Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000442202p
Ethics application status
Submitted, not yet approved
Date submitted
11/03/2018
Date registered
28/03/2018
Date last updated
28/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A study exploring experiences and perceptions of the use of a comprehensive geriatric assessment in older haematology patient's with lymphoma or myeloma
Scientific title
A study exploring experiences and perceptions of the use of a comprehensive geriatric assessment in older haematology patient's with lymphoma or myeloma.
Secondary ID [1] 294376 0
None
Universal Trial Number (UTN)
U1111-1211-0707
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older adults 307005 0
Myeloma 307166 0
Lymphoma 307167 0
Condition category
Condition code
Cancer 306098 306098 0 0
Hodgkin's
Cancer 306215 306215 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 306216 306216 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 306217 306217 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The sole researcher, an Advanced Practice Haematology Nurse Specialist, will complete a Comprehensive Geriatric Assessment (CGA) with each study participant. As per the International Society of Geriatric Oncology guidelines a CGA covers the following:
A physical assessment ­including presence of health concerns,reviewing falls risk, current medicines,assessing nutritional needs and presence of pain.
Completing questionnaires assessing a participant's mental well­being, social and community activities and their perceived quality of life.
Determining a participant's ability to perform everyday activities such as washing and preparing meals will be assessed.
At the conclusion of the above assessments the participant will be provided with a summary of the results. If any additional medical issues are identified as part of the CGA, the researcher will discuss with the participant regarding consulting with their treating Haematologist, General Practitioner or other appropriate health professional. A management plan and follow up will ensure and be included in the their medical record.
This assessment will occur only once and may take up to two hours to complete depending upon the complexity of the participants health. It will take place within an outpatient clinic setting at a hospital closest to the participant's home.
Within two weeks the participants and the researcher will meet again. This meeting will involve a semi structured interview where participants will be asked about their impressions and thoughts regarding the assessment process. This interview will be audio recorded (with prior permission provided from the participants). Participants will receive a telephone call to remind them of the interview date and time.
The interview can take place either within the same outpatient clinic setting or if easier for the participants, the researcher will come to their home for this encounter. The interview is likely to take up to one hour but this will depend upon the discussion and participants insights. The study participants will have completed the study once the interview is finished.
Intervention code [1] 300599 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305130 0
Older person's experiences and perceptions during and after receiving a Comprehensive Geriatric Assessment
This is assessed through completing a CGA with participants at one time point and then interviewing them at a second time point. The interview will be semi-structured allowing the participants an opportunity to describe their experiences and insights about the geriatric assessment process.
Timepoint [1] 305130 0
Interview will occur within two weeks after the comprehensive geriatric assessment has been completed.
Secondary outcome [1] 344283 0
Perceptions of the CGA will be assessed by the following process:
Each interview will be audio recorded (after signed informed consent from the participants).
The interviews will be transcribed by the sole researcher.
The content of each interview will be analysed using the below process::
1. Initial coding- each transcript will be read through with line by line coding applied. Notes will be made after reading each line of text indicating potential codes.
2. Focused coding and formation of categories- each transcript will be re-read and the above initial codes further synthesised. This will include exploring differences or similarities between text used, combining the initial codes if similar and potentially expanding upon others. Tentative categories will be developed from the grouping together of similar codes.
The above two steps will develop over the course of study, with the potential for new codes being formed after each interview. It is also likely earlier analysed text could be reviewed more than once.
3. Memos-memo writing by the researcher begins early in the study. This will be a personal account of what is influencing the formation of the codes and categories.
4. Theoretical categories -this is an ongoing process influenced by the above steps and interaction with data collected. Categories are potential ways of defining participant’s experiences or their perspectives.
Timepoint [1] 344283 0
Initial data analysis will be undertaken following each interview. Upon completion of all interviews, categories will be examined for differences or similarities with the aim of developing theoretical propositions about the participant’s experiences and insights

