CancerNCT04425616
SafeFit Trial: Virtual Clinics to Deliver Universal Interventions in People With Cancer
A study testing Exercise, Psychological and Behaviour Change Support and Nutrition in people with Cancer and COVID, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universal interventions to maintain and improve physical health, nutritional state and psychological wellbeing in people with cancer who are following social distancing guidance: A COVID-19 targeted trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Exercise, Psychological and Behaviour Change Support and Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jun 2020to 31 Mar 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants, aged over 18 years old
- Suspicion or confirmed diagnosis of cancer (does not require histological confirmation)
Who cannot join
- Participants unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton NHS FT
Southampton, SO16 6YD
About this study
Official title: SafeFit Trial: Virtual Clinics to Deliver Universal Interventions to Maintain and Improve Mental and Physical Health in People With Cancer Who Are Following Social Distancing Guidance: A COVID-19 Targeted Trial
Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universal interventions to maintain and improve physical health, nutritional state and psychological wellbeing in people with cancer who are following social distancing guidance: A COVID-19 targeted trial.
Indication: Male or female participants, aged over 18 years old with suspicion or confirmed diagnosis of cancer (does not require histological confirmation)
Read more
Objective: To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve physical function as measured by the EORTC-QLQ-C30.
Secondary Objective:
To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve emotional function, quality of life, participant activation (PAM), behaviour change and the effect it has on health economics (EQ-5D-5L).
Exploratory Objective:
Overall Survival and adherence to the intervention/advice using validated tools or development of a web-based toolkit.
Read the detailed description
Rationale: A recent statement by Professor Chris Whitty, Chief Medical Officer, NHS England, emphasised the significant benefits of exercise for all people. He said, "this may be challenging for people self-isolating and even more so for those highly vulnerable people that are having to shield against the virus in their own homes" The coronavirus (COVID-19) pandemic has led to many changes to everyday life including the introduction of social distancing as well as restriction of travel. Treatment plans for patients with cancer are being revised or modified due to risks and benefits of certain treatments in light of the COVID-19 risk. The number of deaths due to the disruption in cancer services is likely to outweigh the number of deaths from coronavirus itself over the next five years.
The effects of this pandemic has reportedly led to increased anxiety and distress and risks deconditioning due to reduced physical activity. The interventions we are proposing aim to enable people with cancer to optimise their physical health, nutritional state and psychological wellbeing and prepare for their treatment pathway (current or modified) and recovery during this uncertain time through exercise, nutrition and psychological support.
The aim is to investigate whether the promotion of these interventions delivered via virtual clinics, in socially distanced people with cancer, can improve physical and psychological function and self-efficacy to self-manage. We are also aiming to evaluate health economics whilst following the COVID-19 government guidelines.
Trial Design: Phase III: Non randomised Interventional Trial
Sample Size: 1100
Intervention: Provision of dietary, exercise and psychological advice as well as behaviour change support (universal interventions) as aligned to the universal interventions (with the caveats of COVID-19) in the Macmillan 'Principles and guidance for prehabilitation within the management and support of people with cancer' guideline. This complex intervention will be prescribed and delivered through virtual clinics where CanRehab professionals will support the individual. Level 3 Personal Trainers may also deliver the interventions in some cases with a GP referral qualification and who are competent in delivering the interventions to participants with cancer post-treatment.
