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Trial registered on ANZCTR


Registration number
ACTRN12610000724077
Ethics application status
Approved
Date submitted
17/08/2010
Date registered
31/08/2010
Date last updated
31/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Conversations with your doctor: Making the most of medical consultations for patients with advanced incurable cancer and their carers
Scientific title
Improving communication and quality of life (QOL) at the end of life: A randomised controlled trial of a multifocal communication intervention for patients with advanced incurable cancer, carers and doctors.
Secondary ID [1] 252440 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Communication about prognosis and end of life care planning in the advanced cancer context 257953 0
Condition category
Condition code
Public Health 258120 258120 0 0
Health service research
Cancer 258152 258152 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The multifocal communication intervention consists of two programs, one targeting the patient and their carer and another targeting the oncologist:

1) Patient and Carer Communication Support Program - consists of one face-to-face meeting (approx. 90 mins) and one telephone follow-up (approx. 30 mins) with a specially trained nurse.

- The face-to-face meeting will encourage the patient and carer to reflect on and discuss their goals, wishes, preferences and concerns about care into the future and to discuss the challenges inherent in asking questions or communicating concerns with the patient's oncologist. They will also be guided through a new Question Prompt List targeting discussion of prognosis and end of life issues and assisted in selecting and prioritising any questions they may wish to ask in future consultations. Strategies to overcome barriers to asking these questions and to communication in the health care context in general will also be discussed. This face-to-face meeting will take place approximately 1 week prior to the audio-taped oncology consultation.

- The telephone follow-up will review the patient's next oncology consultation after the face-to-face meeting with the nurse to identify any new barriers or challenges, discuss solutions to these and further assist in identifying and prioritising questions to ask at future consultations. It will be completed approximately 1 week after the audio-taped consultation.

2) Oncologist Consultation Skills Training Program - consists of 2 components, an academic detailing session and facilitated role-play with a simulated patient, delivered in one one-on-one session by an experienced communication facilitator (approx. 90 mins).

- The academic detailing will review evidence and methodology for calculating prognosis and evidence and strategies for discussing life expectancy and end of life issues. A 'take home' pack will also be provided consisting of current literature and a DVD modelling ideal communication behaviours and responses to challenging questions from the Question Prompt List.

- The facilitated role-play will simulate a consultation with a patient who has advanced incurable cancer. The oncologist will be encouraged to practice the skills discussed in the academic detailing whilst the simulated patient will ask questions and react realistically to the oncologist's responses and behaviours.
Intervention code [1] 257005 0
Treatment: Other
Comparator / control treatment
Patients/Carer dyads in the control arm will receive standard care from their oncologist and will not complete any elements of the Communication Support Program.
Control group
Active

Outcomes
Primary outcome [1] 258981 0
Patient - achievement of information and decision role preferences (questionnaire - adapted from the Cassileth Information Styles and Degner Involvement questionnaires)
Timepoint [1] 258981 0
Baseline (identification of preferences), one month post audio-taped oncology consultation (achievement of preferences)
Primary outcome [2] 258982 0
Patient - communication self-efficacy (Perceived Efficacy in Patient Physician Interaction (PEPPI) questionnaire)
Timepoint [2] 258982 0
Baseline, post face-to-face session (intervention arm)/2 weeks post baseline (control arm), 1 month post audio-taped oncology consultation, 3 monthly follow-up until death
Primary outcome [3] 258983 0
Patient - quality of life (Functional Assessment of Cancer Therapy - General Version (FACT-G) version 4 questionnaire)
Timepoint [3] 258983 0
Baseline, 1 month post audio-taped oncology consultation, 3 monthly follow-up until death
Secondary outcome [1] 265210 0
Patient, Carer, Oncologist - communication during consultation (Qualitative content analysis of communication during consultation)
Timepoint [1] 265210 0
audio-taped consultation (control - next after baseline assessment, intervention - next after face-to-face meeting)
Secondary outcome [2] 265211 0
Patient, Carer, Oncologist - satisfaction with interventions (Likert scale questionnaire)
Timepoint [2] 265211 0
Patient & Carer - post face-to-face session, 1 month post audio-taped oncology consultation
Oncologist - post completion of patient cohort recruitment
Secondary outcome [3] 265212 0
Oncologist - comfort with discussing prognosis and end of life issues (Likert scale questionnaire)
Timepoint [3] 265212 0
Baseline, post completion of patient cohort recruitment
Secondary outcome [4] 265213 0
Oncologist - comfort with sharing decision making about care (Likert scale questionnaire)
Timepoint [4] 265213 0
Baseline, post completion of patient cohort recruitment
Secondary outcome [5] 265214 0
Patient - supportive care unmet needs (Supportive Care Needs Survey Short Form 34 (SCNS-SF34) questionnaire)
Timepoint [5] 265214 0
Baseline, 1 month post audio-taped oncology consultation, 3 monthly follow-up until death
Secondary outcome [6] 265215 0
Patient - hopes for treatment and preferences for future interventions (questionnaire)
Timepoint [6] 265215 0
Baseline, 1 month post audio-taped oncology consultation, 3 monthly follow-up until death
Secondary outcome [7] 265216 0
Patient - understanding of prognosis and treatment options (questionnaire)
Timepoint [7] 265216 0
1 month post audio-taped oncology consultation
Secondary outcome [8] 265217 0
Patient - evaluation of doctor's communication (Likert scale questionnaire)
Timepoint [8] 265217 0
1 month post audio-taped oncology consultation
Secondary outcome [9] 265218 0
Carer - quality of life (SF-36v2 Health Survey)
Timepoint [9] 265218 0
Baseline, 1 month post audio-taped oncology consultation, 3 monthly follow-up until patient's death
Secondary outcome [10] 265219 0
Carer - achievement of information and decision role preferences in patient's care (questionnaire - adapted from the Cassileth Information Styles and Degner Involvement questionnaires)
Timepoint [10] 265219 0
Baseline (identification of preferences), one month post audio-taped oncology consultation (achievement of preferences)
Secondary outcome [11] 265220 0
Carer - knowledge of patient's hopes for treatment and preferences for future interventions (questionnaire)
Timepoint [11] 265220 0
Baseline, 1 month post audio-taped oncology consultation, 3 monthly follow-up until patient's death
Secondary outcome [12] 265221 0
Carer - communication self-efficacy (Perceived Efficacy in Patient Physician Interaction (PEPPI) questionnaire - adapted for carers)
Timepoint [12] 265221 0
Baseline, post face-to-face session (intervention arm)/2 weeks post baseline (control arm), 1 month post audio-taped oncology consultation, 3 monthly follow-up until patient's death
Secondary outcome [13] 265222 0
Carer - Quality of patient's death and dying experience (QODD Interview)
Timepoint [13] 265222 0
2 months post patient's death
Secondary outcome [14] 265223 0
Details of medical care and significant interventions in the last month of the patient's life from medical records
Timepoint [14] 265223 0
Immediately following notification of patient's death

