NCT07567157

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

January 15, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Self-CompassionExpressive WritingCancer

Outcome Measures

Primary Outcomes (3)

  • Self-Compassion

    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

    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

    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 Outcomes (1)

  • Writing Experience

    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 Outcomes (2)

  • Pre-Intervention Data

    This will be assessed at enrolment on a single occasion.

  • Screening

    At recruitment.

Study Arms (2)

Standard Expressive Writing

ACTIVE COMPARATOR

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.

Behavioral: Standard Expressive Writing

Compassionate Expressive Writing

EXPERIMENTAL

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.

Behavioral: Compassionate Expressive Writing

Interventions

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.

Compassionate Expressive 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 not prompted to think compassionately in this condition but allowed to write freely about the topic without further structure.

Standard Expressive Writing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Cornwall Hospital NHS Trust

Truro, Cornwall, TR1 3HD, United Kingdom

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28810491BACKGROUND
  • 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.

    PMID: 29427690BACKGROUND
  • 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.

    PMID: 34868737BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ariane Scalpello

    Royal Cornwall Hospital NHS Trust, University of Plymouth

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariane Scalpello, Doctoral

CONTACT

RCHT Sponsor RCHT Sponsor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

May 5, 2026

Study Start

December 22, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

IPD will be anonymised and held by the study Sponsor.

Locations