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

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

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.

Sponsors & Collaborators

• Macmillan Cancer Support

  collaborator OTHER

• CanRehab Trust

  collaborator UNKNOWN

• Wessex Cancer Alliance

  collaborator UNKNOWN

• University Hospital Southampton NHS Foundation Trust

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-04

Primary Completion

2023-10-13

Completion

2024-03-31

Countries

• United Kingdom

Study Locations