Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001552875
Ethics application status
Approved
Date submitted
16/09/2021
Date registered
15/11/2021
Date last updated
14/12/2021
Date data sharing statement initially provided
15/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A nurse-enabled, shared-care model between primary and acute care for prostate cancer survivors (the MOSES-Survivorship study)
Scientific title
A hybrid, implementation-effectiveness trial of a nurse-enabled, shared-care MOdel between primary and acute care for proStatE cancer Survivors (the MOSES-Survivorship study)
Secondary ID [1] 305246 0
None
Universal Trial Number (UTN)
U1111-1269-2753
Trial acronym
MOSES-Survivorship
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 323523 0
Condition category
Condition code
Cancer 321082 321082 0 0
Prostate
Public Health 321426 321426 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention (entitled: MOSES-Survivorship) has been developed through a co-design process with end-users (men with prostate cancer, general practitioners, practice nurses, cancer specialists, and cancer nurses). MOSES-Survivorship strategically uses prostate cancer specialist nurses (PCSN's) - an existing workforce embedded in the health system - to implement a shared, follow-up care model between acute cancer care centres and general practices for people diagnosed with prostate cancer. PCSN's are trained and supported to (1) engage all stakeholders (patients, families, general practitioners, specialists, and allied health) to take an active role in cancer survivorship care in a shared, follow-up care model; (2) ensure timely information exchange and negotiation of shared-responsibilities through multidisciplinary case conferencing (Medical Benefits Schedule MBS - Item 750); and (3) ensure general practitioners and practice nurses have access to a survivorship care plan and a range of evidenced-based tools and resources. The intervention explicitly provides shared-care (interchanging specialist and general practice appointments during follow-up cancer care for men with prostate cancer) and enhanced care (overlaying general practice appointments with specialist appointments during follow-up care), depending on the clinical needs of the men with prostate cancer who are randomised to the intervention.

During active surveillance (Group 1), at completion of curative intent treatment for localised prostate cancer defined as end of surgery or radiation therapy, whichever was delivered last (Group 2), or presenting with metastatic prostate cancer (Group 3), patients will be enrolled in the study, and randomised.

For the intervention:

1 x 30-60 minute face-to-face or telehealth Prostate Cancer Specialist Nurse consult with the participant 8+/-2 weeks post-enrolment to: 1) provide treatment summary; 2) provide survivorship patient education including a written survivorship booklet on “Living Well After Cancer” published by Cancer Council Australia; 3) co-develop a draft Survivorship Care Plan (SCP) including SMART goals (using motivational interviewing and self-efficacy techniques); and 4) provide a draft post-treatment shared-care follow-up appointment schedule. A draft SCP (including the treatment summary) will be provided to the participant via email or post and their nominated GP via GP clinic preferred communication system. Adherence to the nurse-led clinic and its components will be monitored using a nurse-led clinic checklist.

1 x 20–30-minute video/telephone case-conference between the Prostate Cancer Specialist Nurse and GP (+/- GP practice nurse) within 4 weeks of Specialist Cancer Nurse consult to finalise the SCP and negotiate the GP’s role in facilitating SCP SMART goals as well as seek agreement on the shared-care follow-up appointment schedule. Adherence to the GP case conference and its components will be monitored using a GP case conference checklist.

Up to 11 (depending on how far post-enrolment the patient is when they enter the study) alternating 6-monthly face to face or telehealth (as per clinician) patient appointments with cancer specialist or GP for 5 years will occur (for shared-care arrangements) or up to 11 additional 6-monthly face-to-face or telehealth (as per clinician) patient appointments with the GP in addition to the cancer specialist for 5 years will occur (for enhanced-care arrangements). At 5 years the patient will be discharged to the care of the GP. Appointment durations for the cancer specialist or the GP will vary depending on patient needs (approximately 10 to 30 minutes each).

More specifically:

5 x GP appointments at <12- (initial), 18-, 30-, 42- and 54- months post-enrolment for review of SCP, general health, screening/management of comorbidities, psychosocial health cancer treatment toxicities, cancer-related symptoms, chronic disease management planning, allied health referrals and physical examinations (if required/agreed). The GP appointments duration will vary depending on participant need. Additional appointments with the GP can be scheduled if clinically indicated. The GP will have direct telephone access to the Prostate Cancer Specialist Nurse in case of concerns or escalation for acute care review. Adherence to the minimum GP appointment schedule will be monitored using MBS data.

6 x cancer specialist appointments at 12-, 18-, 24-, 36-, 48- and 60-months post-enrolment for review, physical examination, and imaging. The cancer specialist appointments duration will vary depending on participant need. Additional appointments with the cancer specialists can be scheduled if clinically indicated. Adherence to the minimum specialist appointment schedule will be monitored by checking medical records and hospital appointment scheduling data.
Intervention code [1] 321640 0
Behaviour
Comparator / control treatment
Usual, specialist-led (only) follow-up care for men with prostate cancer (i.e., no provision of a nurse-led clinic, or nurse-enabled establishment of a survivorship care plan) - as per local hospital protocols.

During active surveillance (Group 1), at completion of curative intent treatment for localised prostate cancer defined as end of surgery or radiation therapy, whichever was delivered last (Group 2), or presenting with metastatic prostate cancer (Group 3), patients will be enrolled in the study, and randomised.

For the control/comparator:

Participants will receive standard follow-up care as per local hospital protocols, plus a written survivorship booklet on “Living Well After Cancer” published by Cancer Council Australia. The current follow-up arrangement is a specialist-led model as determined by the treating surgeons, medical oncologist, and radiation oncologist. Follow-up care will be offered up to 5 years post-enrolment. Follow-up adoption and adherence will be monitored using MBS/PBS service data, as well as annual audits of participant attendance to designated follow-up schedule appointments as per the tailored survivorship care plan.
Control group
Active

Outcomes
Primary outcome [1] 328867 0
Prostate Cancer Specific Quality of Life - (PCa QoL) - as measured through the Functional Assessment of Cancer Therapy - Prostate questionnaire (FACT-P).
Timepoint [1] 328867 0
Baseline, 6 months post-baseline, 12 months post-baseline (primary timepoint)
Secondary outcome [1] 400681 0
Cancer Survivor Unmet Care Needs as assessed by the Short Form Survivors Unmet Needs (SF-SUN) questionnaire.
Timepoint [1] 400681 0
Baseline, 6 months post-baseline, 12 months post-baseline.
Secondary outcome [2] 400698 0
Patient experience of care as assessed by the composite Patient Assessment of Care for Chronic Conditions (PACIC) questionnaire.
Timepoint [2] 400698 0
6 months post-baseline, 12 months post-baseline
Secondary outcome [3] 400699 0
Average weekday sitting time as measured in hours by a single item from the International Physical Activity Questionnaire short-form (IPAQ-S) questionnaire.
Timepoint [3] 400699 0
Baseline, 6 months post-baseline and 12 months post-baseline,
Secondary outcome [4] 400700 0
Usual fruit and vegetable intake as measured by two short dietary questions from the National Nutrition Survey questionnaire.
Timepoint [4] 400700 0
Baseline, 6 months post-baseline and 12 months post-baseline,
Secondary outcome [5] 400701 0
Financial Toxicity as measured by the composite Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy (COST-FACIT) questionnaire.
Timepoint [5] 400701 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [6] 400702 0
Unplanned hospital admissions as reported by patient self-report (Y/N) and verified with hospital medical records.
Timepoint [6] 400702 0
6 months and 12 months post-baseline
Secondary outcome [7] 400703 0
Satisfaction of care as measured by 0-10 numerical analogue scale (with 10 being the most satisfied and 0 being least satisfied).
Timepoint [7] 400703 0
12-months post-baseline
Secondary outcome [8] 400704 0
% model of care uptake among eligible patients as recorded by research screening and recruitment logs
Timepoint [8] 400704 0
End of Study
Secondary outcome [9] 400705 0
% eligible patients offered the MOSES-Survivorship as recorded by research screening and recruitment log
Timepoint [9] 400705 0
End of Study
Secondary outcome [10] 400706 0
% GPs agreeing to participate in shared-care arrangement as measured by completion (Y/N) of the GP Case Conference checklist designed specifically for the study.
Timepoint [10] 400706 0
End of Study
Secondary outcome [11] 400709 0
Completed survivorship care plan/components (Y/N) as measured by survivorship care plan developed specifically for this study
Timepoint [11] 400709 0
Retrospectively from GP case conference to end of study
Secondary outcome [12] 400710 0
Number of access of rapid referral back to acute care as measured by research records and verified with medical records
Timepoint [12] 400710 0
Retrospectively at 5 years (to study enrollment).
Secondary outcome [13] 400711 0
GP completion of chronic disease management plan (Y/N) as measured by Medicare Benefits Schedule (MBS) records
Timepoint [13] 400711 0
Retrospectively at 5 years (to study enrollment).
Secondary outcome [14] 400713 0
Health provider satisfaction as measured by structured interview
Timepoint [14] 400713 0
12 months post-study completion.
Secondary outcome [15] 400714 0
Cost-effectiveness as measured by the Assessment of Quality of Life - 8 Dimensions (AQoL-8D) questionnaire
Timepoint [15] 400714 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [16] 400715 0
Symptom burden as measured by the composite Memorial Symptom Assessment Scale (MSAS) Total score.
Timepoint [16] 400715 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [17] 400716 0
Distress from symptoms as measured by the composite Memorial Symptom Assessment Scale Global Distress Index (MSAS-GDI)
Timepoint [17] 400716 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [18] 400717 0
Average frequency, severity and distress associated with physical symptoms as measured by the composite Memorial Symptom Assessment Scale physical symptom subscale score (MSAS-PHYS)
Timepoint [18] 400717 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [19] 400718 0
Average frequency, severity and distress associated with psychological symptoms as measured by the composite Memorial Symptom Assessment Scale psychological symptom subscale score (MSAS-PSYCH)
Timepoint [19] 400718 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [20] 400719 0
Cancer-related fatigue as measured by composite Brief Fatigue Inventory (BFI) questionnaire global fatigue score.
Timepoint [20] 400719 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [21] 400720 0
Incidence of fatigue as measured by a single item (Y/N) on the Brief Fatigue Inventory (BFI) questionnaire.
Timepoint [21] 400720 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [22] 400721 0
Severity of fatigue as measured by composite Brief Fatigue Inventory (BFI) questionnaire fatigue severity score.
Timepoint [22] 400721 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [23] 400722 0
Fatigue interference as measured by composite Brief Fatigue Inventory (BFI) questionnaire fatigue interference score.
Timepoint [23] 400722 0
Baseline, 6 months post-baseline, 12 months post-baseline
Secondary outcome [24] 400723 0
Total physical activity as measured in minutes by the Active Australia Survey (AAS) questionnaire.
Timepoint [24] 400723 0
Baseline, 6 months post-baseline and 12 months post-baseline.
Secondary outcome [25] 400724 0
Total moderate physical activity as measured in minutes by the Active Australia Survey (AAS) questionnaire.
Timepoint [25] 400724 0
Baseline, 6 months post-baseline and 12 months post-baseline.
Secondary outcome [26] 400725 0
Total vigorous physical activity as measured in minutes by the Active Australia Survey (AAS) questionnaire.
Timepoint [26] 400725 0
Baseline, 6 months post-baseline and 12 months post-baseline.
Secondary outcome [27] 400726 0
Adherence (Y/N) with annual physical examination recorded from electronic medical records.
Timepoint [27] 400726 0
Annually until 5-years post-baseline
Secondary outcome [28] 400727 0
Comorbidity burden as assessed using the composite Self-Administered Comorbidity Questionnaire with additional items from the Charleston Comorbidity Index and comorbidity list.
Timepoint [28] 400727 0
Baseline, 12 months post-baseline
Secondary outcome [29] 400728 0
Adherence with prescribed hormone therapies (ADT and Anti-Androgen medications) as recorded from medical records.
Timepoint [29] 400728 0
Annually until 5-years post-baseline
Secondary outcome [30] 401023 0
Adherence to Prostate-Specific Antigen (PSA) monitoring schedule via medical and study record audits
Timepoint [30] 401023 0
Annually until 5-years post-baseline
Secondary outcome [31] 401024 0
Time to cancer recurrence and progression via medical records review
Timepoint [31] 401024 0
Annually until 5-years post-baseline
Secondary outcome [32] 402082 0
Adherence to cancer treatments via medical record and study record audits.
Timepoint [32] 402082 0
Annually until 5-years post-baseline
Secondary outcome [33] 402083 0
Completion (Y/N) of Case Conferencing with GP as measured by GP Case Conference checklist designed specifically for the study
Timepoint [33] 402083 0
Within 4 weeks after survivorship clinic (GP case-conference)
Secondary outcome [34] 402084 0
Duration (minutes) of Case Conferencing with GP as measured by GP Case Conference checklist designed specifically for the study
Timepoint [34] 402084 0
Within 4 weeks after survivorship clinic (GP case-conference)
Secondary outcome [35] 402085 0
Completion (Y/N) of the specialist cancer nurse-led survivorship clinic as measured by Clinic checklist designed specifically for the study
Timepoint [35] 402085 0
6-10 weeks post-baseline (survivorship clinic)
Secondary outcome [36] 402086 0
Duration (min) of the specialist cancer nurse-led survivorship clinic as measured by Clinic checklist designed specifically for the study
Timepoint [36] 402086 0
6-10 weeks post-baseline (survivorship clinic)
Secondary outcome [37] 402087 0
Number of GP visits as measured by MBS and patient self-report (as verified by medical records)
Timepoint [37] 402087 0
Retrospectively at 5 years (to study enrollment).
Secondary outcome [38] 402088 0
Number of Specialist visits as measured by MBS and patient self-report (as verified by medical records)
Timepoint [38] 402088 0
Retrospectively at 5 years (to study enrollment).

Eligibility
Key inclusion criteria
Men with confirmed adenocarcinoma of the prostate (i.e., men with prostate cancer), who have (a) localised prostate cancer and being monitored through active surveillance, (b) localised prostate cancer (low, intermediate, or high risk) and have completed their primary curative intent treatment (surgery or radiation therapy) within the past 3 years, or (c) have had a diagnosis of metastatic prostate cancer for at-least 3 months or more.

Men must be 18 years of age or older; be able or willing to identify a usual GP or General Practice; be ambulatory with a Eastern Co-operative Oncology Group (ECOG) performance status of 0 to 2; have access to a telephone; and be-able to speak and read English.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they do not have prostate cancer; present with severe mental, cognitive or physical conditions or other circumstance that would limit the patient’s ability to participate at the discretion of treating clinicians; are judged to have <6 months of life expectancy at the discretion of the treating cancer specialist (urologist/oncologist); or who are unable to provide consent.

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)
Randomisation will be performed centrally through Research Electronic Data Capture (REDCap).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification will occur by site, and based on which group the participant fits: (1) localised prostate cancer on active surveillance; (2) localised prostate cancer following curative-intent treatment (surgery or radiation therapy) within the past 3 years; and (3) diagnosed with metastatic prostate cancer for at-least 3 months or more. Participants will be randomised using random permuted blocks of different sizes (2, 4 ,6) assigning participants to the control or intervention arms within each strata.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary Outcome
Difference scores will be created to assess change from baseline for total FACT-P scale at 12 months, the analysis will be adjusted by baseline to account for regression to the mean effects. Two sided 95% confidence intervals will be estimated using bias-corrected and accelerated boostrapping. Equivalence will be judged by the boostrapped confidence interalls falling in the equivalence margin. If equivalence is rejected the confidence intervals will be interpreted to determine if the intervention performs better or worse than the control.

Secondary Outcomes
Generalized linear mixed models will be used to account for repeated measures, link functions will be choosen based on outcome distributions. Results will be presented as means differences, and relative risks and risk differences with boostrapped 95% confidence intervals. Results for HRQol variables will be displayed using forest plots with standardised differences to enable easy interpretation of equivalence margins. Non HRQol variables will be assessed with traditional superiority hypothesis tests as this study was not powered assess equivalence for categorical variables. Analyses will be conducted as intention-to-treat. We will also monitor the characteristics (i.e. cancer stage, Gleason score, age, comorbidities, and Socio-Economic Indexes for Areas) of patients recruited to intervention and control arms and adjust for any differences at the analysis stage. Missing data will be explored by using chi-square and t-test. If no patterns are evident, a full case analysis will be performed. Otherwise missing data will be imputed using multiple imputation.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/01/2022
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
30/04/2029
Actual
Sample size
Target
490
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 20481 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 20482 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 20483 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 35254 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 35255 0
5042 - Bedford Park
Recruitment postcode(s) [3] 35256 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 309619 0
Government body
Name [1] 309619 0
Department of Health
Country [1] 309619 0
Australia
Primary sponsor type
Individual
Name
Professor Raymond Chan
Address
Director, and Professor of Cancer Nursing
Caring Futures Institute
College of Nursing and Health Science
Flinders University,
Bedford Park, South Australia, 5042
Country
Australia
Secondary sponsor category [1] 310638 0
None
Name [1] 310638 0
Address [1] 310638 0
Country [1] 310638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309393 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309393 0
Ethics committee country [1] 309393 0
Australia
Date submitted for ethics approval [1] 309393 0
25/10/2021
Approval date [1] 309393 0
29/11/2021
Ethics approval number [1] 309393 0

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

Contacts
Principal investigator
Name 113998 0
Prof Raymond Chan
Address 113998 0
Director, and Professor Cancer Nursing
Caring Futures Institute
College of Nursing and Health Science
Flinders University
Bedford Park, South Australia, 5042
Country 113998 0
Australia
Phone 113998 0
+61 410 791 019
Fax 113998 0
Email 113998 0
raymond.chan@flinders.edu.au
Contact person for public queries
Name 113999 0
Raymond Chan
Address 113999 0
Director, and Professor Cancer Nursing
Caring Futures Institute
College of Nursing and Health Science
Flinders University
Bedford Park, South Australia, 5042
Country 113999 0
Australia
Phone 113999 0
+61 410 791 019
Fax 113999 0
Email 113999 0
raymond.chan@flinders.edu.au
Contact person for scientific queries
Name 114000 0
Raymond Chan
Address 114000 0
Director, and Professor Cancer Nursing
Caring Futures Institute
College of Nursing and Health Science
Flinders University
Bedford Park, South Australia, 5042
Country 114000 0
Australia
Phone 114000 0
+61 410 791 019
Fax 114000 0
Email 114000 0
raymond.chan@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.