- Being tested
- Exercise, Psychological and Behaviour Change Support, Nutrition
- Keywords
- COVID-19, Virtual clinics, Exercise, Cancer diagnosis, Nutrition, Psychological support, Behaviour change
- Medical subject headings
- Neoplasms, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
At least one and up to three supervised sessions per week including:
- aerobic exercise at a rating of perceived exertion of 11-14 (6-20 scale) accumulating 20 minutes per session
- resistance exercise of 8-10 exercises for 2x 8-15 repetitions performed in a controlled manner and covering the whole body
- Range of motion exercise performed through pain free range of motion covering the whole body to be maintained in good alignment for 10-30 seconds, with some movements held for a second set of 10-30 seconds if stiff
Psychological and Behaviour Change SupportBehavioural
Instructors will be trained in Healthy Conversation Skills (HCS), Making Every Contact Count (MECC) or equivalent. This will enable them to deliver brief participant centred empowering interventions informed by social cognitive theory. This skill set will be used to support participants in adopting and maintaining the prescribed exercise and diet programme as well as adopting and practicing strategies to self-manage psychological well-being. Participants will be given the option to be provided with a SMARTER goal setting sheet to assist with goal planning. Applicable standardised psychological support resources will be made available to the participants though the Macmillan resource repository that they can access online or in alternative format as necessary, for example relaxation and mindfulness exercises
NutritionOther
Instructors will receive training in generic nutritional principles in line with recommendations from World Cancer Research Fund (WCRF) and British Dietetic Association, and will work with participant to review own diet and eating habits against WCRF recommendations to enable goal setting and identify links to existing resources reputable websites, outputs and on-line forums. These would include: principles of healthy eating ('eat well' advice), weight management, symptom management, prehab advice before treatment starts, rehab advice during and after treatment. The participant will be asked if they are eating and drinking well or have any concerns at the beginning of each exercise session. Further support will be provided to instructors to address participant concerns or requests for additional information.
| Study group | Role | What they receive |
|---|---|---|
| Universal Interventions | Experimental | The delivery of nutrition, exercise and psychological interventions delivered in the following structure:
* Month 1: Up to three times per week
* Months 2-3: Once per week
* Months 4 - 6: One session per month for the last 3 months Receives: Other: Exercise; Behavioral: Psychological and Behaviour Change Support; Other: Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function
Physical function will be measured using the EORTC-QLQ-C30. Participants will choose from the choices 1 = Not at all; 2 = A little, 3 = Quite a bit, 4 = Very much
Measured: Baseline up to 1 year post enrolment
Secondary outcomes (11)
Emotional Function
Emotional function will be measured using the EORTC-QLQ-C30. Participants will choose from the choices 1 = Not at all; 2 = A little, 3 = Quite a bit, 4 = Very much
Measured: Baseline up to 1 year post enrolment
Health related quality of life
EQ-5D-5L is a standardised measure of health status developed by the EuroQol Group. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical evaluation of health care
Measured: Baseline up to 1 year post enrolment
Health economics analysis
EQ-5D-5L is a standardised measure of health status developed by the EuroQol Group. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the economic evaluation of health care
Measured: Baseline up to 1 year post enrolment
Patient activation
Patients knowledge skills and confidence to manage their own health and care will be measured using the Patient Activation Measure (PAM)
Agreement or disagreement with statements. Choice between disagree strongly, disagree, agree, agree strongly and not applicable
Measured: Baseline up to 1 year post enrolment
Self-reported physical activity
Measured using the Godin Leisure Time Exercise Questionnaire, a 7-day physical activity recall
Measured: Baseline up to 1 year post enrolment
Nutrition assessment
In the oncology population where malnutrition prevalence is high, the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF) is a descriptive screening tool that can provide further information to assist triaging and capture acute change in nutritional state
Measured: Baseline up to 1 year post enrolment
Self-efficacy for self-management of chronic disease
Self-efficacy (confidence) to self-manage chronic disease (SEMCD), measured using the Lorig SEMCD scale
A confidence scale that represents the patients confidence that a regular task can be achieved. 1 = Not confident at all and 10= totally confident.
Measured: Baseline up to 1 year post enrolment
Distress levels
Levels of distress as measured by the Emotions Thermometers. Participants will score on a scale where 0 = None and 10 = Extreme
Measured: Baseline up to 1 year post enrolment
Functional capacity
The Dukes Activity Status Index is a 12 item self-report measure of functional capacity that can be used to estimate peak oxygen uptake
Measured: Baseline up to 1 year post enrolment
The impact of COVID-19 pandemic on psychological functioning
As measured by the Impact of Event Scale - a 22-item self-report measure of the imapact of a specific traumatic event against the DSM criteria for Post Traumatic Stress Disorder. 0 = Not at all and 4 = Extremely.
