Digital Body Mindset Intervention for Young Cancer Survivors

NCT ID: NCT06702371

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-29

Study Completion Date

2026-10-31

Brief Summary

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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

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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.

Conditions

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Cancer

Keywords

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Childhood Cancer Survivors of Childhood Cancer Mindsets Mindset Intervention Adolescent and Young Adult (AYA) Wise Intervention Body Mindsets

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Allocation concealment is ensured through the use of Sealed Envelope, which maintains the randomisation schedule securely and prevents members of the research team responsible for enrolling participants from accessing the allocation sequence. The research team involved in data collection will not be blinded to group allocation. Members of the research team who will analyse the data will be blinded to the randomisation schedule and group allocation.

Study Groups

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Mindset Intervention

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.

Group Type EXPERIMENTAL

Mindset Intervention

Intervention Type BEHAVIORAL

The EMBody intervention contains seven short documentary-style films and paired reflection activities across three modules.

Module 1: Introducing Mindsets (Film 1: A New normal; Film 2: What is a Mindset?; Film 3: Your Body is Capable; Film 4: How to Choose Your Mindset).

Module 2: Challenges and Setbacks (Film 5: Living with Uncertainty; Film 6: The Long and Winding Road).

Module 3: Looking to the Future (Film 7: Opportunities Emerge).

Waitlist Attention Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindset Intervention

The EMBody intervention contains seven short documentary-style films and paired reflection activities across three modules.

Module 1: Introducing Mindsets (Film 1: A New normal; Film 2: What is a Mindset?; Film 3: Your Body is Capable; Film 4: How to Choose Your Mindset).

Module 2: Challenges and Setbacks (Film 5: Living with Uncertainty; Film 6: The Long and Winding Road).

Module 3: Looking to the Future (Film 7: Opportunities Emerge).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren C Heathcote, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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The Royal Marsden

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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MRF-015-0001-RG-HEAT-C0955

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

324319

Identifier Type: -

Identifier Source: org_study_id