Sweating caused by prostate cancer androgen deprivation therapy Cancer
Conditions
Interventions
Mancan2 is a mixed method study:
1. A Randomised Controlled Trial (RCT)
2. A Process Evaluation
1. Randomised Controlled Trial:
This study is a phase 3, multi-centre, individually randomised controll
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. A diagnosis of prostate cancer 2. Localised or advanced disease stage. Patients may have had potentially curative treatments including, but not limited to, radiotherapy, brachytherapy or surgery. 3. Currently receiving ADT, and anticipated to require a minimum of 6 months further continuous treatment at the point of registration into the trial. Treatment may have been planned for either a fixed duration (for example, but not limited to, 2 years after radiotherapy) or permanent. Treatment may be with either adjuvant (following potentially curative treatment) or palliative intent. LHRH analogues, LHRH antagonists and surgical castration are all acceptable forms of androgen deprivation. Androgen receptor antagonists, including but not limited to, bicalutamide, enzalutamide, apalutamide or darolutamide, or abiraterone, may be given in combination with androgen deprivation according to local practice. 4. Presence of problematic HFNS symptoms defined as a HFNS Rating Scale score of two or more. 5. Ability to read and understand English without assistance 6. 16 years or older 7. Ability to attend virtual (or face-to-face) group workshops through video conferencing software. If this is not feasible, participants must be able to participate in one-to-one workshops by telephone
Exclusion criteria
Exclusion criteria: 1. Currently with uncontrolled biochemical, radiological or clinical disease progression or relapse if this would be anticipated to interfere with trial participation as determined by the local principal investigator or co-investigator 2. Currently receiving chemotherapy. Prior chemotherapy must have been completed with a minimum of 4 weeks elapsed between the date of the final dose and confirmation of eligibility. Concomitant use of bone health agents, including zoledronate and denosumab is allowed 3. Currently receiving radical multi-fraction external beam radiotherapy or brachytherapy These must have been completed with a minimum of 4 weeks elapsed between the date of the final fraction/treatment and confirmation of eligibility. Single fraction radiotherapy to sites of painful bony metastatic disease or ‘STAMPEDE style’ palliative prostate radiotherapy is allowed 4. Intention to receive ADT on an intermittent schedule 5. Use of experimental drugs within other interventional clinical trials. Co-recruitment to observational studies, or studies of surgery or focal ablation techniques where the interventional component is complete, is acceptable 6. Currently receiving androgen deprivation as a neoadjuvant treatment 7. Medical or psychiatric conditions or other factors that, in the view of the local PI, are likely to impact on the ability of the patient to participate in the trial procedures and interventions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hot flush and night sweat symptoms measured using the HFNS Rating Scale at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hot flush and night sweat symptoms measured using the HFNS Rating Scale at baseline and 6 weeks 2. HFNS frequency measured using a subscale of the HFNS Rating Scale, at 6 weeks and 6 months, compared to baseline 3. HFNS beliefs and behaviours measured using the HFNS Beliefs and Behaviour Scale, at 6 weeks and 6 months, compared to baseline 4. Quality of life measured using the EORTC QLQ-C30 and EORTC QLQ-PR-25, at 6 weeks and 6 months, compared to baseline 5. Anxiety, depression, mood and sleep measured using: 5.1. Generalised Anxiety Disorder Questionnaire (GAD7), at 6 weeks and 6 months, compared to baseline 5.2. Patient Health Questionnaire-9 (PHQ9), at 6 weeks and 6 months, compared to baseline 5.3. Work and Social Adjustment Scale (WSAS), at 6 weeks and 6 months, compared to baseline 5.4. Pittsburgh Sleep Quality Index (PSQI, item 6), at 6 weeks and 6 months, compared to baseline 6. Compliance to ADT measured by percentage of men compliant with the planned duration of ADT at 6 weeks and 6 months 7. Fidelity of CBT measured using: 7.1. Audio recordings of the virtual (pre- and post) intervention group workshops. An independent person will rate a random selection of these for adherence to the treatment manual 7.2. Workshop Attendance logs (completed by CNS) will measure patient compliance to the virtual pre and post group intervention workshops 7.3. Post-intervention questionnaire completed by patients will measure how much of the booklet/CD patients engaged with and what lifestyle changes they have made 8. Resource usage analyses measured using: 8.1. CNS team logs to record staff training cost, time to deliver intervention in a virtual capacity. 8.2. Participant resource use questionnaire 9. Prostate cancer CNS team experiences of delivering this new service measured using interviews with prostate cancer CNS team members 10. Participants’ acceptability of the intervention measured using interviews with participants 11. Barriers and facilitators to implemen | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed