Digital Body Mindset Intervention for Young Cancer Survivors

NCT06702371 | Active Not Recruiting

• 2 other identifiers: 324319MRF-015-0001-RG-HEAT-C0955
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life

  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.

  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 (11)

• 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

• 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 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

• Pain

  Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up

• 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

Other Outcomes (6)

• Acceptability

  Week 6 (T3).

• Adverse Events

  Adverse Events Questions - T3 (week 6). Open Text Form - available freely to participants. PHQ9 - T0-T4 (baseline to week 10).

• Heart Rate Variability

  Assessed at baseline (T0), week 6 (T3), week 10 (T4), week 18 (T5).

Study Arms (2)

Mindset Intervention

EXPERIMENTAL

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.

Behavioral: Mindset Intervention

Waitlist Attention Control

NO INTERVENTION

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.

Interventions

Mindset Intervention 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).

Mindset Intervention

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Royal Marsden NHS Foundation Trust: collaborator

Study Sites (1)

The Royal Marsden

London, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lauren C Heathcote, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 22, 2024
• Study Start: November 29, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: De-identified IPD will be shared on an online, open science data repository platform from the time that the study has been published and will be available indefinitely.
• Access Criteria: De-identified IPD will be available open access.

Locations

GB (1)