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
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.


Other: 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

Behavioral: 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

Other: 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.

Eligibility Criteria

Inclusion Criteria:

- Male or female participants, aged over 18 years old

- Suspicion or confirmed diagnosis of cancer (does not require histological

Exclusion Criteria:

- Participants unable to give informed consent

Eligibility Gender
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
United Kingdom

University Hospital Southampton NHS FT
Southampton, United Kingdom

Investigator: Sandy Jack, PhD
Contact: 02381205308


Sandy Jack, pHD

Samantha Leggett, BSc

University Hospital Southampton NHS Foundation Trust
NCT Number
Virtual clinics
Cancer diagnosis
Psychological support
Behaviour change