Trial Phase: Phase III: Interventional Trial: Virtual clinics to deliver universalinterventions to maintain and improve physical health, nutritional state andpsychological wellbeing in people with cancer who are following social distancingguidance: A COVID-19 targeted trial.Indication: Male or female participants, aged over 18 years old with suspicion orconfirmed diagnosis of cancer (does not require histological confirmation)Objective: To investigate the efficacy of remote multimodal universal interventionsdelivered via virtual clinics to improve physical function as measured by theEORTC-QLQ-C30.Secondary Objective:To investigate the efficacy of remote multimodal universal interventions delivered viavirtual 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 ordevelopment of a web-based toolkit.
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.
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
University Hospital Southampton NHS FT
Southampton, United Kingdom