Clinical trial NCT06702371: Digital Body Mindset Intervention for Young Cancer Survivors
Official title: EMBody ('Exploring Mindsets About the Body'): Harnessing Adaptive Body Mindsets to Improve Outcomes in Childhood & AYA Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Childhood Cancer
Survivors of Childhood Cancer
Mindsets
Mindset Intervention
Adolescent and Young Adult (AYA)
Wise Intervention
Body Mindsets
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Royal Marsden NHS Foundation Trust
First posted: 2024-11-22
Enrollment: 105
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated (1:1) to the EMBody intervention group or the waitlist attention control group. Those in the intervention group will complete the EMBody intervention content as well as online surveys. Those in the control group will complete the online surveys at the same time points and will receive the EMBody intervention content after their study involvement.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Secondary outcomes:
measure: Body Mindsets
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: Illness Mindsets
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: The Functionality Appreciation Scale
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: Pain
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: Hospital Anxiety and Depression Scale
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: Post-Traumatic Growth Inventory (PTGI)
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: Bodily Threat Monitoring Scale (BTMS)
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: Physical Activity
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: The PedsQL Multidimensional Fatigue Scale in young adults
timeFrame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
measure: Global Impression of Change
timeFrame: Week 6 (T3)
Other outcomes:
measure: Acceptability
timeFrame: Week 6 (T3).
measure: Adverse Events
timeFrame: Adverse Events Questions - T3 (week 6). Open Text Form - available freely to participants. PHQ9 - T0-T4 (baseline to week 10).
measure: Heart Rate Variability
timeFrame: Assessed at baseline (T0), week 6 (T3), week 10 (T4), week 18 (T5).
measure: Healthcare Usage
timeFrame: Week 6 (T3).
measure: Storytelling
timeFrame: Week 6 (T3).
measure: Qualtative Feedback
timeFrame: Week 6 (T3)
Locations:
city: London
country: United Kingdom
facility: The Royal Marsden
Study officials:
affiliation: King's College London
name: Lauren C Heathcote, PhD
role: PRINCIPAL_INVESTIGATOR
References: