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The Therapeutic Effect of Expressive Writing.

2026年4月28日 更新者:Royal Cornwall Hospitals Trust

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Cornwall
      • Truro、Cornwall、イギリス、TR1 3HD
        • 募集
        • Royal Cornwall Hospital NHS Trust

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Self-Compassion
時間枠: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
時間枠: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
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Writing Experience
時間枠: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.

その他の成果指標

結果測定
メジャーの説明
時間枠
Pre-Intervention Data
時間枠: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
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Ariane Scalpello、Royal Cornwall Hospital NHS Trust, University of Plymouth

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年12月22日

一次修了 (推定)

2026年5月1日

研究の完了 (推定)

2026年5月1日

試験登録日

最初に提出

2026年1月15日

QC基準を満たした最初の提出物

2026年4月28日

最初の投稿 (実際)

2026年5月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月5日

QC基準を満たした最後の更新が送信されました

2026年4月28日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2526.RCHT.44

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

IPD will be anonymised and held by the study Sponsor.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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