinic. Shifting from clinical trials toward community-based contexts provides an opportunity to test the benefit and applicability of research evidence within clinical care. One example is demonstrated by Morgan et al. (2008), who explored the feasibility of incorporating an EW programme into the existing care provision at a cancer centre in the USA. The Cove Macmillan Cancer Support Centre is a local cancer service that offers a range of physical and psychosocial support for people with cancer and their carers. The Cove also offers psychological therapy and support groups for patients in Cornwall. Piloting an EW intervention within this setting allows a local service to collaborate in research and encourages patients' perspectives on their care and support provision at the Cove. This research explores some relatively novel aspects of cancer patients' experiences and contributes to research that can potentially improve patients' physical and psychological health outcomes.
Rationale
Cancer and its treatment can profoundly impact people's lives, especially if they result in permanent changes to the body. Changes to the body's appearance, function, and internal composition affect a person's day-to-day life and cognitive and emotional perceptions of the self (Melissant et al., 2020). Current evidence indicates that compassionate skills can mitigate the adverse emotional effects of events like cancer (Oliveira et al., 2018). Compassion towards the self involves recognising suffering as part of the human condition while seeking to improve this and heal. Research indicates that mindfulness practices, such as expressive writing, can encourage compassionate thinking towards oneself. It is noted that current evidence tends to focus on the role of self-compassion in the context of cancer-related changes in appearance. Alternatively, research exploring the impact of internal body changes on compassion towards the self and the body is limited (Arambasic et al., 2019; Przezdziecki et al., 2013; Todorov et al., 2019). This gap in research has prompted me to explore compassionate thinking in those who have experienced cancer-related changes to their appearance, as well as bodily changes that are less visible but impact functionality and quality of life. This study also aims to conduct a randomised controlled trial to test whether there is a difference in compassion and well-being outcomes between those who complete regular expressive writing and those who complete an expressive writing task that includes a compassionate writing prompt.
Study Design
This project will utilise a quantitative methodology by collecting and analysing questionnaires, standardised outcome measures, and writing scripts. This study will follow a randomised control trial (RCT) design within a heterogeneous cancer patient population. Participants will be randomly allocated either to a writing group with a compassionate writing prompt or to a control writing group with no compassionate prompt. This project will be designed as a pragmatic RCT as it aims to provide information on the feasibility and acceptability of such an intervention at one cancer support site.
Study Procedure
At least 46 participants will be recruited using volunteer and opportunity sampling methods with the support of the staff team at the Cove Macmillan Support Centre. The field supervisor of this project, who is the Clinical Lead of the Psychology Service at the Cove, together with members of the multi-disciplinary team at the Cove (support workers, counsellors, occupational therapists) will support recruitment by directing those who express interest to the Chief Investigator (CI) for more information and study materials (Informed Consent Form (ICF) & Participant Information Sheet (PIS).
Consent will be gained in person at the Cove or recorded over the phone with those who make contact to volunteer. Once a sufficient sample size is recruited and written consent is acquired, participants will be asked to complete the screening questionnaire (Impact of Events Scale) to confirm their eligibility. Using a computerised random number generator, participants will then be randomly assigned to a compassionate or control writing group.
Prior to commencing the first writing task, participants will complete the pre-writing task questionnaire to gather demographic and medical information and information on previous writing experience. Participants will also be asked to complete standardised measures of body compassion, self-compassion, quality of life and psychological well-being before their first writing task.
Following service user feedback shared with the CI, participants will be given the choice to either attend an in-person group writing task at the Cove Macmillan Centre or they can participate remotely via an online communication platform (e.g., Microsoft Teams or Zoom). Participants will be blinded to the study conditions and invited to attend only one of the two weekly writing groups at the Cove or online for four consecutive weeks, according to their allocated writing conditions. As the primary researcher cannot be blinded to the study conditions, a script will be followed to minimise researcher bias when introducing the study and stating writing instructions.
The writing task will be introduced to participants attending each writing session, advising them to limit distractions and to write freely without focusing on structure, grammar, or spelling (Elbow, 1998). Participants attending the Cove will be provided with the necessary writing materials. A topic will be selected by the researcher for each writing session. Such topics may include reflections on participants' past, present, and future selves, their feelings about their bodies, the impact of their treatment journey on their relationships, and their values. Participants in both writing groups will be asked to write about a topic for 15-20 minutes. In the compassionate writing group, participants will be encouraged to maintain compassion towards themselves and their experiences while writing. Participants in the control writing condition will be given the same instructions, but with no reminder about being compassionate.
Upon completion of each writing task, participants will be asked to hand in their writing scripts and complete the post-writing task questionnaire to gather subjective information about their writing task experience. This process will be repeated after each of the four writing sessions. Participants will only be asked to repeat the standardised measures following their final writing task.
At one-month follow-up after study completion, participants will be contacted to complete the follow-up questionnaire and repeat the standardised outcome measures. Participants will be provided with various options for completing the questionnaires and outcome measures, from the screening stage through to follow-up. These include completing paper versions in person at the Cove, remotely over the phone or through online access using the University of Plymouth-approved platform Jisc. A debrief sheet will also be provided once the study is completed, to clarify the study conditions and the rationale for the procedure and provide signposting for further support if needed. Participants will be provided with this sheet via email and offered the opportunity to discuss or ask further questions to the CI. Participants will also be asked whether they wish to receive study results and will be directed to the Cove team for any further support needed as a result of their participation in the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ariane Scalpello, Doctoral
- Phone Number: +44 7538158711
- Email: ariane.scalpello@plymouth.ac.uk
Study Contact Backup
- Name: RCHT Sponsor RCHT Sponsor
- Phone Number: 01872 25 5117
- Email: rcht.sponsor@nhs.net
Study Locations
-
-
Cornwall
-
Truro, Cornwall, United Kingdom, TR1 3HD
- Recruiting
- Royal Cornwall Hospital NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To have experienced an internal or external change to their body due to any form of cancer and/or its treatment at any point in their lives.
