SafeFit Trial: Virtual Clinics to Deliver Universal Interventions in People With Cancer

NCT ID: NCT04425616

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-04
• Study Completion Date: 2024-03-31

Brief 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.

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.

Conditions

Cancer; COVID

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Universal Interventions

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

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

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 Support

Intervention Type: BEHAVIORAL

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

Nutrition

Intervention Type: OTHER

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.

Interventions

Exercise

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

Intervention Type: OTHER

Psychological and Behaviour Change Support

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

Intervention Type: BEHAVIORAL

Nutrition

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Male or female participants, aged over 18 years old
• Suspicion or confirmed diagnosis of cancer (does not require histological confirmation)

Exclusion Criteria

• Participants unable to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Macmillan Cancer Support

OTHER

Sponsor Role: collaborator

CanRehab Trust

UNKNOWN

Sponsor Role: collaborator

Wessex Cancer Alliance

UNKNOWN

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Southampton NHS FT

Southampton, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34446487 (View on PubMed)

Other Identifiers

RHM CRI 0403

Identifier Type: -

Identifier Source: org_study_id