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Trial registered on ANZCTR

Registration number

ACTRN12612001148864

Ethics application status

Approved

Date submitted

28/10/2012

Date registered

30/10/2012

Date last updated

20/12/2018

Date data sharing statement initially provided

20/12/2018

Date results provided

20/12/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

A pilot study of caregiver intervention and support for carers of people with brain tumours

Scientific title

A pilot study of a supportive educational intervention for caregivers of patients with high grade glioma

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1136-3146

Trial acronym

Care-IS Pilot

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Efficacy of Intervention for brain tumour caregivers

Preparedness to care

Caregiver Competence

Caregiver Strain

Condition category

Condition code

Other

Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In this pilot study, the intervention will be carried out for 6 months but the main assessments will only occur at baseline, 6 weeks and 3 months.
The Intervention is a supportive educational intervention for caregivers. It will be in four parts and delivered in a sequential manner:
1. An initial telephone assessment of current unmet needs of the caregiver by research nurse. In the pilot study this will occur after registration and in the intervention study after randomisation to the intervention group. This should take 20 minutes.
2. 7-14 days later, a single home visit where the research nurse will provide support and education around the issues that have arisen in the telephone assessment and baseline survey of unmet need. The research nurse will also deliver the information folder specified below. It is expected that these home visits may take 60-90 minutes.
3. Caregviers will be given a tabbed supportive and educational information resource file which is specifically tailored for the caregiver as appropriate for their identified unmet needs. As new needs are identified, further information sheets will be supplied to the caregiver to insert into their resource folder.
4. Ongoing monthly telephone support and assessment of new needs as they arise. These will commence a month after the delivery of the intervention. These telephone assesments should take about 10 minutes unless prolonged by the participants.

Intervention code [1]

Treatment: Other

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility of the intervention and assessments as assessed in a feasibility questionnaire, rates of compliance and exclusion of surveys with floor or ceiling effects

Timepoint [1]

Baseline, 6 weeks and 3 months post intervention.

Secondary outcome [1]

Preparedness for Caregiving Scale (PCS)

Timepoint [1]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [2]

Distress Thermometer

Timepoint [2]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [3]

Hospital Anxiety and Depression Scale (HADS)

Timepoint [3]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [4]

Caregiver Quality of Life Index—Cancer (CQOLC)

Timepoint [4]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [5]

Carer Competence Scale

Timepoint [5]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [6]

Caregiver Strain Index

Timepoint [6]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [7]

Modified Caregiver Strain Index

Timepoint [7]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [8]

Partner and Caregiver Supportive Care Needs Scale

Timepoint [8]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [9]

Brain Tumour Specific Supportive Care needs for Carers
survey

Timepoint [9]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [10]

European Cooperative Oncology Group (ECOG) Performance Status (patient’s level of functioning)

Timepoint [10]

Baseline and monthly (total of 6 months)

Secondary outcome [11]

Karnofsky performance scale (patient's functional impairment)

Timepoint [11]

Baseline and monthly (total of six months)

Secondary outcome [12]

EuroQoL (EQ-5D)

Timepoint [12]

Baseline, 6 weeks and 3 months post intervention

Secondary outcome [13]

Healthcare Utilisation. A structured checklist identified: unplanned hospital visits and length of stay, emergency attendance, ambulance access, hospice and respite admission, imaging procedures, pathology procedures, access to healthcare professionals (e.g. general practitioner, nurse, medical oncologist, radiation oncologist, neurosurgeon, cancer nurse coordinator, physiotherapist, occupational therapist, social worker and psychologist), medications (prescribed and non-prescribed), parking costs and any out-of-pocket costs incurred for both carer and patient.

Timepoint [13]

Monthly (total of six months)

Eligibility

Key inclusion criteria

Primary caregivers of patients with high grade glioma who were undergoing chemotherapy,
radiotherapy or combined chemoradiotherapy and within 2 months of initial diagnosis.
Caregiver of patients currently attending the neurosurgical, medical or radiation oncology outpatient departments.
Sufficient understanding of verbal and written English language.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

None

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

No concealment procedures. Participants will be identified by clinical staff at neurosurgical, radiation oncology and medical oncology outpatient departments while treating the care-receiver with chemoradiotherapy for high grade glioma. Potential participants will be provided with an information brochure. If amenable to the study, the research nurse will contact the participant and organise delivery of full participant information and consent form and subsequently obtain consent.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

N/A

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2013

Actual

4/07/2013

Date of last participant enrolment

Anticipated

Actual

8/01/2014

Date of last data collection

Anticipated

Actual

28/07/2014

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Sir Charles Gairdner Hospital - Nedlands

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital

Address [1]

Hospital Avenue
Nedlands 6009
Western Australia

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

The Cancer Council of WA

Address [2]

15 Bedbrook Place, Shenton Park WA 6008, Australia

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Western Australian Cancer and Palliative Care Network, Department of Health Western Australia.

