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

NCT04425616 | Completed

• 1 other identifier: RHM CRI 0403
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; COVID

Keywords

COVID-19; Virtual clinics; Exercise; Cancer diagnosis; Nutrition; Psychological support; Behaviour change

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Emotional Function

  Baseline up to 1 year post enrolment

• Health related quality of life

  Baseline up to 1 year post enrolment

• Health economics analysis

  Baseline up to 1 year post enrolment

• Patient activation

  Baseline up to 1 year post enrolment

• Self-reported physical activity

  Baseline up to 1 year post enrolment

Other Outcomes (2)

• Exploratory: Overall survival

  1 year post enrolment

• Exploratory: Adherence to the interventions/advice

  Baseline up to 1 year post enrolment

Study Arms (1)

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

Other: Exercise; Behavioral: Psychological and Behaviour Change Support; Other: Nutrition

Interventions

Exercise 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

Universal Interventions

Psychological and Behaviour Change Support 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

Universal Interventions

Nutrition 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.

Universal Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Participants unable to give informed consent

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Macmillan Cancer Support: collaborator
• CanRehab Trust: collaborator
• Wessex Cancer Alliance: collaborator

Study Sites (1)

University Hospital Southampton NHS FT

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34446487 DERIVED

MeSH Terms

Conditions

Neoplasms; COVID-19; Motor Activity

Interventions

Exercise; Nutritional Status

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomised phase III interventional trial

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: June 4, 2020
• Primary Completion: October 13, 2023
• Study Completion: March 31, 2024
• Last Updated: December 2, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)