Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000025730
Ethics application status
Approved
Date submitted
16/11/2021
Date registered
13/01/2022
Date last updated
30/11/2023
Date data sharing statement initially provided
13/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Prostate Cancer Survivorship Essentials for Men with Prostate Cancer on Androgen Deprivation Therapy (ADT) (PCEssentials Hormone Therapy Study)
Scientific title
Prostate Cancer Survivorship Essentials for Men with Prostate Cancer on Androgen Deprivation Therapy (ADT): An Effectiveness-Implementation Hybrid (Type 1) Trial of a Tele-Based Nurse-Led Survivorship Care Intervention
Secondary ID [1] 305810 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgen Deprivation Therapy in Prostate Cancer 324326 0
Condition category
Condition code
Cancer 321818 321818 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A tele-based nurse-led survivorship care intervention (PCEssentials).

The PCEssentials intervention is a five session psychoeducation program, delivered by trained prostate cancer specialist nurses via telehealth, which includes four sessions over three months and a booster session at six months post recruitment. Each session is approximately 60 minutes in duration and covers treatment education, psychoeducation, problem solving, self-management, and communication tailored to the man's needs. Distress screening and symptom/side-effect assessment are also undertaken in each session.

Resources include a copy of Facing the Tiger (2020), Facing the Tiger which provides practical strategies to help cope with the emotional and psychological stress of living with prostate cancer, and readily available resources from the Prostate Cancer Foundation of Australia.

Men in the intervention group will also be provided with reccommendations for a home-based exercise activity program and be encouraged to seek at least one planning session with an Accredited Exercise Physiologist (AEP) within their treatment team, which may be by telehealth as appropriate. The frequency and duration of exercise sessions will be dependent on the man's need/ability at the time of the intervention.

For example, participants will be asked to accumulate 70 to 150 minutes per week of moderate to vigourous aerobic exercise and two or more resistance training sessions each week. This will typically involve exercising on most if not every day each week for a minimum of 20 minutes. For the aerobic exercise sessions a combination of moderate intensity continuous training (MICT) as well as high intensity interval training (HIIT) will be prescribed using modalities such as walking/jogging, cycling, swimming. The resistance training prescription will involve between six and eight exercises each session involving all of the major muscle groups of the body. For example, squat, lunge, push-up, bent over row, shoulder press, abdominal crunch, prone back extension. The resistance training prescription will be tailored to the individual participant to account for any musculoskeletal issues and availability of equipment.

An already developed cloud-based exercise prescription and monitoring platform (the Technogym MyWellness platform. https://mywellness.com/) will be used to support the men to exercise and provide feedback to the nurse specialist. Participants will also be provided with online progress reports, resources and forms for education and motivation, including a weekly wellness check. The nurse specialist will encourage maintenance of exercise including both aerobic and resistance training as per Australian exercise medicine for cancer guidelines with referral to the AEP if required.

Treatment fidelity: The intervention is manualised and intervention nurses will complete a checklist of components to be delivered at each session. Throughout the study, sessions will be audiotaped and 15% of sessions reviewed to assess adherence to protocol. A coding scheme developed a priori will measure the extent to which each session component is implemented by the intervention nurse. Two trained coders will independently rate each session to allow assessment of interrater agreement. Coder disagreement will be resolved via supervised discussion. Any substantial deviations from the prescribed session components will be reported to the Project Manager in the first instance and actioned accordingly. The intervention nurses will be supervised by an investigator who is a qualified psychologist with oversight on treatment fidelity monitoring according to NIH guidelines.
Intervention code [1] 322209 0
Treatment: Other
Comparator / control treatment
Men in the usual care group will receive their standard management that is minimally enhanced with a package of evidence-based resources containing patient education materials about the use of ADT to treat prostate cancer; and advice about referral to support services (approximately 20 minutes of reading material). Resources are readily available from the Prostate Cancer Foundation of Australia.