Eligibility
Key inclusion criteria
• Age greater than 70 years
• Diagnosis of either Lymphoma or Myeloma
• Lymphoma patients will have completed chemotherapy within the last three years and either be in remission or have stable disease for at least three months
• Myeloma patients will have completed initial chemotherapy and/or be on a maintenance therapy program but have stable disease for at least three months
• Signed informed consent
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Newly diagnosed lymphoma or myeloma
• Have progressive lymphoma or myeloma requiring either further active therapy or be entering palliative phase of care management
• Unable to give informed consent
• Not able to comply with study procedures and/or follow up

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study involves assessing older haematology patients and interviewing them about their experiences.Its aim is to learn more about older peoples experiences, perceptions and insights.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a qualitative exploratory study the results will be descriptive and interpretive of the participant’s experiences. Demographic data and CGA results will be collated and analysed using the relevant assessments’ guidelines.
No sample size calculation is relevant however it is planned to recruit up to ten participants

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/04/2018
Actual
Date of last participant enrolment
Anticipated
4/02/2019
Actual
Date of last data collection
Anticipated
18/02/2019
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 9670 0
New Zealand
State/province [1] 9670 0
Otago/Southland

Funding & Sponsors
Funding source category [1] 298946 0
Hospital
Name [1] 298946 0
Dunedin Hospital
Country [1] 298946 0
New Zealand
Primary sponsor type
Individual
Name
Rosemary Hoyt
Address
Dunedin Hospital
Southern Blood and Cancer Service
Private Bag 1921
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 298159 0
None
Name [1] 298159 0
Address [1] 298159 0
Country [1] 298159 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299883 0
Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 299883 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 299883 0
New Zealand
Date submitted for ethics approval [1] 299883 0
17/03/2018
Approval date [1] 299883 0
Ethics approval number [1] 299883 0

Summary
Brief summary
Older people who are diagnosed with haematological cancers such as lymphoma or myeloma often have other health problems as well as their cancer. These health problems can impact on their ability to cope with chemotherapy side effects and may affect their recovery.
The International Society for Geriatric Oncology recommends the use of a Comprehensive Geriatric Assessment (CGA) around the time of a cancer diagnosis. This assessment includes several tests examining a persons mood, memory, ability to undertake everyday activities, risk of falls as well as a review of their physical health and current medicines. By conducting a CGA, actual or potential health problems may be detected and if managed early, side effects from chemotherapy can be reduced and make it easier for older people to recover. However there is little information about how older people view these assessments and if they find them useful.
We are proposing a small qualitative study to explore the older person's perspective regarding this type of geriatric assessment and how they experience it. This study may potentially improve how older people are assessed at time of diagnosis or during cancer treatment. It may also lead on to an improved understanding of how older people with a cancer may perceive geriatric assessment testing. Older people, for the purposes of this study, will be defined as those adults seventy years or older.
This research involves participants completing a comprehensive geriatric assessment with the researcher at one time point then meeting with the researcher a second time. At this second meeting the participant will be interviewed about their impressions and insights about the assessment process. Interview results will be analysed using an interpretative approach where participants responses and insights will be examined for common meanings, patterns and themes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81858 0
Ms Rosemary Hoyt
Address 81858 0
Southern Blood and Cancer Service
Private Bag 1921, Dunedin Hospital, Dunedin 9054
Country 81858 0
New Zealand
Phone 81858 0
+64 2 78363118
Fax 81858 0
Email 81858 0
[email protected]
Contact person for public queries
Name 81859 0
Ms Rosemary Hoyt
Address 81859 0
Southern Blood and Cancer Service
Private Bag 1921, Dunedin Hospital, Dunedin 9054
Country 81859 0
New Zealand
Phone 81859 0
+64 2 7836 3118
Fax 81859 0
Email 81859 0
[email protected]
Contact person for scientific queries
Name 81860 0
Ms Rosemary Hoyt
Address 81860 0
Southern Blood and Cancer Service
Private Bag 1921, Dunedin Hospital, Dunedin 9054
Country 81860 0
New Zealand
Phone 81860 0
+64 2 7836 3118
Fax 81860 0
Email 81860 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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