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Multidisciplinary brain cancer rehabilitation, holistic assessment, and multimodal interventions to address survivorship needs: Brain Trial

Multidisciplinary brain cancer rehabilitation, holistic assessment, and multimodal interventions to address survivorship needs: Brain Trial Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000453785
Acronym
BRAIN TRIAL
Enrollment
30
Registered
2022-03-23
Start date
2022-04-04
Completion date
2022-10-03
Last updated
2022-03-28

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

Conditions

None listed

Brief summary

This study aims to prospectively assess the impact of multidisciplinary multimodal supportive care intervention on cancer selected outcomes in people diagnosed with high grade glioma (HGG) brain cancer and their family and/or caregiver. Who is it for? Adults (18+ years) diagnosed with high-grade (III-IV) gliomas, and if applicable their family and/or caregiver. Study details: 30 participants will be randomly allocated into one of two groups. One group (n=15) will receive standard care currently available at their clinical site (oral/written information and the contact details of the specialist nurse for additional support, if required). The other group (n=15) will undergo (needs-based) multimodal supportive care, which involves informational materials, holistic needs assessment, self-management care plan and a tailored exercise programme. It is anticipated the results of this study will improve health outcomes for cancer patients in Canberra by driving changes in local health procedures and policy to ensure better integrated multimodal supportive care based on routine, holistic needs assessments. This project may also have implications that inform care models both domestically and internationally.

Interventions

15 eligible participants (18+ years) and their family/caregiver will be randomly allocated to the needs-based multimodal supportive care intervention. There are four main components to the intervention arm and each participant will receive the following: (1) Informational Materials Participants will be provided with an evidence-based information booklet, designed specifically for this study. The booklet will take approximately 10 minutes to read through and will include: how to self-care, man

15 eligible participants (18+ years) and their family/caregiver will be randomly allocated to the needs-based multimodal supportive care intervention. There are four main components to the intervention arm and each participant will receive the following: (1) Informational Materials Participants will be provided with an evidence-based information booklet, designed specifically for this study. The booklet will take approximately 10 minutes to read through and will include: how to self-care, managing side-effects, nutrition and exercise, relationships and sexual well-being, healthy lifestyle approaches and community-based supports. Participants can review and refer back to the materials at their own discretion. (2) Holistic Needs Assessment Participants will have an individualised, face-to-face session at each out-patient clinical review appointment (total duration of 6 months). The anticipated duration of each session is 30 minutes in length. The Holistic Needs Assessment (HNA) questionnaire will be completed by patients and family/caregiver before the consultation. The information gathered from the HNA will then directly inform an individually tailored self-management care plan. Concerns and problems, as well as realistic goals/expectations will be discussed and any necessary referrals to other multidisciplinary team members will be provided. (3) Self-Management Care Plans Self-management care plans will be developed with the participants at the end of the discussion of the HNA and shared with GPs. The self-management care plans may include self-care advice for specific symptom management, along with any lifestyle recommendations that may benefit the individual participant. Each care plan will be reviewed and adjusted (where necessary) by a member of the research team, at the 2, 4 and 6 month follow-up appointments. (4) Physical Exercise Programme Exercises will be prescribed based on the needs of each participant, identified by the exercise physiologist and the individual during the initial data collection appointment. Exercises (cardiovascular and/or body weight/resistance) will be tailored to individual needs depending on individual abilities and any existing co-morbidities. The individual exercise programme may be completed at home or in a clinical rehabilitation gym with an exercise physiologist supervisor. Any restrictions and limits on the exercise programme will be based on the needs of each participant, identified by the exercise physiologist and the individual during the initial data collection appointment. Session attendance checklists will be implemented to assess and monitor adherence to the interventions.

Sponsors

University of Canberra
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

Patients (and family/caregiver) aged 18 years and over being treated for high-grade gliomas (III/IV), Karnofsky Performance Score (KPS) greater than 50, self-assessed written and verbal English proficiency, able to provide written informed consent.

Exclusion criteria

Estimated prognosis of fewer than 3 months, KPS <60 or those unable to follow verbal instructions.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026