Participants may peruse at their own discretion but no specific instructions will be given.
Control group
Active

Outcomes
Primary outcome [1] 329577 0
Primary Outcome 1: Quality of Life
This outcome is measured using multiple tools:
- The Functional Assessment of Cancer Therapy – Prostate (FACT-P) assesses men’s disease-specific quality of life across 5 domains: physical, social/family, emotional, functional well-being, and prostate cancer specific concerns.
- The Assessment of Quality of Life (AQoL-8D) instrument is used to derive health utility scores and general health-related QoL among patients. This tool has increased measurement sensitivity to psychosocial elements of health compared to other instruments since it comprises five psychosocial dimensions (mental health, happiness, coping, relationships and self-worth) and three physical dimensions (independent living, pain, and senses).
- The physical function subscale from the Medical Outcomes Study Short-Form-36 (SF-36) questionnaire will be used as an indicator of patient-related physical functioning QoL.
Timepoint [1] 329577 0
Baseline/recruitment (T1) and at 3 months (T2), 6 months (T3) and 12 months (T4) after recruitment.
Primary outcome [2] 329578 0
Primary Outcome 2 : Self-efficacy: The 11-item Cancer Survivorship Self-Efficacy Scale (CS-SES) assesses self-efficacy to manage problems arising from cancer and its treatment specifically.
Timepoint [2] 329578 0
Baseline/recruitment (T1) and at 3 months (T2), 6 months (T3) and 12 months (T4) after recruitment.
Secondary outcome [1] 403090 0
The Brief Symptom Inventory-18 has been replaced with the Generalised Anxiety
Disorder Assessment (GAD-7) and the Patient Health Questionnaire – Depression (PHQ9) as the measures for psychological distress. The GAD-7 and PHQ-9 will be considered independently, each secondary outcome has been separated into a new box.
Timepoint [1] 403090 0
Baseline/recruitment (T1) and at 3 months (T2), 6 months (T3) and 12 months (T4) after recruitment.
Secondary outcome [2] 403091 0
Insomnia: The Insomnia Severity Index (ISI) is the worldwide standard seven item self-report measure that evaluates: (a) severity of sleep-onset, (b) sleep maintenance, (c) early morning awakening problems, (d) satisfaction with current sleep pattern, (e) interference with daily functioning, (f) noticeability of impairment attributed to the sleep problem, and (g) level of distress caused by the sleep problem.
Timepoint [2] 403091 0
Baseline/recruitment (T1) and at 3 months (T2), 6 months (T3) and 12 months (T4) after recruitment.
Secondary outcome [3] 403092 0
Fatigue: The Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) assesses general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigour.
Timepoint [3] 403092 0
Baseline/recruitment (T1) and at 3 months (T2), 6 months (T3) and 12 months (T4) after recruitment.
Secondary outcome [4] 403093 0
Physical activity/exercise: Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) will be used to assess physical activity. Quantitative measures will be derived from the cloud-based exercise platform in which the men can log their exercise and which also incorporates data recording from any activity monitors the men may wear
Timepoint [4] 403093 0
Baseline/recruitment (T1) and at 3 months (T2), 6 months (T3) and 12 months (T4) after recruitment.
Secondary outcome [5] 403961 0
Process Evaluation (acceptability, adoption, appropriateness, penetration, feasibility, fidelity and sustainability). Method of assessment: i) Online survey: Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), & Feasibility of Intervention Measure [1] 1. Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al. Psychometric assessment of three newly developed implementation outcome measures. Implementation Science. 2017;12(1):108; ii) The Working Alliance Inventory - Short Revised (WAI-SR) will assess the therapeutic alliance between participants in the intervention group and nurses delivering the intervention; iii) Semi-structured interviews.
Timepoint [5] 403961 0
i) Across the study period (intervention exposure and adherence measures) ii) Patients: Baseline/recruitment (T1) and at 6 months (T3) after recruitment. iii) Clinical stakeholders: Baseline/recruitment (T1) and at 6 months (T3) after recruitment.
Secondary outcome [6] 403963 0
Cost effectiveness analysis
A cost-utility analysis of the intervention relative to minimally enhanced usual care from a healthcare payer and societal perspectives will be conducted alongside the PCEssentials trial. Costs will be obtained by valuing the health resources used.
Timepoint [6] 403963 0
At baseline, participants will be given a health service use diary to record direct health resources utilised (e.g., GP visits, treatments, and hospitalisations) as well as out-of-pocket expenses and indirect costs (e.g. productivity loss). The diaries will be collected during the baseline, 3, 6 and 12 months surveys.
Quality adjusted life years (QALY) gained will be estimated, weighted by health-related quality of life (i.e. utility score) measured using the AQoL-8D at baseline, 3, 6 and 12 months.
Secondary outcome [7] 415878 0
Psychological distress: The Generalised Anxiety Disorder Assessment (GAD-7) will be used to measure psychological distress. The seven item GAD-7 scale screens for, and assesses the severity of, generalised anxiety disorder in clinical practice and research.
Timepoint [7] 415878 0
Baseline/recruitment (T1) and at 3 months (T2), 6 months (T3) and 12 months (T4) after recruitment.
Secondary outcome [8] 415879 0
Psychological distress: The Patient Health Questionnaire – Depression (PHQ-9) will be used to measure psychological distress. The nine item PHQ-9 scale screens for, and assesses the severity of, depression, and includes a specific item on suicidal ideation.
Timepoint [8] 415879 0
Baseline/recruitment (T1) and at 3 months (T2), 6 months (T3) and 12 months (T4) after recruitment.

