CancerEMBodyNCT06702371
Digital Body Mindset Intervention for Young Cancer Survivors
A study testing Mindset Intervention in people with Cancer, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Cancer
- What is being tested?
- Mindset Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Nov 2024to 6 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: EMBody ('Exploring Mindsets About the Body'): Harnessing Adaptive Body Mindsets to Improve Outcomes in Childhood & AYA Cancer Survivors
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Mindset Intervention
- Keywords
- Childhood Cancer, Survivors of Childhood Cancer, Mindsets, Mindset Intervention, Adolescent and Young Adult (AYA), Wise Intervention, Body Mindsets
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindset InterventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Pain
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.
Measured: 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
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).
Measured: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)
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.
Measured: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Post-Traumatic Growth Inventory (PTGI)
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).
Measured: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Bodily Threat Monitoring Scale (BTMS)
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.
Measured: 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
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.
Measured: 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 in young adults
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.
Measured: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Global Impression of Change
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.
Measured: Week 6 (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start29 Nov 2024
- Primary completion1 Jan 2026
- Study completion6 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Lauren C Heathcote, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702371
- Sponsor's protocol ID
- 324319
- Other IDs
- MRF-015-0001-RG-HEAT-C0955
- Acronym
- EMBody
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared with other researchers to comply with open science practices.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMBody ('Exploring Mindsets About the Body'): Harnessing Adaptive Body Mindsets to Improve Outcomes in Childhood & AYA Cancer Survivors
- ClinicalTrials.gov ID
- NCT06702371
- Acronym / sponsor ID
- EMBody / 324319
- Conditions
- Cancer
- Keywords
- Childhood Cancer, Survivors of Childhood Cancer, Mindsets, Mindset Intervention, Adolescent and Young Adult (AYA), Wise Intervention, Body Mindsets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 6 Sep 2026 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mindset Intervention | Experimental | Behavioral: Mindset InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindset InterventionThe 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). | Behavioural | Mindset Intervention |
Primary outcome
Health-Related Quality of Life
Time frame: 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.
11 secondary outcomes
Body Mindsets
Time frame: 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
Time frame: 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
Time frame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Pain
Time frame: 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
Time frame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Fear of Cancer Recurrence Inventory Short Form (FCRI-SF)
Time frame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Post-Traumatic Growth Inventory (PTGI)
Time frame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Bodily Threat Monitoring Scale (BTMS)
Time frame: 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
Time frame: 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 in young adults
Time frame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up
Global Impression of Change
Time frame: Week 6 (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared with other researchers to comply with open science practices.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren C Heathcote, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindset Intervention in people with Cancer, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (time frame: Assessed at all timepoints through study completion (2, 4, 6, 10, 18 weeks post-randomisation) and at the additional 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.