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

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)

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.

Study Overview

• Status: Completed
• Conditions: Cancer; COVID
• Intervention / Treatment: Other: Exercise; Behavioral: Psychological and Behaviour Change Support; Other: Nutrition

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 Type: Interventional
• Enrollment (Actual): 1100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Southampton, United Kingdom, SO16 6YD
    • University Hospital Southampton NHS FT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline up to 1 year post enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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.	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	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	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.	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	Through study completion, an average of 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory: Overall survival	Overall survival at 1 year following date of enrolment	1 year post enrolment
Exploratory: Adherence to the interventions/advice	Adherence to intervention advice is defined as number of sessions the participants attends divided by the total number of sessions.	Baseline up to 1 year post enrolment

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: Macmillan Cancer Support; CanRehab Trust; Wessex Cancer Alliance

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Actual): October 13, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Estimated): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; COVID-19; Nutrition; Psychological support; Behaviour change; Cancer diagnosis; Virtual clinics
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Behavior; COVID-19; Neoplasms; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Population Characteristics; Health Status; Demography; Exercise; Nutritional Status
• Other Study ID Numbers: RHM CRI 0403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No