Eligibility
Key inclusion criteria
Men who: i) have been diagnosed with prostate cancer and be commencing, or within 3
months of commencement of, ADT, and expected (based on clinical information) to be on
ADT for a minimum continuous time period of 12 months; ii) are able to read and speak
English; iii) are able to give written informed consent; iv) have no previous history of head injury, dementia or psychiatric illness; v) have no other concurrent cancer; and vi) have
phone access.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men with castrate resistant and confirmed metastatic disease will be excluded on the
basis of having progressive and incurable disease that may rapidly progress. No other
disease stage criteria will be applied as the focus of this study is the amelioration of side
effects of androgen deprivation therapy in the short (3 months) and medium-long (12
months post ADT commencement) term.

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)
The randomisation sequence will be undertaken by the project manager and concealed from investigators. Allocation will be through central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur in varying block sizes of four, six and eight (to ensure an unpredictable allocation sequence with equal numbers of men in each treatment group at the completion of each block) with no stratification factors. Random sequence generation will occur using computerised sequence generation.

The randomisation sequence will be undertaken by the project manager and concealed from investigators. Allocation will be through central randomisation by computer.
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
Sample size and statistical power:
Results from recent meta-analyses indicate that individually focussed psychological interventions should produce improvements in psychological distress of at least a medium
effect size (d=0.40) that will be clinically meaningful. To see an effect of this size or greater in our primary outcome, psychological distress at 12 months with 80% power and alpha=0.05, we will require 99 participants in each group to complete the intervention. Assuming 15% attrition, we will recruit 236 patients to the study (118 patients per group).

Statistical methods:
Intervention
The study is a two-arm randomised controlled trial with repeated measures across time and with continuous primary outcome variables.
Recruitment bias will be assessed by comparing sociodemographic and clinical variables
for consenters with non-consenters using t-tests (or Mann-Whitney U tests) for continuous
variables and chi-squared tests for categorical variables.
Possible differential attrition will be assessed by comparing baseline characteristics of drop-outs and continuing participants using t-tests (or Mann-Whitney U tests if appropriate) for continuous variables and chi-squared tests for categorical variables. Outcome Analysis: Intention-to-treat analyses will be conducted. Between-group differences at 3, 6 and 12 months will be analysed by fitting mixed effects regression models. Intervention (Int/usual care) will be included as the main effect. Indicators for participants will be included as a random effect to account for the non-independence of repeated observations from the same individual. Sensitivity analysis will assess the effects of attrition. Mixed effects models with maximum likelihood estimation minimise bias that may arise from ignoring missing observations, and use all available data, thereby maximizing statistical power to detect effects. The mean and 95% confidence interval will be calculated for satisfaction with the intervention. Missing data will be examined for patterns of missingness and addressed with the appropriate multiple imputation methods if required.