Measured: Baseline up to 1 year post enrolment
Process Evaluation
Semi-structured interviews with participants and professionals to explore acceptability, usefulness and barriers to delivery/engagement
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start4 Jun 2020
- Primary completion13 Oct 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomised phase III interventional trial
- Masking
- None (open label)
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Macmillan Cancer Support, CanRehab Trust, Wessex Cancer Alliance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425616
- Sponsor's protocol ID
- RHM CRI 0403
- Status last verified
- Nov 2023
- First submitted
- 3 Jun 2020
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grimmett C, Bates A, West M, Leggett S, Varkonyi-Sepp J, Campbell A, Davis J, Wootton S, Shaw C, Barlow R, Ashcroft J, Scott A, Moyes H, Hawkins L, Levett DZH, Williams F, Grocott MPW, Jack S. SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial. BMJ Open. 2021 Aug 26;11(8):e048175. doi: 10.1136/bmjopen-2020-048175.
PubMed 34446487
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SafeFit Trial: Virtual Clinics to Deliver Universal Interventions to Maintain and Improve Mental and Physical Health in People With Cancer Who Are Following Social Distancing Guidance: A COVID-19 Targeted Trial
- ClinicalTrials.gov ID
- NCT04425616
- Acronym / sponsor ID
- RHM CRI 0403
- Keywords
- COVID-19, Virtual clinics, Exercise, Cancer diagnosis, Nutrition, Psychological support, Behaviour change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Macmillan Cancer Support, CanRehab Trust, Wessex Cancer Alliance
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 11 Jun 2020 (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.
Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universal interventions to maintain and improve physical health, nutritional state and psychological wellbeing in people with cancer who are following social distancing guidance: A COVID-19 targeted trial.
Indication: Male or female participants, aged over 18 years old with suspicion or confirmed diagnosis of cancer (does not require histological confirmation)
Objective: To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve physical function as measured by the EORTC-QLQ-C30.
Secondary Objective:
To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve emotional function, quality of life, participant activation (PAM), behaviour change and the effect it has on health economics (EQ-5D-5L).
Exploratory Objective:
Overall Survival and adherence to the intervention/advice using validated tools or development of a web-based toolkit.
Detailed description
Rationale: A recent statement by Professor Chris Whitty, Chief Medical Officer, NHS England, emphasised the significant benefits of exercise for all people. He said, "this may be challenging for people self-isolating and even more so for those highly vulnerable people that are having to shield against the virus in their own homes" The coronavirus (COVID-19) pandemic has led to many changes to everyday life including the introduction of social distancing as well as restriction of travel. Treatment plans for patients with cancer are being revised or modified due to risks and benefits of certain treatments in light of the COVID-19 risk. The number of deaths due to the disruption in cancer services is likely to outweigh the number of deaths from coronavirus itself over the next five years.
The effects of this pandemic has reportedly led to increased anxiety and distress and risks deconditioning due to reduced physical activity. The interventions we are proposing aim to enable people with cancer to optimise their physical health, nutritional state and psychological wellbeing and prepare for their treatment pathway (current or modified) and recovery during this uncertain time through exercise, nutrition and psychological support.
The aim is to investigate whether the promotion of these interventions delivered via virtual clinics, in socially distanced people with cancer, can improve physical and psychological function and self-efficacy to self-manage. We are also aiming to evaluate health economics whilst following the COVID-19 government guidelines.
