SafeFit Trial: Virtual Clinics to Deliver Universal Interventions in People With Cancer
- Conditions
- CancerCOVID
- Interventions
- Other: ExerciseBehavioral: Psychological and Behaviour Change SupportOther: Nutrition
- Registration Number
- NCT04425616
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1100
- Male or female participants, aged over 18 years old
- Suspicion or confirmed diagnosis of cancer (does not require histological confirmation)
- Participants unable to give informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Universal Interventions Nutrition 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 Universal Interventions Psychological and Behaviour Change Support 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 Universal Interventions Exercise 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
- Primary Outcome Measures
Name Time Method Physical Function Baseline up to 1 year post enrolment 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
- Secondary Outcome Measures
Name Time Method Emotional Function Baseline up to 1 year post enrolment 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
Health related quality of life Baseline up to 1 year post enrolment 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
Health economics analysis Baseline up to 1 year post enrolment 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
Patient activation Baseline up to 1 year post enrolment 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 applicableNutrition assessment Baseline up to 1 year post enrolment 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
Distress levels Baseline up to 1 year post enrolment Levels of distress as measured by the Emotions Thermometers. Participants will score on a scale where 0 = None and 10 = Extreme
Functional capacity Baseline up to 1 year post enrolment The Dukes Activity Status Index is a 12 item self-report measure of functional capacity that can be used to estimate peak oxygen uptake
The impact of COVID-19 pandemic on psychological functioning Baseline up to 1 year post enrolment 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.
Self-efficacy for self-management of chronic disease Baseline up to 1 year post enrolment 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.Process Evaluation Through study completion, an average of 12 months Semi-structured interviews with participants and professionals to explore acceptability, usefulness and barriers to delivery/engagement
Self-reported physical activity Baseline up to 1 year post enrolment Measured using the Godin Leisure Time Exercise Questionnaire, a 7-day physical activity recall
Trial Locations
- Locations (1)
University Hospital Southampton NHS FT
🇬🇧Southampton, United Kingdom