Digital Body Mindset Intervention for Young Cancer Survivors (EMBody)

King's College London

Status: Active, not recruiting

Conditions: Cancer

Treatments: Behavioral: Mindset Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06702371

324319

MRF-015-0001-RG-HEAT-C0955 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 16 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 2 patient groups

Mindset Intervention

Experimental group

Description:

Participants who are randomised to the intervention arm will complete all three modules of the EMBody intervention across six weeks. They will also complete online surveys at baseline (T0), weeks two (T1), four (T2), six (T3), 10 (T4), and 18 (T5). Data will be analysed after the T5 data collection point. There will be an additional 12-month long-term follow up (T6), with a go/no-go decision depending on trial findings; these data will be published separately.

Treatment:

Behavioral: Mindset Intervention

Waitlist Attention Control

No Intervention group

Description:

Participants randomised to the waitlist attention control arm will complete the online surveys at the same timepoints as participants randomised to the intervention arm. After the 12-month long-term follow-up survey (T6), participants in the waitlist control arm will be sent the EMBody intervention materials.