Address [3]

189 Royal Street East Perth WA 6004

Country [3]

Australia

Primary sponsor type

University

Name

Cancer and palliative research and evaluation unit, University of Western Australia

Address

University of Western Australia
35, Stirling Highway
Crawley 6009
Western Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

Curtin University

Address [1]

Faculty of Health Sciences, Curtin University, 7 Parker Place, Technology Park Bentley 6102 Western Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Hospital Ethics Committee

Ethics committee address [1]

HREC 
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands
WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2012

Approval date [1]

15/02/2013

Ethics approval number [1]

2012-186

Summary

Brief summary

High grade glioma (HGG) is a term used to encompass grade III anaplastic astrocytomas, oligodendrogliomas and glioblastoma multiforme. This is a rapidly terminal, progressive, and significantly debilitating group of diseases which robs patients of function, cognition, and personality, making this a highly distressing disease for patients, families and carers. In addition to the general cancer related caregiving issues, the impact of the disease on the patients’ ability to function leads to reduced quality of life, increased stress and carer burden for their caregiver . The diagnosis of a brain tumour is particularly stressful for carers because the prognosis is dire and life expectancy short. These carers report increased stress and distress levels and decreased quality of life compared to carers of patients with cancers with a good prognosis. There are more than 200 problems and burdens identified by caregivers, which fall under several categories including: physical health problems, social problems and information needs, emotional problems and burdens related to responsibilities and impact on daily life.
Psychosocial interventions for caregivers in a range of situations have been developed with various aims including improving caregiver understanding and ability to care, self-efficacy, quality of life, stress reduction, and improving communication and relationships in the family. There is a paucity of information regarding the role or effect of interventions addressing the unmet needs of caregivers of patients with HGG.
Thus far this group has carried out two investigations into the experience and needs of patients with HGG and their caregivers. The first was a qualitative study of the needs of patients with HGG and their caregivers. Caregivers described a time of rapid change and a steep learning curve where they struggled with caring for partners with major disabilities and not knowing where to seek additional support or assistance (Halkett et al. 2010; McConigley et al. 2010). The second was a quantitative study (SCGH HREC 2006-146) which examined the experiences of 100 patient-carer dyads at three time points during the disease trajectory: during combined chemoradiotherapy, and 3 and 6 months later. 31% of caregivers reported moderate distress (DT score 5-6) and 31% reported extreme distress (score 7-10). Caregivers also
reported significantly more distress than patients (mean 5.1 vs. 4.1; paired t test p=0.01). Caregiver distress was associated with higher scores on the general health questionnaire (r=0.61, p<0.001). The top 5 moderate/high caregiver unmet needs were: 1. accessing prognostic information; 2. accessing financial support and government benefits; 3. accessible hospital parking; 4. impact of caring on usual life; and 5. reducing stress in the patients’ life. These preliminary results will be presented in a poster at COSA in November 2012.
The development of our intervention is based on our preliminary data and the identification of several key components including the caregiver’s preparedness to care, sense of control, competence, self-efficacy, anxiety, depression and distress, social support, information, a sense of reward, meaningfulness, positive emotions, optimism, respite and relationship with the care-receiver. Our intervention is currently in the development phase and is aimed to cover all these areas. We are seeking support and advice regarding the development of the intervention from a variety of sources including medical oncologists, neurosurgeons, radiation oncologists, palliative care physicians, psychologists, social workers, nurses, experienced representatives from Carers WA and COGNO, as well as consumer representatives. The purpose of this project is to determine the feasibility and efficacy of this supportive-educational intervention for caregivers of patients with HGG.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Georgia Halkett

Address

Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845

Country

Australia

Phone

618 9266 1762

Fax

618 9266 1770

[email protected]

Contact person for public queries

Name

Jenny Clarke

Address

Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845

Country

Australia

Phone

+61 8 9266 1757

Fax

[email protected]

Contact person for scientific queries

Name

Prof Anna Nowak

Address

Department of Medical Oncology
Sir Charles Gairdner Hospital
Locked Bag 2012
Nedlands
WA 6009

Country

Australia

Phone

+61 8 9346 1222

Fax

N/A

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Permission was not sought from participants to make individual participant data available.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No additional documents have been identified.

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