Process evaluation
Process evaluation measures will be analysed using a combination of descriptive statistics (measures of program acceptability), and deductive directed content analysis (semi-tructured interviews).

Cost-utility analysis
A cost-utility analysis of the intervention relative to minimally enhanced usual care from a healthcare payer and societal perspectives will be conducted alongside the PCEssentials trial. Costs will be obtained by valuing the health resources used. At baseline, participants will be given a health service use diary to record direct health resources utilised (e.g., GP visits, treatments, and hospitalisations) as well as out-of-pocket expenses and indirect costs (e.g. productivity loss). The diaries will be collected during the baseline, 3, 6 and 12 months surveys. Healthcare resources will be valued using unit prices from standard costing resources such as the Medicare Benefits Schedule and relevant award wages in Australia. Quality adjusted life years (QALY) gained will be estimated, which is a measure of a patient’s life expectancy, weighted by his health-related quality of life (i.e. utility score) measured using the AQoL-8D at baseline, 3, 6 and 12 months. A multivariable generalised linear model will be used to adjust for differences in baseline AQoL-8D scores, demographics and disease classifications. The incremental cost-effectiveness ratio (ICER) will be calculated, which is the difference in mean costs divided by the difference in mean QALYs. Non-parametric bootstrapping will be used to characterise uncertainty around the ICER. If the intervention appears to be cost-effective, we will calculate the expected value of implementation; which is the net monetary benefit of the intervention (i.e., monetary benefits – costs) multiplied by the population of prostate cancer patients expected to benefit from the intervention, adjusted by various patients’ adherence and clinicians’ uptake rates. Uptake rates will be obtained from a formal elicitation exercise and will inform a Bass model to forecast diffusion (i.e., implementation over time).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/11/2022
Actual
7/12/2022
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
236
Accrual to date
71
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310160 0
Government body
Name [1] 310160 0
National Health and Medical Research Council
Country [1] 310160 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
University of Southern Queensland, Centre for Health Research, West Street, Toowoomba, QLD 4350
Country
Australia
Secondary sponsor category [1] 311243 0
None
Name [1] 311243 0
Address [1] 311243 0
Country [1] 311243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309849 0
Metro South Hospital and Health Service - Metro South Human Research Ethics Committee
Ethics committee address [1] 309849 0
Ethics committee country [1] 309849 0
Australia
Date submitted for ethics approval [1] 309849 0
18/11/2021
Approval date [1] 309849 0
20/01/2022
Ethics approval number [1] 309849 0
HREC/2021/QMS/79429

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

Contacts
Principal investigator
Name 115598 0
Prof Jeff Dunn
Address 115598 0
University of Southern Queensland, Centre for Health Research, West Street, Toowoomba, QLD 4350
Country 115598 0
Australia
Phone 115598 0
+61 7 4631 2285
Fax 115598 0
Email 115598 0
[email protected]
Contact person for public queries
Name 115599 0
Anna Green
Address 115599 0
Prostate Cancer Foundation of Australia, Suite 2, Level 8, 1 Chandos Street, St Leonards NSW 2065
Country 115599 0
Australia
Phone 115599 0
+61 2 9438 7060
Fax 115599 0
Email 115599 0
[email protected]
Contact person for scientific queries
Name 115600 0
Anna Green
Address 115600 0
Prostate Cancer Foundation of Australia, Suite 2, Level 8, 1 Chandos Street, St Leonards NSW 2065
Country 115600 0
Australia
Phone 115600 0
+61 2 9438 7060
Fax 115600 0
Email 115600 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data for this trial will not be made available due to: i) ethical restrictions which preclude the sharing of individual participant data; and ii) data containing information that could compromise the privacy of research participants.

Data supporting the findings of this trial will be available through peer-reviewed articles published in relevant journals, and conference presentations.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14115Ethical approval    Ethical approval will be uploaded here when availa... [More Details]



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