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Integrative Supportive Care Trial to Enhance physical Activity in Malignant pleural effusion (The Australasian Malignant PLeural Effusion (AMPLE)-5 Trial)

Integrative Supportive Care Trial to Enhance physical Activity in Malignant pleural effusion

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000038594
Acronym
ISC-TEAM
Enrollment
34
Registered
2024-01-17
Start date
2024-05-02
Completion date
2025-09-01
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Institute of Respiratory Health
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No

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)

Exclusion criteria

1. Age <18 years 2. Inability to consent 3. Inability to comply with protocol 4. Pregnancy/lactation 5. ECOG >3

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026