Trial Design: Phase III: Non randomised Interventional Trial
Sample Size: 1100
Intervention: Provision of dietary, exercise and psychological advice as well as behaviour change support (universal interventions) as aligned to the universal interventions (with the caveats of COVID-19) in the Macmillan 'Principles and guidance for prehabilitation within the management and support of people with cancer' guideline. This complex intervention will be prescribed and delivered through virtual clinics where CanRehab professionals will support the individual. Level 3 Personal Trainers may also deliver the interventions in some cases with a GP referral qualification and who are competent in delivering the interventions to participants with cancer post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomised phase III interventional trial
| Arm | Type | Receives |
|---|---|---|
| Universal Interventions | Experimental | Other: Exercise, Behavioral: Psychological and Behaviour Change Support, Other: NutritionThe delivery of nutrition, exercise and psychological interventions delivered in the following structure: * Month 1: Up to three times per week * Months 2-3: Once per week * Months 4 - 6: One session per month for the last 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female participants, aged over 18 years old
- Suspicion or confirmed diagnosis of cancer (does not require histological confirmation)
Key exclusion criteria (1 listed)
- Participants unable to give informed consent
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 |
|---|---|---|
| ExerciseAt least one and up to three supervised sessions per week including: * aerobic exercise at a rating of perceived exertion of 11-14 (6-20 scale) accumulating 20 minutes per session * resistance exercise of 8-10 exercises for 2x 8-15 repetitions performed in a controlled manner and covering the whole body * Range of motion exercise performed through pain free range of motion covering the whole body to be maintained in good alignment for 10-30 seconds, with some movements held for a second set of 10-30 seconds if stiff | Other | Universal Interventions |
| Psychological and Behaviour Change SupportInstructors will be trained in Healthy Conversation Skills (HCS), Making Every Contact Count (MECC) or equivalent. This will enable them to deliver brief participant centred empowering interventions informed by social cognitive theory. This skill set will be used to support participants in adopting and maintaining the prescribed exercise and diet programme as well as adopting and practicing strategies to self-manage psychological well-being. Participants will be given the option to be provided with a SMARTER goal setting sheet to assist with goal planning. Applicable standardised psychological support resources will be made available to the participants though the Macmillan resource repository that they can access online or in alternative format as necessary, for example relaxation and mindfulness exercises | Behavioural | Universal Interventions |
| NutritionInstructors will receive training in generic nutritional principles in line with recommendations from World Cancer Research Fund (WCRF) and British Dietetic Association, and will work with participant to review own diet and eating habits against WCRF recommendations to enable goal setting and identify links to existing resources reputable websites, outputs and on-line forums. These would include: principles of healthy eating ('eat well' advice), weight management, symptom management, prehab advice before treatment starts, rehab advice during and after treatment. The participant will be asked if they are eating and drinking well or have any concerns at the beginning of each exercise session. Further support will be provided to instructors to address participant concerns or requests for additional information. | Other | Universal Interventions |
Primary outcome
Physical Function
Time frame: Baseline up to 1 year post enrolment
Physical function will be measured using the EORTC-QLQ-C30. Participants will choose from the choices 1 = Not at all; 2 = A little, 3 = Quite a bit, 4 = Very much
11 secondary outcomes
Emotional Function
Time frame: Baseline up to 1 year post enrolment
Health related quality of life
Time frame: Baseline up to 1 year post enrolment
Health economics analysis
Time frame: Baseline up to 1 year post enrolment
Patient activation
Time frame: Baseline up to 1 year post enrolment
Self-reported physical activity
Time frame: Baseline up to 1 year post enrolment
Nutrition assessment
Time frame: Baseline up to 1 year post enrolment
Self-efficacy for self-management of chronic disease
Time frame: Baseline up to 1 year post enrolment
Distress levels
Time frame: Baseline up to 1 year post enrolment
Functional capacity
Time frame: Baseline up to 1 year post enrolment
The impact of COVID-19 pandemic on psychological functioning
Time frame: Baseline up to 1 year post enrolment
Process Evaluation
Time frame: Through study completion, an average of 12 months
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 2 Dec 2025.
- Derived from this study: PubMed 34446487Grimmett C, Bates A, West M, Leggett S, Varkonyi-Sepp J, Campbell A, Davis J, Wootton S, Shaw C, Barlow R, Ashcroft J, Scott A, Moyes H, Hawkins L, Levett DZH, Williams F, Grocott MPW, Jack S. SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial. BMJ Open. 2021 Aug 26;11(8):e048175. doi: 10.1136/bmjopen-2020-048175.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Psychological and Behaviour Change Support and Nutrition in people with Cancer and COVID, run by University Hospital Southampton NHS Foundation Trust 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 2 inclusion and 1 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 2 Dec 2025. 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?
Physical Function (time frame: Baseline up to 1 year post enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04425616, which also lists 1 linked publication.
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 2 Dec 2025.