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Trial registered on ANZCTR


Registration number
ACTRN12624000038594
Ethics application status
Approved
Date submitted
23/10/2023
Date registered
17/01/2024
Date last updated
17/01/2024
Date data sharing statement initially provided
17/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrative Supportive Care Trial to Enhance physical Activity in Malignant pleural effusion (The Australasian Malignant PLeural Effusion (AMPLE)-5 Trial)
Scientific title
Integrative Supportive Care Trial to Enhance physical Activity in Malignant pleural effusion
Secondary ID [1] 310519 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
ISC-TEAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant pleural effusion 331324 0
Condition category
Condition code
Cancer 328081 328081 0 0
Lung - Mesothelioma
Cancer 328082 328082 0 0
Other cancer types
Respiratory 329154 329154 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Integrated Supportive Care Program
Participants will attend integrated supportive care program at week 1, week 4, and week 8. Multidisciplinary treatment of individualised care plans will be delivered by accredited dieticians, exercise physiologists/physiotherapists, and clinical psychologist/specially trained nurse.
Prior to each appointment participants will complete a needs assessment screening to assess psychological distress, physical activity participation and nutritional status. Prior to each appointment the mulitdisciplinary team will discuss a plan. At each appointment participants will receive individual consultations with the each of the multidisciplinary team (e.g., nurse, dietitian, exercise physiologist/physiotherapist). Visits will be completed by tele-health (either by video-conference software, audio/teleconsult) or in-person appointment if required. Visits with each specialist will be up-to 20 minutes (up to 60 minutes total for the participants).
(1) Dietetics: Nutrition counselling involves the provision of personalized recommendations for increasing energy and protein intake using normal food, and oral nutrition supplements (i.e., ‘high energy, high protein’ drinks) when required.
2) Psychology. Psychological counselling will include review of distress and psychological needs and implementing a plan to specifically identify and refer to appropriate support services for psychosocial care. At subsequent counselling sessions this plan will be re-evaluating and adjusted the plan as appropriate. This will be delivered by a nurse with specialist experience in malignant pleural effusion.
3) Physical Activity. Exercise counselling involves the provision of personalized recommendations for increasing physical activity participation (or maintaining participation as appropriate), and reducing sedentary time, and breaking up sedentary time. will include education, identification of appropriate programs and resources (e.g., Cancer Council WA Life Now program, or neighbourhood walking trails), behavioural support (e.g., goal setting, planning, identification of barriers and facilitators for physical activity), and tools for managing symptoms during physical activity, and suggestions for reducing sedentary time. Participants will be provided with the ‘Cancer Council WA Exercise for People Living with Cancer, A guide for people with cancer, their families and friends’.
Adherence will be monitored by session attendance checklist.
Intervention code [1] 326911 0
Rehabilitation
Intervention code [2] 326913 0
Behaviour
Comparator / control treatment
Standard care, as per attending physician, with referral to supportive services if indicated.

Control group
Active

Outcomes
Primary outcome [1] 335947 0
Physical activity level will be assessed as steps per day, measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [1] 335947 0
This will be a 7-day assessment of at baseline (enrolment) and a 7-day assessment of physical activity Post-intervention (week 13)
Secondary outcome [1] 426241 0
Quality of life. The EuroQoL­5 Dimensions­5 Levels will be used to assess quality of life.
Timepoint [1] 426241 0
baseline, post-intervention (week 13)
Secondary outcome [2] 427875 0
Malnutrition risk, will be assessed using the Patient-Generated Subjective Global Assessment Short-Form
Timepoint [2] 427875 0
baseline, post-intervention (week 13)
Secondary outcome [3] 427876 0
Psychopathology. Clinical symptoms of depression and generalized anxiety will be measured using the Patient Health Questionnaire-4 as a composite measure.
Timepoint [3] 427876 0
baseline, post-intervention (week 13)
Secondary outcome [4] 427877 0
Symptom profile. The Edmonton Symptom Assessment Scale (ESAS) will be used to assess symptom burden of participants.
Timepoint [4] 427877 0
baseline, post-intervention (week 13)
Secondary outcome [5] 427878 0
Duration and patterns rest time will be assessed measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [5] 427878 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days.
Secondary outcome [6] 427879 0
Program barriers, facilitators, acceptability and value of the integrative supportive care program will be assessed via Likert scales and through open-ended questions that have been specifically designed for this study.
Timepoint [6] 427879 0
post-intervention (week 13)
Secondary outcome [7] 427880 0
Compliance. Attendance at telehealth sessions (number completed/3, including the reason for any missed sessions). These will be collected by study-specific attendance logs.
Timepoint [7] 427880 0
post-intervention (week 13)
Secondary outcome [8] 427881 0
Adverse events. The incidence and severity of any adverse events (e.g. fall, muscle strain) as categorised by ICH-GCP guidelines will be monitored and documented during telehealth sessions, or telephone follow-up.
Timepoint [8] 427881 0
Week 4, post intervention commencement, week 8 post intervention commencement, and Week 12 post intervention commencement
Secondary outcome [9] 427886 0
Appetite. The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Appetite/Cachexia Scale will be used to assess appetite.
Timepoint [9] 427886 0
baseline and post-intervention (13-weeks)
Secondary outcome [10] 427887 0
Breathlessness. A 100mm visual analogue scale (VAS) anchored with “no breathlessness” at 0mm and “worst breathlessness imaginable” at 100mm will assess breathlessness
Timepoint [10] 427887 0
baseline and post-intervention (week 13)
Secondary outcome [11] 427888 0
Fatigue. The Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) subscale will be used to assess severity of fatigue.
Timepoint [11] 427888 0
baseline and post-intervention (week 13)
Secondary outcome [12] 430303 0
Standing time will be assessed measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [12] 430303 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days.
Secondary outcome [13] 430304 0
Walking time will be assessed measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [13] 430304 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days.
Secondary outcome [14] 430305 0
High intensity movement time will be assessed measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [14] 430305 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days
Secondary outcome [15] 430306 0
sleep time and quality measured by (Sens Motion Activity Sensors) on their upper
Timepoint [15] 430306 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days.
Secondary outcome [16] 430307 0
Sedentary time will be assessed measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [16] 430307 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days.
Secondary outcome [17] 430308 0
Low intensity physical activity time will be assessed measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [17] 430308 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days.
Secondary outcome [18] 430310 0
Sporadic walking time will be assessed measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [18] 430310 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days.
Secondary outcome [19] 430311 0
Moderate intensity physical activity time will be assessed measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [19] 430311 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days.
Secondary outcome [20] 430312 0
Lying/sitting movement will be assessed measured by accelerometer (Sens Motion Activity Sensors) on their upper thigh.
Timepoint [20] 430312 0
baseline (enrolment) for 7-days, post-intervention (week 13) for 7-days.

