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Trial registered on ANZCTR


Registration number
ACTRN12615000530527
Ethics application status
Approved
Date submitted
14/05/2015
Date registered
27/05/2015
Date last updated
19/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Care After Lymphoma (CALy) Trial: A phase II pilot randomised controlled trial of a lymphoma nurse-led model of survivorship care
Scientific title
A randomised controlled trial testing the effect of a pilot nurse-led lymphoma survivorship clinic with lymphoma survivors to decrease the number of unmet informational needs to reduce anxiety, stress and to increase self-empowerment
Secondary ID [1] 286764 0
Nil
Universal Trial Number (UTN)
U1111-1169-7131
Trial acronym
Care After Lymphoma (CALy) Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma
295059 0
Informational and practical needs 295060 0
Depression 295138 0
Anxiety 295139 0
Stress 295140 0
Self-empowerment 295142 0
Condition category
Condition code
Cancer 295311 295311 0 0
Hodgkin's
Cancer 295312 295312 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 295313 295313 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a nurse-led lymphoma survivorship clinic. A structured face-to-face interview of 1 hour with the survivorship cancer nurse coordninator will discuss and assess participant self-reported: informational and practical issues and concerns; depression, anxiety, stress; coping; and patient empowerment. The first clinic will occur at 3 months after treatment completion. A survivorship care plan will be completed with the participant and include the main potential late effects of treatment and the health care provider that will assess and follow up on these. It will record the participants 3 main health concerns and 3 health goals. The treatment summary will be completed prior to the clinic and the information verified and explained to the participant at this first interview. According to the needs identified by the participant, a tailored resource pack of information and community support details will be targeted towards their main concerns and health goals. The participant will attend the survivorship clinic 3 and 6 months after the first clinic (baseline). It will involve discussion of any further self-reported issues or concerns and the already identified concerns and health goals. This may take up to an hour.
Intervention code [1] 291849 0
Rehabilitation
Comparator / control treatment
Control – usual care. The control group will continue usual follow-up care with their haematologist. They will have the same instruments administered to them at baseline, time 1(3 months) and 2 (6 months) after baseline. At time 1 and 2 the instruments will be sent to the control group along with a reply paid envelope for sending them back. If questionnaires are not returned the participant/s will be contacted by telephone after 2 weeks to encourage return.
Control group
Active

Outcomes
Primary outcome [1] 295046 0
Proportion of participants with a self-reported decrease in unmet informational and practical needs. Measured with Short Form Survivors Unmet Needs Survey (SF-SUNS).
Timepoint [1] 295046 0
Baseline, and at 3 and 6 months after intervention commencement
Primary outcome [2] 295047 0
Proportion of participants with a self-reported decrease in depression, anxiety, stress. This composite outcome will be measured with Depression Anxiety Stress Scale (DASS21).
Timepoint [2] 295047 0
Baseline, and at 3 and 6 months after intervention commencement
Primary outcome [3] 295048 0
Proportion of participants with a self-reported increase in coping and self-empowerment. This composite outcome will be measured with Patient Empowerment scale (PES) and Mini Mental Adjustment to Cancer Scale (Mini-MAC).
Timepoint [3] 295048 0
Baseline, and at 3 and 6 months after intervention commencement
Secondary outcome [1] 314667 0
Perceived efficacy and value of the nurse-led lymphoma survivorship clinic. Semi-structured 1 hour telephone interviews with subset of intervention participants.
Timepoint [1] 314667 0
6 months after intervention commencement
Secondary outcome [2] 314668 0
GP evaluation of the survivorship care plan treatment summary to improve care, management and communication. An evaluation questionnaire designed for this study will be sent with a reply paid envelope and should take no more than 10-15 minutes to complete.
Timepoint [2] 314668 0
6 months after intervention commencement

