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Trial registered on ANZCTR


Registration number
ACTRN12617000068369
Ethics application status
Approved
Date submitted
6/01/2017
Date registered
13/01/2017
Date last updated
13/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Randomised Controlled Trial of a Nurse-led Survivorship Intervention for Empowering Patients with Hodgkin's and Non-Hodgkin's Lymphoma after treatment: (The Engage Trial-Pilot)
Scientific title
A Pilot Randomised Controlled Trial of a Nurse-led Survivorship Intervention for Empowering Patients with Hodgkin's and Non-Hodgkin's Lymphoma after treatment: (The Engage Trial-Pilot)
Secondary ID [1] 290849 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
ENGAGE Trial (Pilot)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hodgkin's Lymphoma 301529 0
Non-Hodgkin's Lymphoma 301591 0
Condition category
Condition code
Cancer 301248 301248 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 301298 301298 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1: Nurse-led, tailored, survivorship care intervention using telehealth delivery

At 4 weeks following end of treatment (e.g. chemotherapy or radiotherapy), participants will be offered an initial 60 minute tailored nurse video consultation.
Subsequently, monthly 30 minute video consultation follow-up sessions at 8 weeks and 12 weeks.

During the 4 week consultation (60 minutes):
- Evidence-based Patient Education: this includes the provision of a booklet including evidence-based coping or management strategies, and available healthcare resources. The booklet is entitled "Post-treatment Wellness Booklet for Patients diagnosed with Hodgkin's and Non-Hodgkin's Lymphoma". This booklet is designed by the Cancer Nursing Professorial Precinct Team, Royal Brisbane and Women's Hospital in collaboration with Queensland University of Technology and the Leukaemia Foundation. The nurse will discuss specific components of the topic that are relevant to the patient as identified by the Distress Thermometer and Problem Checklist. The Distress Thermometer and Problem Checklist will be completed by the patient prior to the consultation.
- Treatment Summary and Survivorship Care Plan: The nurse will develop a post-treatment care plan in collaboration with the patient. In this care plan, it includes a treatment summary (details of lymphoma treatment received by the patient), a follow-up schedule; collaborative goal setting.
- Patient referrals (as appropriate): The nurse will also facilitate referrals for the patients to receive services as appropriate.

During the 8 and 12 week consultations (30 minutes each),
The survivorship care plan will be reviewed as informed by the Distress Thermometer and Problem Checklist completed by patients prior to the consultations. Patient education and referrals will also be facilitated accordingly if required.

- Log of all consultations will be kept by treating nurse
Intervention code [1] 296791 0
Behaviour
Intervention code [2] 296826 0
Treatment: Other
Comparator / control treatment
Group 2: Information only
Participants will be receiving a booklet including evidence-based coping or management strategies, and available healthcare resources. The booklet is entitled "Post-treatment Wellness Booklet for Patients diagnosed with Hodgkin's and Non-Hodgkin's Lymphoma". This booklet is designed by the Cancer Nursing Professorial Precinct Team, Royal Brisbane and Women's Hospital in collaboration with Queensland University of Technology and the Leukaemia Foundation.

Group 3: Usual care
Usual care at the sites currently do not receive any structured survivorship intervention at the end of treatment
Control group
Active

Outcomes
Primary outcome [1] 300659 0
Health Related Quality of Life - measured using the Functional assessment of Cancer therapy-lymphoma (FACT-Lym), which consists of a general questionnaire (27-item FACT-G) and also a 15-item lymphoma specific subscale
Timepoint [1] 300659 0
Measured at baseline and 3 months
Secondary outcome [1] 330531 0
Perceived unmet needs - measured using the Short-Form Survivor Unmet Needs Survey (SF-SUNS)
Timepoint [1] 330531 0
Measured at baseline and 3 months
Secondary outcome [2] 330532 0
Mood- measured using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of two separate scales for anxiety (HADS-A) and depression (HADS-D).
Timepoint [2] 330532 0
HADS- Measured at baseline and 3 months
Secondary outcome [3] 330533 0
Generic QoL- assessed using EuroQol -Five Dimensions (EQ-5D)
Timepoint [3] 330533 0
Measured at baseline and 3 months
Secondary outcome [4] 330534 0
Financial toxicity- measured using the FACIT-COST which is an 11 item subjective measure for financial toxicity
Timepoint [4] 330534 0
Measured at baseline and 3 months
Secondary outcome [5] 330535 0
Satisfaction of Care
A survey of satisfaction of care is given at 3 months and is on an 11-point scale. Simple free-text data will also be collected on which pre- and post- treatment care was useful and not useful to the patients from the patient's perspective
Timepoint [5] 330535 0
Measured at 3 months
Secondary outcome [6] 330538 0
Process Outcomes (for Intervention group ; GROUP 1 only)
A purposively sampled subset of video-recorded consultations will be qualitatively analysed. Conversation analysis will be used to study social interaction and the outcomes of this complex intervention
Timepoint [6] 330538 0
Video-recorded during the interventions
Secondary outcome [7] 330539 0
Cost evaluation
This will include intervention costs, hospital medical charts, medicare data and patient survey data. The first three categories are passively collected and the last category requires the patients to actively provide data.
Timepoint [7] 330539 0
Collected at baseline and 3 months
Secondary outcome [8] 330696 0
Distress- measured using the Distress Thermometer (DT)
Timepoint [8] 330696 0
DT- Measured at baseline, 4 weeks, 8weeks and 12 weeks

Eligibility
Key inclusion criteria
Patients within four weeks of completion of treatment with curative intent for Hodgkin's Lymphoma, or aggressive Non- Hodgkin's Lymphoma. Patients completing allogeneic hematopoietic stem cell transplantation, treatment completion will be defined as Day 100 (D100). Patients must be able to speak and read English. Patients must be 18 years of age or older and an ambulatory patient at the time of recruitment. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and also have access to the Internet and a smart device and/or computer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The presence of severe mental, cognitive or physical conditions that would limit the person’s ability to participate, or if they were previously enrolled into the study.