Eligibility
Key inclusion criteria
1. Patients with previously confirmed MPE (histo-/cyto-logically confirmed OR recurrent large exudative pleural effusion with histo-cytologically proven cancer outside the thorax and no alternative cause)
2. Estimated survival of 3 months (the length of the supportive care intervention)
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age <18 years
2. Inability to consent
3. Inability to comply with protocol
4. Pregnancy/lactation
5. ECOG >3

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who was at central administration site. The allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Automatic randomization following the entry of baseline minimisation data will be confirmed by emails sent to the enrolling and the lead sites.
Randomisation is stratified for i) cancer type (mesothelioma vs non-mesothelioma); ii) ECOG performance status (0/1 vs greater than or equal to 2) and iii) current cancer treatment (chemotherapy/immunotherapy/radiation therapy) vs not.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/01/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25736 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 41560 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 314722 0
Charities/Societies/Foundations
Name [1] 314722 0
ICare. Insurance and Care NSW (ABN 16 759 382 489)
Country [1] 314722 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Institute of Respiratory Health
Address
Level 2/6 Verdun St, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 316692 0
None
Name [1] 316692 0
Address [1] 316692 0
Country [1] 316692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313731 0
Sir Charles Gairdner Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 313731 0
Human Research Ethics Office Sir Charles Gairdner Hospital A Block Hospital Avenue Nedlands WA 6009
Ethics committee country [1] 313731 0
Australia
Date submitted for ethics approval [1] 313731 0
28/02/2023
Approval date [1] 313731 0
02/05/2023
Ethics approval number [1] 313731 0
RGS0000005974

Summary
Brief summary
Patients with malignant pleural effusion (MPE) and their carers report high rates of unmet supportive care needs. Multi-disciplinary interventions, specifically addressing nutrition, targeted physical activity counselling, and psychological support are recommended by international guidelines for advanced cancer.

This study aims to find out if integrated supportive care involving nutritional, physical activity, and psychological well-being care plans can improve participation in daily physical activity in people with MPE. The study also aims to find out if this multidisciplinary counselling can improve quality of life, malnutrition risk, psychological well-being, and symptoms.

Who is it for?
You may be eligible for this study if you are aged 19 years or older, and have been diagnosed with a malignant pleural effusion and you are willing to comply with the research procedures.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. The first group will take part in the integrated supportive care program. This program lasts for 12-weeks and includes counselling sessions in week 1, week 4, and week 8. Each counselling session will take about one hour to complete. This includes about 20 minutes each for dietetics, physical activity, and psychological well-being. The second group will will receive standard medical care as per attending physician, with referral to supportive services if indicated. This group will be called by a member of the research team at week 4 and week 8 to discuss any adverse events that have happened to you.
Both groups will receive standard medical care from their treating physician throughout the study, including access to support services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129174 0
Dr Carolyn McIntyre
Address 129174 0
Pleural Medicine Unit B-Block Sir Charles Gairdner Hospital Hospital Avenue Nedlands WA 6009
Country 129174 0
Australia
Phone 129174 0
+61 421253918
Fax 129174 0
Email 129174 0
c.mcintyre@ecu.edu.au
Contact person for public queries
Name 129175 0
Dr Carolyn McIntyre
Address 129175 0
Pleural Medicine Unit B-Block Sir Charles Gairdner Hospital Hospital Avenue Nedlands WA 6009
Country 129175 0
Australia
Phone 129175 0
+61 421253918
Fax 129175 0
Email 129175 0
c.mcintyre@ecu.edu.au
Contact person for scientific queries
Name 129176 0
Dr Carolyn McIntyre
Address 129176 0
Pleural Medicine Unit B-Block Sir Charles Gairdner Hospital Hospital Avenue Nedlands WA 6009
Country 129176 0
Australia
Phone 129176 0
+61 421253918
Fax 129176 0
Email 129176 0
c.mcintyre@ecu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20656Study protocol  c.mcintyre@ecu.edu.au
20657Informed consent form  c.mcintyre@ecu.edu.au
20658Ethical approval  c.mcintyre@ecu.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.