CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Psychological and Behaviour Change SupportWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1654 Nutrition Wiki 1.00
drug1292 JNJ-66525433 Wiki 1.00
drug880 Exercise Wiki 0.71
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D014456 Ulcer NIH 0.41
D003092 Colitis NIH 0.41
D003093 Colitis, Ulcerative NIH 0.41

Correlated HPO Terms (2)

Name (Synonyms) Correlation
HP:0002583 Colitis HPO 0.41
HP:0100279 Ulcerative colitis HPO 0.41

There is one clinical trial.

Clinical Trials

1 SafeFit Trial: Virtual Clinics to Deliver Universal Interventions to Maintain and Improve Mental and Physical Health in People With Cancer Who Are Following Social Distancing Guidance: A COVID-19 Targeted Trial

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.

NCT04425616 Cancer COVID Other: Exercise Behavioral: Psychological and Behaviour Change Support Other: Nutrition

Primary Outcomes

Description: 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

Measure: Physical Function

Time: Baseline up to 1 year post enrolment

Secondary Outcomes

Description: 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

Measure: Emotional Function

Time: Baseline up to 1 year post enrolment

Description: 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

Measure: Health related quality of life

Time: Baseline up to 1 year post enrolment

Description: 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

Measure: Health economics analysis

Time: Baseline up to 1 year post enrolment

Description: 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 applicable

Measure: Patient activation

Time: Baseline up to 1 year post enrolment

Description: Measured using the Godin Leisure Time Exercise Questionnaire, a 7-day physical activity recall

Measure: Self-reported physical activity

Time: Baseline up to 1 year post enrolment

Description: 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

Measure: Nutrition assessment

Time: Baseline up to 1 year post enrolment

Description: 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.

Measure: Self-efficacy for self-management of chronic disease

Time: Baseline up to 1 year post enrolment

Description: Levels of distress as measured by the Emotions Thermometers. Participants will score on a scale where 0 = None and 10 = Extreme

Measure: Distress levels

Time: Baseline up to 1 year post enrolment

Description: The Dukes Activity Status Index is a 12 item self-report measure of functional capacity that can be used to estimate peak oxygen uptake

Measure: Functional capacity

Time: Baseline up to 1 year post enrolment

Description: 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.

Measure: The impact of COVID-19 pandemic on psychological functioning

Time: Baseline up to 1 year post enrolment

Description: Semi-structured interviews with participants and professionals to explore acceptability, usefulness and barriers to delivery/engagement

Measure: Process Evaluation

Time: Through study completion, an average of 12 months

Other Outcomes

Description: Overall survival at 1 year following date of enrolment

Measure: Exploratory: Overall survival

Time: 1 year post enrolment

Description: Adherence to intervention advice is defined as number of sessions the participants attends divided by the total number of sessions.

Measure: Exploratory: Adherence to the interventions/advice

Time: Baseline up to 1 year post enrolment

No related HPO nodes (Using clinical trials)