Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03017456
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2017-01-04
Brief Title:
PC 360 Survivorship
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Prostate Cancer Survivorship 360
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prostate Cancer Survivorship 360ยบ is a collaboration-based initiative involving prostate cancer PC and survivorship researchersclinicians from three Canadian prostate centers with the goal of identifying and tracking unmet supportive care needs of patients with localized PC and responding to these needs through survivorship care The current randomized control trail RCT will focus on the development and evaluation of a facilitated electronic Prostate Cancer Survivorship Care Plan PC-SCP The aims of this project are 1 to develop an appropriate and tailored SCP and transition care delivery process and 2 to conduct an RCT to evaluate whether a personalized PC SCP intervention is more effective than usual care UC on patient activation primary outcome and access to services self-Management support satisfaction with information HRQoL and cancer worry secondary outcomes Data from a multi-site prospective database- Prostate Cancer Survivorship Information System PC360-IS will be used to electronically populate the survivorship care plans Overall this proposal represents initial steps in uniting the country in sharing programmatic resources data expertise and enthusiasm to transform survivorship care for men with PC and their families
Detailed Description:
A Phase III RCT will evaluate the superiority of a Survivorship Care Plan SCP intervention SCP-Int compared with usual care UC after primary curative prostate cancer PC treatment Each of the three sites has designated clinical study leads AM LG and ST high referral volumes and study leads patients will be entered into the PC360-IS database which will be interfaced to the PC-SCP system to consolidate patient details and generate personalized SCPs Research ethics approval will be obtained at each site The trial will be registered with clinicaltrialsgov and reported using the CONSORT recommendations for trials
The study population inclusion criteria are as follows Histologically confirmed localized T1-T3N0M0 PC age at diagnosis 18 years treated with curative intent treatment received 1 month and 6 months disease-free as defined by absence of somatic disease activity parameters as per oncologisturologist consented to participate in the PC360-IS database Exclusion Criteria Patients who do not receive treatment and are followed by active surveillance inability to complete study questionnaires
Eligible patients will be randomly assigned to either the intervention arm or the control arm A biostatistician will randomly assign participants to ensure that both the study RA and the participants are unaware of the treatment SCP-intcontrol groups UC Consenting patients will be registered into the study and randomized to receive either the SCP-Int or UC Patients in the SCP-Int arm will be scheduled for the SCP-Int appointment on the same day as the patients first or second follow-up appointment
Eligible patients will be sent a study information letter which will be signed by the patients urologist oncologist one month after the end of primary treatment The RA will then contact patients to further explain the study If agreeable the patients will be sent consent forms two stamped envelopes and a baseline questionnaire to complete prior to the scheduled follow-up appointment The patients will be asked to mail back the signed consent form and the completed questionnaire in each the envelopes provided
Participants will have as much time as needed to decide if the participants would like to participate in the study prior to signing the consent form The Research Analyst will obtain consent
Planned trial interventions SCP-Int Patients in the SCP-Int arm will be asked to attend a one-time appointment with a trained oncology nurse study nurse To avoid additional travel and related costs to the patient this appointment will be scheduled on the same day as the patients follow-up appointment The SCP-Int is comprised of two components a 30-minute nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP PC-SCP The intervention will be developed based on an established person-centred nursing framework with a tailored approach to customizing the intervention to the individual and will focus on the provision of self-management education and support and promote access to and coordination of post-treatment care including appropriate referrals to relevant programs and services including TrueNTH solutions The content of the PC-SCP will provide structure to the appointment Persistent effects and concerns that are identified will prompt the development of a tailored management plan ie patient education referral to programs and services captured within the PC-SCP Relevant patient education and TrueNTH materials will be linked electronically The appointment will focus on empowering the PC survivor to actively self-manage persistent treatment effects and to decrease the patients risk of late effects by providing effective health information support and self-management support Nurses will integrate a number of active behaviour change ingredients including the integration of motivational interviewing techniques which are effective in increasing healthy behaviours Usual Care UC Patients in the UC arm will receive care according to usual practice This usually involves a brief office visit approximately 5-10 minutes with pertinent history and physical examination related to surgicalradiation recovery review of the pathology and general instructions regarding the next step in follow-up In addition patients in the UC arm will be able to access any supportive care programs or service available at the hospital according to usual practice Currently SCPs and dedicated transition appointments are not provided as part of a standard of care