Eligibility
Key inclusion criteria
Participants must be patients, carers or oncologists at participating hospitals. All must be over 18 years of age , have a good comprehension of the English language and be able to give informed consent.
- Patients must be current patients of participating oncologists who have advanced, incurable cancer with a life expectancy of between 2 and 12 months.
- Carers must be identified as the primary carers of a patient enrolled in the study.
- Oncologists must be medical or radiation oncologists.

NOTE: Patients will NOT be excluded from participating if they do not nominate a carer to the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and/or young people (i.e. <18 years) have been excluded as communication regarding end of life issues would be substantially different for this age group. People with intellectual or mental impairment have also been excluded as active participation in the intervention would be required, together with self-report measurement. The application of the intervention to these groups lies beyond the scope of the current study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of patient/carer dyads to the treatment (communication support program) and control arms will be performed once baseline assessment has been completed. Study personnel will open the next envelope in sequence for the patient's oncologist to determine randomisation once they have received the patient's and carer's completed baseline questionnaires.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation codes will be generated by a statistician blinded to the identity of participants, stratified by oncologist, using computer generated random number tables. Randomisation codes will be placed in sequentially numbered sealed opaque envelopes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Oncologist participants will all receive the consultation skills training program component of the intervention. Participating oncologists will each recruit 10 to 20 of their patients to the study for a pre-training program cohort after which they will receive the training program. They will then recruit a further 10 to 20 patients for a post-training program cohort. This pre-post design for oncologist participants, coupled with the randomised allocation of patient/carer dyads to the communication support program, will allow the effects of each individual program as well as the multifocal intervention to be examined.
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257465 0
Government body
Name [1] 257465 0
National Health and Medical Research Council
Address [1] 257465 0
Level 5, 20 Allara St
Canberra City ACT 2601
Country [1] 257465 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Centre for Medical Psychology & Evidence-based Decision-making
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 256691 0
None
Name [1] 256691 0
Address [1] 256691 0
Country [1] 256691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259490 0
Sydney South West Area Health Service (SSWAHS) Ethics Review Committee (Royal Prince Alfred Hospital (RPAH) Zone)
Ethics committee address [1] 259490 0
Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Rd
CAMPERDOWN NSW 2050
Ethics committee country [1] 259490 0
Australia
Date submitted for ethics approval [1] 259490 0
Approval date [1] 259490 0
Ethics approval number [1] 259490 0

Summary
Brief summary
This study is aimed at evaluating a multifocal communication intervention incorporating a nurse-led patient and carer communication support program and and oncologist consultation skills training program. The intervention is intended to improve communication about life expectancy and end of life issues between patients with advanced incurable cancer, their carers and their oncologists in the final year of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31519 0
Address 31519 0
Country 31519 0
Phone 31519 0
Fax 31519 0
Email 31519 0
Contact person for public queries
Name 14766 0
Adam Walczak
Address 14766 0
Centre for Medical Psychology & Evidence-based Decision-making
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney NSW 2006
Country 14766 0
Australia
Phone 14766 0
+612 9036 9192
Fax 14766 0
Email 14766 0
adam.walczak@sydney.edu.au
Contact person for scientific queries
Name 5694 0
Prof Phyllis Butow
Address 5694 0
Centre for Medical Psychology & Evidence-based Decision-making
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney NSW 2006
Country 5694 0
Australia
Phone 5694 0
+612 9351 2859
Fax 5694 0
Email 5694 0
phyllis.butow@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results