Eligibility
Key inclusion criteria
Able to understand, read and write English
Pathologically confirmed new diagnosis of Hodgkin or non-Hodgkin lymphoma
Completed first line curative intent chemotherapy treatment or second line curative intent autologous transplant within the previous three months
No evidence of lymphoma on PET scan
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of other haematological malignancy
Did not undergo chemotherapy treatment
Further treatment or follow-up at another hospital
Undergoing active treatment
Acute mental health condition that will preclude informed consent
Intellectually disabled
Comorbid condition that requires at least monthly visits with genral practitioner (GP)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After consent and baseline measures, participants will be given an opaque envelope they will open. It contains an individual number and group allocation. The envelopes have been consecutively numbered and are distributed to consenting participants in this order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers using a four digit sequence have been generated and linked to group allocation by an independent statistician. A hard copy of each individual number and group has been sealed in an opaque envelope by an independent member of the research team to ensure confidentiality.
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
A consecutive sample of 60 participants will be recruited, 30 to each study group. As a pilot RCT, a sample size calculation is not required. 30 participants in each group will ensure an adequate measure of variability that will enable the generation of sample sizes for future large scale RCTs with this participant group.
To undertake a test-retest reliability measure on the SF-SUNS (Short Form Survivor Unmet Needs Survey) will require a sample size of 40 participants. This will involve administering the SF-SUNS instrument on two consecutive occasions no more than five days apart.
Ten participants will be selected for qualitative interviews after their six-month nurse-led haematology survivorship clinic visit. The number of GPs sent a survivorship care plan treatment summary and evaluation will be a maximum of 30 to reflect the intervention group numbers.
Data Analysis for quantitative data will use univariate and multivariate statistical techniques with SPSS data analysis software. Descriptive statistics will be used for demographic variables. Two-tailed analysis significance level is set at 0.05 for all tests. Differences between intervention and control groups and between baseline measurements and at each time point will use one-way analysis of variance [ANOVA] for normal distribution and repeated measures ANOVA to analyse the entire series of measurements at each time point. Confidence intervals will reflect the contrast between groups. Test-retest reliability of SF-SUNS instrument will use an intra-class correlation random effect model.
Qualitative data will be analysed using QSR NVivo qualitative analysis software. Content analysis will identify common themes and patterns within interview data and the open-ended questions on GP evaluation form.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2015
Actual
3/08/2015
Date of last participant enrolment
Anticipated
28/02/2017
Actual
14/03/2017
Date of last data collection
Anticipated
30/09/2017
Actual
5/10/2017
Sample size
Target
60
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3792 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 9673 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 291269 0
University
Name [1] 291269 0
University of Notre Dame Australia, Fremantle Campus
Country [1] 291269 0
Australia
Primary sponsor type
University
Name
University of Notre Dame Australia, Fremantle Campus
Address
19 Mouat Street, Fremantle, WA 6959
Country
Australia
Secondary sponsor category [1] 289942 0
Government body
Name [1] 289942 0
Western Australia Cancer and Palliative Care Network
Address [1] 289942 0
189 Royal Street, East Perth. 6004 Western Australia
Country [1] 289942 0
Australia
Other collaborator category [1] 278466 0
Hospital
Name [1] 278466 0
Sir Charles Gairdner Hospital
Address [1] 278466 0
Hospital Avenue, Nedlands 6009, Western Australia
Country [1] 278466 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292828 0
Sir Charles Gairdner Hospital HREC
Ethics committee address [1] 292828 0
Ethics committee country [1] 292828 0
Australia
Date submitted for ethics approval [1] 292828 0
Approval date [1] 292828 0
25/03/2015
Ethics approval number [1] 292828 0
2015-020
Ethics committee name [2] 292829 0
University of Notre Dame Australia HREC
Ethics committee address [2] 292829 0
Ethics committee country [2] 292829 0
Australia
Date submitted for ethics approval [2] 292829 0
Approval date [2] 292829 0
26/02/2015
Ethics approval number [2] 292829 0
015007F

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57246 0
Prof Leanne Monterosso
Address 57246 0
The University of Notre Dame Australia
PO Box 1225 Fremantle, WA 6959
Country 57246 0
Australia
Phone 57246 0
+ 61 8 9433 0103
Fax 57246 0
+ 61 8 9433 0227
Email 57246 0
Leannne.Monterosso@nd.edu.au
Contact person for public queries
Name 57247 0
Karen Taylor
Address 57247 0
WA Cancer and Palliative Care Network
189 Royal Street East Perth. WA 6004
Country 57247 0
Australia
Phone 57247 0
+ 61 8 92220202
Fax 57247 0
Email 57247 0
Karen.Taylor@health.wa.gov.au
Contact person for scientific queries
Name 57248 0
Karen Taylor
Address 57248 0
WA Cancer and Palliative Care Network
189 Royal Street East Perth. WA 6004
Country 57248 0
Australia
Phone 57248 0
+ 61 8 92220202
Fax 57248 0
Email 57248 0
Karen.Taylor@health.wa.gov.au

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
No documents have been uploaded by study researchers.

Documents added automatically
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