Allocation to trial groups Patients will be allocated to either SCP-Int or UC by the Department of Biostatistics at Princess Margaret using a computer-generated randomization process random blocks known only to statisticians The research coordinator will telephone Biostatistics staff who will not be involved in recruitment to obtain the subjects assignment Eligible patients from each site will be approached until the target number of participants is reached or until a decision is made to stop recruitment
Data collection Data will be collected and analyzed according to the outlined project aims Based on CONSORT criteria a screening log will enable data collection on eligible and non-recruited patients with reasons for non-recruitment recorded when known All data will be entered into a secured password protected database within the UHN server A separate database will be used for participant tracking to prevent re-approaching patients unnecessarily and to ensure patients are receiving the questionnaire packages according to the study timeline
Proposed primary and secondary outcome measures
The outcome measures were chosen based on recent consensus and recommendations on the evaluation of SCPs Patients will be assessed at baseline T0 6 T1 and 12 T2 months post-treatment This questionnaire package is estimated to take 45 minutes to complete
Primary Outcome Patient activation will be measured using the Patient Activation Measure PAM-13 a 13-items measure assessing knowledge skills beliefs and confidence in managing health and health care Patient activation is strongly related to a broad range of health-related outcomes The primary outcome will be the overall score of the 13 items collected at T2
Secondary Outcomes a Supportive care services utilization using the Health and Social Services Utilization Inventory HSSUI modified for use in cancer populations Service types are grouped into five categories Health Professionals InstitutionalHospital Programs Nursing and Homemaker Support Programs Other Community and Social Support ProgramResources will include True NTH solutions ProgramsResources b Self-Management Support will be assessed using the Health Education Impact Questionnaire heiQ designed to evaluate outcomes from patient education and self-management interventions for people with chronic conditions c Satisfaction with Information will be measured with the 25-item European Organisation for Research and Treatment of Cancer Quality of Life INFO25 module which evaluates satisfaction with information received by cancer patients d Quality of Life will be measured using the Expanded Prostate Cancer Index Composite EPIC which assesses PC-specific quality of life and e Cancer Worry will be measured using the Assessment of Survivors Concerns ASC measure which assesses fear of recurrence and health in cancer survivors
Proposed sample size and justification Our sample size calculations are based on 85 power with an alpha-level of 005 a standard deviation of 16 and a difference between groups of 8 points on the primary outcome or half a standard deviation difference Given these specifications the required sample size is 146 patients or 73 patients per arm Assuming attrition of up to 20 180 patients will be recruited or 90 patients per arm Based on previous studies we expect to enroll about 70 of eligible patients The number of potentially eligible patients from participating sites is estimated to vary between 15-30 patients per month Based on these estimates and our anticipated participation rates we anticipate recruiting 20 patients per month with total recruitment completed within 9 months We anticipate at least 80 will complete the 12-month post-treatment follow-up We will use multiple strategies to promote retention and prevent attrition Reasons for participant attrition will be documented
Proposed analyses Analyses will be performed adhering to the intention to treat principle Descriptive statistics will be used to summarize baseline demographic and clinical characteristics of participants in both groups Recruitment bias and possible differential attrition will be assessed by calculating the standardized differences between the two arms The overall PAM-13 score at 12 months adjusted for the baseline score will be compared between the two arms using the t-test if the data appears normal or the Mann-Whitney test otherwise A p-value005 will be deemed significant Secondary analyses of all scores at each time point will be conducted utilizing the mixed effect modeling to account for the intra-patient and intra-centre dependency due to the repeated measures within a patient and the multi-centre design The residuals will be inspected and data will be transformed when necessary Due to multiple testing for the secondary analyses a Hochberg-Benjamini approach will be used to ensure that the type I error rate does not exceed 005
Cost-utility analyses The analysis will also include a trial-based cost utility analysis The health utility measured using the PORPUS-U and EQ-5D instruments will be used to provide patient-specific and group-mean estimates of quality-adjusted survival Quality Adjusted Life Years Costs from the payer perspective and from the societal perspective will be gathered using the HSSUI and an estimate of intervention costs Inverse probability weighting will be used to adjust for induced dependent censoring A net benefit regression approach will be employed to explore predictors of cost-effectiveness
The study population inclusion criteria are as follows Histologically confirmed localized T1-T3N0M0 PC age at diagnosis 18 years treated with curative intent treatment received 1 month and 6 months disease-free as defined by absence of somatic disease activity parameters as per oncologisturologist consented to participate in the PC360-IS database Exclusion Criteria Patients who do not receive treatment and are followed by active surveillance inability to complete study questionnaires