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)
Patients will be randomly allocated to one of three arms by an investigator who has no involvement in patient care by using a computer-generated table of random numbers. The three arms include the intervention group: nurse-led tailored survivorship care intervention, the 'information only' group, and the control group which will receive usual care. The allocation is concealed from the research nurse until after the patient has consented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomisation schedule is used to allocate treatment. The block randomisation schedule is held by the central registry in a 1:1:1 ratio. Block randomisation within centre will ensure even allocation to each treatment arm at each site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The patient data will be analysed by intention to treat using PASW (Version 22.0, SPSS).
Descriptive analysis will be performed for all clinical, demographic, and other risk factors collected at baseline. The mean scores of FACT-Lym, and a range of secondary outcome measures will be compared across the intervention, information only and control groups using Linear Mixed Effects Models to analyse the effect between groups from baseline to study completion at 3 months time. Qualitative analysis will involve using conversation analysis to identify recurrent patterns in the delivered interventions that may contribute towards the intervention outcome. Process factors identified through the qualitative analysis of this pilot study will be used to inform the development of a large-scale trial. Analysis will be undertaken by an experienced conversation analyst.

Economic analysis: Cost evaluation- this involves exploratory multivariable analyses using generalised linear equations . Analysis of the FACIT-COST and EQ-5D will use respective scoring algorithms and descriptive analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/01/2017
Actual
Date of last participant enrolment
Anticipated
31/07/2017
Actual
Date of last data collection
Anticipated
1/01/2018
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7226 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 14991 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 295281 0
Hospital
Name [1] 295281 0
Royal Brisbane and Women's Hospital
Country [1] 295281 0
Australia
Primary sponsor type
Individual
Name
Prof Raymond Chan
Address
Level 2, Nursing and Midwifery Research Centre, Building 34, Royal Brisbane and Women's Hospital, Butterfield Street, Herston, 4029, Queensland
Country
Australia
Secondary sponsor category [1] 294104 0
None
Name [1] 294104 0
Address [1] 294104 0
Country [1] 294104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296613 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 296613 0
HREC Office, Level 7, Block 7 RBWH
RGO Office, Level 4, UQCCR, RBWH
Butterfield Street, Herston Qld 4029
Ethics committee country [1] 296613 0
Australia
Date submitted for ethics approval [1] 296613 0
01/01/2017
Approval date [1] 296613 0
02/01/2017
Ethics approval number [1] 296613 0
HREC/16/QRBW/372

Summary
Brief summary
The aim is to assess the effectiveness and cost-effectiveness of a nurse-led, tailored survivorship care intervention using telehealth delivery, relative to ‘Information Only’ and ‘Usual Care’, for improving health-related quality of life (HRQoL) in people with Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma.

Who it focuses on: Patients within four weeks of completion of treatment with curative intent for HL, or aggressive NHL. Others include speaking and reading English; 18 years of age or older; an ambulatory patient at the time of recruitment; Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; and have access to the Internet and a smart device and/or computer.

Study Details:
Recruited patients will be randomly allocated to one of the three arms. . The intervention group will receive the nurse-led tailored Survivorship Care intervention between the last cycle of chemotherapy and four weeks post treatment completion for people who have completed their defined active treatment for Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma. In total, this group will receive three nurse-led consultations via video conferencing. The first consultation will be 60 minutes, involving the provision of treatment summary, evidence-based patient education, survivorship care plan, follow up schedule, and appropriate patient referrals. The second and third consultation will take 30 minutes each. These 30 minute consultations will focus on patient education and amendment to the care plan depending on the needs of the individual patient.

The ‘Information Only’ group will receive an evidence-based information booklet via post at the end of treatment. The booklet is entitled "Post-treatment Wellness Booklet for Patients diagnosed with Hodgkin's and Non-Hodgkin's Lymphoma". This booklet is designed by the Cancer Nursing Professorial Precinct Team, Royal Brisbane and Women's Hospital in collaboration with Queensland University of Technology and the Leukaemia Foundation.

The control group will receive usual care. Usual care is the absence of any structured survivorship intervention, involving traditional physician follow up.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 71490 0
Prof Raymond Chan
Address 71490 0
Level 2, Building 34, Royal Brisbane and Women's Hospital, Butterfield street, Queensland, 4029, Australia
Country 71490 0
Australia
Phone 71490 0
+61736462653
Fax 71490 0
Email 71490 0
[email protected]
Contact person for public queries
Name 71491 0
Raymond Chan
Address 71491 0
Level 2, Building 34, Royal Brisbane and Women's Hospital, Butterfield street, Queensland, 4029, Australia
Country 71491 0
Australia
Phone 71491 0
+61736462653
Fax 71491 0
Email 71491 0
[email protected]
Contact person for scientific queries
Name 71492 0
Raymond Chan
Address 71492 0
Level 2, Building 34, Royal Brisbane and Women's Hospital, Butterfield street, Queensland, 4029, Australia
Country 71492 0
Australia
Phone 71492 0
+61736462653
Fax 71492 0
Email 71492 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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