None listed
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of a nurse-led survivorship care intervention (PCEssentials), relative to usual care, for improving health-related quality of life in men with prostate cancer undergoing androgen deprivation therapy (ADT). The study will also evaluate whether the intervention is cost-effective, acceptable, appropriate, and feasible compared to usual care. Who is it for? You may be eligible for this study if you are aged 18 years or over, have been diagnosed with prostate cancer, are commencing or within 3 months of commencement of ADT, and are expected to continue ADT for a minimum of 12 months. Study details Participants will be randomised (i.e. allocated by chance) to receive the PCEssentials intervention, or usual care. The PCEssentials intervention will involve five 1-hour psychoeducation sessions delivered via telehealth by a trained prostate cancer specialist nurse. These sessions will occur weekly for four weeks with a booster session at 3 months after recruitment, and will involve one-to-one psychological support, treatment education, tailored strategies to help manage distress, decision making and self-management. Participants in the intervention group will also be provided with a home-based exercise activity program tailored to their need and ability. Participants allocated to usual care 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. All participants will answer a number of questionnaires at the time of recruitment, and at 3, 6, and 12 months after recruitment to assess for changes to quality of life, self-efficacy, psychological distress, sleep, fatigue, and physical activity levels. Interviews will also be conducted to assess for acceptability of the intervention, and a health service use diary will be used to perform cost-effectiveness analysis. It is hoped that this research will demonstrate that the PCEssentials intervention is feasible, acceptable, and effective in improving quality of life, self-efficacy, and sleep, and reducing distress and fatigue in individuals with prostate cancer being treated with ADT.
Interventions
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. D
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.
Sponsors
University of Southern Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed