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Trial registered on ANZCTR


Registration number
ACTRN12613000342718
Ethics application status
Not yet submitted
Date submitted
25/02/2013
Date registered
27/03/2013
Date last updated
27/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Lung INterdisciplinary Clinic (LINC): reducing biopsychosocial distress in patients with lung cancer and mesothelioma
Scientific title
The effectiveness of an outpatient interdisciplinary team in reducing biopsychosocial distress in patients with lung cancer and mesothelioma
Secondary ID [1] 282020 0
None
Universal Trial Number (UTN)
U1111-1139-8500
Trial acronym
LINC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 288466 0
Mesothelioma 288467 0
Condition category
Condition code
Cancer 288812 288812 0 0
Lung - Mesothelioma
Cancer 288813 288813 0 0
Lung - Non small cell
Cancer 288814 288814 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants attend an initial 1/2 hour session with an allied health professional for an assessment using the Distress Thermometer. This involves an assessment of the participant's overall distress and the problems which may be contributing to their distress. Following completion of this assessment the following interventions/referrals, described below, will be completed.

PRACTICAL PROBLEMS:

* Child care:
Social Worker (SW): Referral to Cancer Council practical support program, assistance to apply for child care rebate.

* Housing:
SW: Information & assistance with emergency accommodation, temporary accommodation for rural patients during treatment, applications to Homeswest & Residential Care
Occupational Therapist (OT): Equipment & home modifications

* Insurance/Financial:
SW: Assistance & advocacy in accessing income protection insurance, superannuation benefits, Centrelink payments, financial aid & referral to financial counselors

* Transportation:
SW: Referral to transport services for assistance, assistance with Australian Council for Rehabilitation Of the Disabled (ACROD)/Taxi User Subsidy Scheme (TUSS) applications

* Work/school:
SW: Liaison & advocacy with workplace/school e.g. coordinating medical certificates from the doctor, liaising with school counselors/chaplains for children.

* Treatment decisions:
Cancer Nurse Coordinator (CNC): Ensure patient & family are aware of all treatment options (including no treatment), provide written information & ensure adequate understanding of it, provide strategies to make a decision, refer to counseling services, inform & communicate with the treating team.


FAMILY PROBLEMS:

* Dealing with children:
SW: Counseling & support regarding communicating with children, referral to counseling services for children, assessing carer stress & providing practical assistance to young carers, child protection.

* Dealing with partner:
SW: Counseling & support regarding communicating with partner, referral to counseling services (e.g. Cancer Council, Western Australian Psycho-Oncology Service (WAPOS), Silver Chain Hospice Service (SCHS), referral to domestic violence services if applicable, assessing carer stress & providing practical assistance to partners/carers

* Ability to have children:
CNC: Identify if the treatment will affect fertility & provide information regarding the impact on fertility, refer to reproductive endocrinologist, inform treating team which may include delaying treatment.

* Family health issues:
CNC: Identify what the health issues are, refer appropriately
SW: Counseling & support to cope with this stress, inform/refer to practical services to assist the family member, referral to counseling services.


EMOTIONAL PROBLEMS:

* All problem items:
SW: Counseling & support, risk assessment of self harm, referral to counseling services, liaison with General Practitioner (GP)/treating doctor (in the case of mental health background/symptoms), liaison with existing community supports (e.g. psychiatrist, psychologist, chaplain, school counselor etc) & information regarding Solaris Centre.


SPIRITUAL/RELIGIOUS CONCERNS:

* ALL: Referral to spiritual services at Sir Charles Gairdner Hospital (SCGH) or linking in with own community spiritual group


PHYSICAL PROBLEMS:

* Appearance:
ALL: Referral to Look Good…Feel Better
SW: Counseling & support & referral to counseling services.

* Bathing/dressing:
SW: Referral to support services for assistance at home
OT: Provision of adaptive equipment such as shower chair or long handled sponge, referral for OT home visit to assess for rails or home modification, education on energy conservation strategies.

* Breathing:
SW: If anxiety related; counseling & support, referral to psychology services.
OT: Education on controlled breathing and/or relaxation exercises.
Physiotherapist (PT): Assessment of titration requirement of medically prescribed oxygen for physical activity & education of non pharmacological interventions in management of breathlessness, coughing & airway clearance.

* Changes in Urination:
PT: Assessment & management of continence in collaboration with Continence Management Team.
CNC: assess if related to disease or treatment. Refer back to treating team if required.

* Constipation:
CNC: assess cause of constipation, discuss some simple medication options and natural dietary options.

* Diarrhoea:
CNC: assess cause and give advice as appropriate.

* Eating:
Dietition (DT): Assessment of nutritional needs, nutritional status and diet. Provision of education and counseling for recommended foods/food preparation methods to achieve nutritional needs; management of nutrition-related side effects of treatment; access to nutritional supplements

* Fatigue:
OT: Education on energy conservation strategies, provision of adaptive equipment, referral for OT home visit, education on strategies to improve sleep.
PT: Exercise advice & prescription.

* Feeling Swollen:
OT: Upper limb lymphoedema management.
CNC: assess cause and liaise with medical team

* Fevers:
CNC: assess cause and direct patient to appropriate follow up (Accident and Emergency if greater than 38 degrees celcius and having treatment)

* Getting Around:
OT: Provision of equipment such as a shower chair, referral for OT home visit.
PT: Assessment of physical capacity to identify impairment, exercise advice & prescription, mobility assessment, education regarding optimising safe mobilisation & mobility aid prescription.

* Indigestion:
CNC: assess cause (medications, diet, treatments, other) discuss with appropriate team members.

* Memory/Concentration:
OT: Formal assessment of cognition, education on compensatory strategies to cope with cognitive changes, referral to outside services such as Memory Clinic, or Day Hospital OT, referral for OT home visit to look at appropriate set-up of home environment to promote safety.

* Mouth Sores:
CNC: assess cause and if on treatment. May need to see GP

* Nausea:
CNC: assess cause. Refer appropriately to treatment team (or appropriate nurses-radation oncology/medical oncology) or discuss medication regime for antiemetics and educate about how to improve symptoms.

* Nose dry/congested:
CNC: assess cause and discuss with appropriate team members


* Pain:
PT: Assessment & non pharmacological treatment interventions in appropriate cases.
CNC: assess pain, discuss with appropriate team members (treating doctors, GP, Silver Chain Hospice or Palliative Care Service), educate regarding current pain medications

* Sexual:
SW: Counseling & support, referral to specialist counseling services, referral to Menopause Clinic at King Edward Memorial Hospital (KEMH), liaison with GP/treating doctors

* Skin Dry/Itchy:
CNC: assess cause and discuss with appropriate team members. Simple skin care advice and education offered

* Sleep:
OT: Education on sleep hygiene strategies and appropriate set-up of sleep environment, provision of pressure relieving devices to increase comfort in lying.

* Substance abuse:
SW: Assessment of use & motivation for change, referral to rehabilitation services.

* Tingling in Hands/Feet:
OT: Provision of adaptive equipment.

OTHER PROBLEMS:

* Falls/Near Falls:
OT: Education on falls prevention, provision of adaptive equipment, referral for OT home visit to assess falls risks in the home.
PT: Exercise advice & prescription, mobility assessment regarding optimising safe mobilisation, falls prevention & mobility aid prescription.

* Discomfort in Sitting/Lying:
OT: Provision of appropriate pressure relieving devices and positioning advice.
PT: Assessment of discomfort & treatment interventions in appropriate cases.

* Driving:
SW: Referral to transport services.
OT: Referral for OT driving assessment for patients with a condition which may impair their ability to drive.

* Smoking:
OT: Advice and education regarding quitting smoking.

* Medications:
ALL: Information regarding webster packs & referral back to the medical team.
SW: Referral to medication prompt services.

* Completing household chores:
SW: Referral for in home support services.
OT: Advice regarding adaptive equipment

* Legal:
SW: Information regarding legal documents (including Will, Enduring Power of Attorney (EPA) Enduring Power of Guardianship (EPG), Advanced Health Directive (AHD), low cost legal services & Guardianship & Administration applications. Liaison & advocacy with the justice or immigration systems.

* Lack of information regarding diagnosis, treatment or follow up plan:
CNC: provide information on disease, staging or treatment as appropriate for patient. Ensure rural patients have options for treatment closer to home as appropriate. Educate and support patient throughout disease (progression or recurrence) as to treatment plan and aim.

* Weight Loss:
DT: Assessment of nutritional needs, nutritional status and diet. Provision of education and counseling for recommended foods/food preparation methods to achieve nutritional needs; management of nutrition-related side effects of treatment; access to nutritional supplements

Following the completion of all the required interventions for the participant (this will vary for each participant), a follow up Distress Thermometer with problem checklist and qualitative questionnaire will be completed within 1-7 days via telephone. Should participants have future conerns they will have access to he allied health team for the duration of the research (April 2013 - September 2013).

Intervention code [1] 286603 0
Early detection / Screening
Intervention code [2] 286604 0
Rehabilitation
Intervention code [3] 286810 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288955 0
Reduction in Distress and number of concerns, measured on the Distress Thermometer and problem checklist, of >1 point
Timepoint [1] 288955 0
A Baseline Distress Thermometer with problem checklist will be completed at initial contact. Following completion of all allied health interventions, as directed by the treating clinician, a repeat Distress Thermometer with problem checklist will be completed via phone between 1 and 7 days. For example the allied health intervention may include the fabrication of a custom made cushion for increasing comfort in sitting and improved positioning. The treating Occupational Therapist may complete this intervention within 1 hour with a follow up call in 3 days. Following the follow up call if no modifications are required, the Occupational Therapist will close the intervention for this participant. The repeat Distress Thermometer will occur 1-7 days post the closure of this participant's intervention. Should a participant recieve interventions from more than 1 health professional, follow up will occur following the completion of the last health professional to complete their intervention.
Secondary outcome [1] 301433 0
Satisfaction questionairre
Timepoint [1] 301433 0
Following completion of all allied health interventions, as directed by the treating clinician, a qualitative questionnaire to determine the participant's experience of the clinic will be completed via phone between 1 and 7 days. For example the allied health intervention may include the fabrication of a custom made cushion for increasing comfort in sitting and improved positioning. The treating Occupational Therapist may complete this intervention within 1 hour with a follow up call in 3 days. Following the follow up call if no modifications are required, the Occupational Therapist will close the intervention for this participant. The repeat Distress Thermometer will occur 1-7 days post the closure of this participant's intervention. Should a participant recieve interventions from more than 1 health professional, follow up will occur following the completion of the last health professional to complete their intervention.

Eligibility
Key inclusion criteria
All patients with lung cancer or mesiothelioma who are under the care of any/all medical oncologist, respiratory physician, radiation therapist, palliative care specialist at Sir Charles Gairdner Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
under 18 years of age, cognitive impairment, non-English speaking

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)
Potential participants will be identified as follows:
1. All new lung cancer patients discussed at the weekly Multidisciplinary Lung Cancer meeting will be invited to participate via letter and phone call.
2. All existing lung cancer patients can be referred by any clinical staff member.
3. Posters will be placed in the outpatient clinics and participants can self refer.

The lead investigator will provide eligible participants with the patient information sheet and explanation of all aspects of the research. The participants will be provided with a written copy of the consent form and will be requested to read the information sheet and consent form. Time to discuss participation with their next of kin/guardian will be provided.

No concealment procedures required as all receive assessment and treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation
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
Statistical methods / analysis
Comparisons between pre and post test will be made using standard analyses such as paired t-tests and linear mixed models. Demographic variables such as participants age, gender, living situation, participants diagnosis, years since diagnosis, stage of disease, current functional analysis via an Australian Modified Karnovky Performance Scale (AMKPS) will be considered as confounders.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
30/09/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 680 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 6427 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 286802 0
Hospital
Name [1] 286802 0
Sir Charles Gairdner Hospital
Country [1] 286802 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 285594 0
Other Collaborative groups
Name [1] 285594 0
Cancer and Palliative Research Evaluation Unit (CaPCREU)
Address [1] 285594 0
School of Surgery M507, UWA, 35 Stirling HWY, Crawley WA 6009
Country [1] 285594 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288870 0
Sir Charles Gairdner and Osbourne Park Group.
Ethics committee address [1] 288870 0
Ethics committee country [1] 288870 0
Date submitted for ethics approval [1] 288870 0
26/02/2013
Approval date [1] 288870 0
Ethics approval number [1] 288870 0
2012-207

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

Contacts
Principal investigator
Name 38122 0
Mrs Kellie Blyth
Address 38122 0
Occupational Therapy Department, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands WA 6009
Country 38122 0
Australia
Phone 38122 0
+610893462855
Fax 38122 0
+610893463599
Email 38122 0
kellie.blyth@health.wa.gov.au
Contact person for public queries
Name 38123 0
Kellie Blyth
Address 38123 0
Occupational Therapy Department, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands WA 6009
Country 38123 0
Australia
Phone 38123 0
+610893462855
Fax 38123 0
+610893463599
Email 38123 0
kellie.blyth@health.wa.gov.au
Contact person for scientific queries
Name 38124 0
Kellie Blyth
Address 38124 0
Occupational Therapy Department, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands WA 6009
Country 38124 0
Australia
Phone 38124 0
+610893462855
Fax 38124 0
+610893463599
Email 38124 0
kellie.blyth@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
No additional documents have been identified.