- To be 18 or older.
- The ability to read and write in English.
- To have the ability to provide informed consent.
Exclusion Criteria:
- Distress levels that make participation safe or inappropriate due to cancer prognosis or a mental health condition. (This is flagged by the score on the IES questionnaire.)
- Inability to realistically commit to a 4-week intervention due to poor physical or mental health or other personal commitments.
- Inability to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Expressive Writing
A standard expressive writing condition that will follow the same topic and process as the experimental writing condition but will not include a compassionate writing prompt.
|
A 20-minute practitioner-led expressive writing session that involves the practitioner introducing a topic related to cancer such as, the impact of diagnosis/treatment on relationships with others, with ones body, with the world.
Participants are not prompted to think compassionately in this condition but allowed to write freely about the topic without further structure.
|
|
Experimental: Compassionate Expressive Writing
An expressive writing condition that will include a compassionate prompt at the start that will encourage participants to be compassionate towards themselves and their experiences when writing.
|
A 20-minute practitioner-led expressive writing session that involves the practitioner introducing a topic related to cancer such as, the impact of diagnosis/treatment on relationships with others, with ones body, with the world.
Participants are encouraged to write freely and are prompted to remain compassionate towards themselves and their experience at the start of the writing session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion
Time Frame: Assessment of change between the first writing session and the final writing session 4 weeks later and then again at 1 month following the completion of the final session. Assessed for a duration of 8 weeks.
|
The Self-Compassion Scale and the Body-Compassion Questionnaire will be used to measure self-compassion.
|
Assessment of change between the first writing session and the final writing session 4 weeks later and then again at 1 month following the completion of the final session. Assessed for a duration of 8 weeks.
|
|
Well-Being
Time Frame: Assessment of change between the first writing session and the final writing session 4 weeks later and then again at 1 month following the completion of the final session. Assessed for a duration of 8 weeks.
|
WHO-5 (World Health Organization-Five Well-Being Index) will be used to measure well-being.
|
Assessment of change between the first writing session and the final writing session 4 weeks later and then again at 1 month following the completion of the final session. Assessed for a duration of 8 weeks.
|
|
Health-related Quality of Life
Time Frame: Assessment of change between the first writing session and the final writing session 4 weeks later and then again at 1 month following the completion of the final session. Assessed for a duration of 8 weeks.
|
The FACT-G (Functional Assessment of Cancer Therapy - General) will be used to measure quality of life.
|
Assessment of change between the first writing session and the final writing session 4 weeks later and then again at 1 month following the completion of the final session. Assessed for a duration of 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Writing Experience
Time Frame: Assessed at the end of each of the four writing session, and again at one month following the completion of the final writing session. Assessed over 8 weeks.
|
Feasibility of facilitating an expressive writing group at the Cove Macmillan Support Centre is a secondary outcome of this study.
This will be measured using the post-writing task questionnaire to assess participants self-reported experience of each writing task.
|
Assessed at the end of each of the four writing session, and again at one month following the completion of the final writing session. Assessed over 8 weeks.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pre-Intervention Data
Time Frame: This will be assessed at enrolment on a single occasion.
|
A self-report questionnaire will be developed for this study to gather information regarding participant demographics, medical details, and previous writing experience. A draft version is provided in. The pre-writing task questionnaire structure and data collection process will be formalised with patient/service user involvement. Demographic data about age, gender, and educational level will be collected. Medical data regarding participants' cancer diagnosis and treatment, including age, gender, and educational level, will also be requested. Participants will also be asked to rank their self-reported writing frequency and skills on a 5-point Likert scale. |
This will be assessed at enrolment on a single occasion.
|
|
Screening
Time Frame: At recruitment.
|
The Impact of Events Scale (IES) is a reliable and valid instrument for measuring cancer-related distress (Horowitz et al., 1979).
The IES will be used as a screening tool and as a component of the eligibility criteria to ascertain their current levels of distress regarding the impact of cancer and its treatment.
This measure is in place to ensure the well-being of participants and to minimise potential harm.
If a participant scores above the cut-off of 24 on the IES (Horowitz et al., 1979), there is a strong indication that the participant is experiencing moderate to high levels of post-traumatic stress as a result of their cancer experience.
|
At recruitment.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ariane Scalpello, Royal Cornwall Hospital NHS Trust, University of Plymouth
Publications and helpful links
General Publications
- Altman JK, Linfield K, Salmon PG, Beacham AO. The body compassion scale: Development and initial validation. J Health Psychol. 2020 Mar;25(4):439-449. doi: 10.1177/1359105317718924. Epub 2017 Jul 12.
- Oliveira S, Trindade IA, Ferreira C. The buffer effect of body compassion on the association between shame and body and eating difficulties. Appetite. 2018 Jun 1;125:118-123. doi: 10.1016/j.appet.2018.01.031. Epub 2018 Feb 7.
- Beadle ES, Cain A, Akhtar S, Lennox J, McGuire L, Troop NA. Development and validation of the Body Compassion Questionnaire. Health Psychol Behav Med. 2021 Nov 21;9(1):951-988. doi: 10.1080/21642850.2021.1993229. eCollection 2021.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2526.RCHT.44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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