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

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,100

Participants

Timeline

Start Date

June 4, 2020

Primary Completion Date

October 13, 2023

Study Completion Date

March 31, 2024

Conditions
CancerCOVID
Interventions
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.

Trial Locations (1)

SO16 6YD

University Hospital Southampton NHS FT, Southampton

All Listed Sponsors
collaborator

Macmillan Cancer Support

OTHER

collaborator

CanRehab Trust

UNKNOWN

collaborator

Wessex Cancer Alliance

UNKNOWN

lead

University Hospital Southampton NHS Foundation Trust

OTHER

NCT04425616 - SafeFit Trial: Virtual Clinics to Deliver Universal Interventions in People With Cancer | Biotech Hunter | Biotech Hunter