The Therapeutic Effect of Expressive Writing.
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal Cornwall Hospitals Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Compassionate Expressive Writing
BehavioralA 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.
Standard Expressive Writing
BehavioralA 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Standard Expressive WritingActive comparator 1 intervention
Group B: Compassionate Expressive WritingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Self-Compassion
The Self-Compassion Scale and the Body-Compassion Questionnaire will be used to measure 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.2
Well-Being
WHO-5 (World Health Organization-Five Well-Being Index) will be used to measure 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.3
Health-related Quality of Life
The FACT-G (Functional Assessment of Cancer Therapy - General) will be used to measure 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.Secondary outcomes
1
Writing Experience
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.
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.Other outcomes
1
Pre-Intervention Data
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.
Time frame
This will be assessed at enrolment on a single occasion.2
Screening
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.
Time frame
At recruitment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Royal Cornwall Hospitals Trust
Lead sponsor
University of Plymouth
Collaborator
Source ClinicalTrials.gov