Digital Body Mindset Intervention for Young Cancer Survivors

Not Applicable

Recruiting

• Conditions: Cancer

• Registration Number: NCT06702371
• Lead Sponsor: King's College London

Brief Summary

The aim of this study is to assess whether a digital body mindset intervention - EMBody - can instil adaptive mindsets and improve health and wellbeing in young cancer survivors aged 16-25.

Detailed Description

EMBody (Exploring Mindsets about the Body) is a brief digital intervention comprising documentary-style films and reflection activities which aim to instil adaptive mindsets in young people who have previously completed cancer treatment. EMBody was co-created with young cancer survivors, paediatric oncologists with decades of clinical experience, and documentary filmmakers.

EMBody comprises three modules which include seven short films and accompanying reflection activities. The films feature young cancer survivors sharing their challenges of life after cancer and how their mindsets have supported them through these challenges. The films also feature oncology clinicians sharing their experience of the importance of mindsets in life after cancer, and psychological scientists who share information about what mindsets are and how they can be harnessed.

The main objective of the study is to assess whether a digital body mindset intervention (EMBody) can instil adaptive mindsets and improve health and wellbeing in young cancer survivors aged 16-25 years.

Researchers will compare the EMBody digital intervention with a waitlist attention control group to see if EMBody can instil adaptive mindsets and improve indicators of health and wellbeing in comparison to being enrolled in a study and completing study measures alone.

Study Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Study Start: 2024-11-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Ages 16-25 years
• Previously received a cancer diagnosis including but not limited to leukemia, Hodgkins/non-Hodgkins lymphoma, osteosarcoma, Ewing sarcoma, or CNS tumour
• Completed active, primary cancer treatment
• Are up to seven years off treatment

Exclusion Criteria

• Significant cognitive impairment that would interfere with engagement with digital materials
• Not able read or write in English
• Active suicidal intent
• Currently receiving active treatment for primary or secondary cancer
• Completed cancer treatment more than seven years ago

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	The Young Adult Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL) measure assesses four domains of HRQOL using 23 items across separate subscales of physical, social, emotional and school functioning. For all items, individuals respond on a 5-point likert scale with an amended 7 day recall period (0= never a problem, 4= almost always a problem). Higher PedsQL 4.0 scores indicate better HRQOL.

Secondary Outcome Measures

Name	Time	Method
Body Mindsets	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	The Body Mindset Inventory (BMI-2) contains items that assess different mindsets about the body, capturing both adaptive and maladaptive mindsets. For all items, individuals respond on a 6-point Likert scale (6= strongly agree, 1= strongly disagree). Higher mean scores on each mindset subscale indicate greater endorsement of that mindset.
Illness Mindsets	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	The Illness Mindset Inventory (IMI) contains 9 items that assess different mindsets about the body and about cancer, capturing both adaptive ('manageable', 'opportunity') and maladaptive ('catastrophe') mindsets. For all items, individuals respond on a 6-point Likert scale (6= strongly agree, 1= strongly disagree). Higher mean scores on each mindset subscale indicate greater endorsement of that mindset.
The Functionality Appreciation Scale	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	The Functionality Appreciation Scale (FAS) (Alleva et al, 2017) contains 7-items that capture the overall appreciation of the body's ability to function to the extent that it can. Individuals respond to items on a 5-point Likert scale (1=strongly disagree, to 5=strongly agree). A total score is created by summing items where higher scores reflect a higher appreciation for the functionality of the body.
Pain	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	Items from the The Graded Chronic Pain Scale-Revised (Von Korff et al., 2020) and the body map from the Brief Pain Inventory (Cleeland et al, 1994) will be used to assess pain, including pain interference.
Hospital Anxiety and Depression Scale	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	The Hospital Anxiety and Depression Scale (HADS) contains 14-items assessing anxiety and depression symptoms with two separate subscales, each consisting of seven items. Items are rated from 0 to 3 and subscale scores range from 0 (no distress) to 21 (maximum distress).
Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	The Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) contains 9-items assessing presence, frequency, intensity, and duration of fear of cancer recurrence thoughts and individual perceived risk of cancer recurrence. Items are rated on a 5-point likert scale and are amended to a 7 day recall period (0= not at all, 4= a great deal). Item five is reverse scored and total scores range from 0 to 36; higher scores reflect greater fear of cancer recurrence.
Post-Traumatic Growth Inventory (PTGI)	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	The Post-Traumatic Growth Inventory contains 21-items that evaluates positive changes after experiencing a stressful event such as cancer. Individuals respond on a 6-point Likert scale (0= I have not experienced this change as a result of my cancer experience - 6= I have experienced this change to a very great degree as a result of my cancer experience). A total score is created by summing all items. The scale also contains five factors and therefore separate scores can be created for each of these factors (relating to others, new possibilities, personal strength, spiritual change, appreciation of life).
Bodily Threat Monitoring Scale (BTMS)	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	The Bodily Threat Monitoring Scale (Heathcote et al, 2023) captures tendencies to monitor and appraise bodily sensations as symptomatic of something being wrong with one's body. The original scale includes 19-items, however a Short Form was used for this study. Each item is rated on a 5-point Likert scale (0= not at all like me, 4= entirely like me). Scores from items are summed and higher scores represent greater bodily threat monitoring.
Physical Activity	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	Physical activity will be captured using the Godin Leisure-Time Exercise Questionnaire (GLTEQ), which assesses physical activity throughout an individual's week based on four levels of activity intensity: strenuous, moderate, mild and sedentary. Higher scores indicate higher leisure-time physical activity.
The PedsQL Multidimensional Fatigue Scale in young adults	Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up	The PedsQL multidimensional fatigue scale captures general fatigue, sleep/rest fatigue and cognitive fatigue. This study uses the General Fatigue subscale. Respondents rate each of the 6 items on the General subscale a 5-point Likert scale ranging from 0 (never a problem) to 4 (almost always a problem). Scores are summed and higher scores indicate greater general levels of fatigue.
Global Impression of Change	Week 6 (T3)	The Global Impression of Change (GIC) contains one item will be used to evaluate a patient's overall perception of improvement or deterioration over time from taking part in the EMBody study.

Trial Locations

Locations (1)

The Royal Marsden; 🇬🇧 London, United Kingdom