Eligible patients will be randomly assigned to either the intervention arm or the control arm A biostatistician will randomly assign participants to ensure that both the study RA and the participants are unaware of the treatment SCP-intcontrol groups UC Consenting patients will be registered into the study and randomized to receive either the SCP-Int or UC Patients in the SCP-Int arm will be scheduled for the SCP-Int appointment on the same day as the patients first or second follow-up appointment
Eligible patients will be sent a study information letter which will be signed by the patients urologist oncologist one month after the end of primary treatment The RA will then contact patients to further explain the study If agreeable the patients will be sent consent forms two stamped envelopes and a baseline questionnaire to complete prior to the scheduled follow-up appointment The patients will be asked to mail back the signed consent form and the completed questionnaire in each the envelopes provided
Participants will have as much time as needed to decide if the participants would like to participate in the study prior to signing the consent form The Research Analyst will obtain consent
Planned trial interventions SCP-Int Patients in the SCP-Int arm will be asked to attend a one-time appointment with a trained oncology nurse study nurse To avoid additional travel and related costs to the patient this appointment will be scheduled on the same day as the patients follow-up appointment The SCP-Int is comprised of two components a 30-minute nurse-led face-to-face intervention and the provision of a tailored PC-specific SCP PC-SCP The intervention will be developed based on an established person-centred nursing framework with a tailored approach to customizing the intervention to the individual and will focus on the provision of self-management education and support and promote access to and coordination of post-treatment care including appropriate referrals to relevant programs and services including TrueNTH solutions The content of the PC-SCP will provide structure to the appointment Persistent effects and concerns that are identified will prompt the development of a tailored management plan ie patient education referral to programs and services captured within the PC-SCP Relevant patient education and TrueNTH materials will be linked electronically The appointment will focus on empowering the PC survivor to actively self-manage persistent treatment effects and to decrease the patients risk of late effects by providing effective health information support and self-management support Nurses will integrate a number of active behaviour change ingredients including the integration of motivational interviewing techniques which are effective in increasing healthy behaviours Usual Care UC Patients in the UC arm will receive care according to usual practice This usually involves a brief office visit approximately 5-10 minutes with pertinent history and physical examination related to surgicalradiation recovery review of the pathology and general instructions regarding the next step in follow-up In addition patients in the UC arm will be able to access any supportive care programs or service available at the hospital according to usual practice Currently SCPs and dedicated transition appointments are not provided as part of a standard of care
Allocation to trial groups Patients will be allocated to either SCP-Int or UC by the Department of Biostatistics at Princess Margaret using a computer-generated randomization process random blocks known only to statisticians The research coordinator will telephone Biostatistics staff who will not be involved in recruitment to obtain the subjects assignment Eligible patients from each site will be approached until the target number of participants is reached or until a decision is made to stop recruitment
Data collection Data will be collected and analyzed according to the outlined project aims Based on CONSORT criteria a screening log will enable data collection on eligible and non-recruited patients with reasons for non-recruitment recorded when known All data will be entered into a secured password protected database within the UHN server A separate database will be used for participant tracking to prevent re-approaching patients unnecessarily and to ensure patients are receiving the questionnaire packages according to the study timeline
Proposed primary and secondary outcome measures
The outcome measures were chosen based on recent consensus and recommendations on the evaluation of SCPs Patients will be assessed at baseline T0 6 T1 and 12 T2 months post-treatment This questionnaire package is estimated to take 45 minutes to complete
Primary Outcome Patient activation will be measured using the Patient Activation Measure PAM-13 a 13-items measure assessing knowledge skills beliefs and confidence in managing health and health care Patient activation is strongly related to a broad range of health-related outcomes The primary outcome will be the overall score of the 13 items collected at T2
Secondary Outcomes a Supportive care services utilization using the Health and Social Services Utilization Inventory HSSUI modified for use in cancer populations Service types are grouped into five categories Health Professionals InstitutionalHospital Programs Nursing and Homemaker Support Programs Other Community and Social Support ProgramResources will include True NTH solutions ProgramsResources b Self-Management Support will be assessed using the Health Education Impact Questionnaire heiQ designed to evaluate outcomes from patient education and self-management interventions for people with chronic conditions c Satisfaction with Information will be measured with the 25-item European Organisation for Research and Treatment of Cancer Quality of Life INFO25 module which evaluates satisfaction with information received by cancer patients d Quality of Life will be measured using the Expanded Prostate Cancer Index Composite EPIC which assesses PC-specific quality of life and e Cancer Worry will be measured using the Assessment of Survivors Concerns ASC measure which assesses fear of recurrence and health in cancer survivors
Proposed sample size and justification Our sample size calculations are based on 85 power with an alpha-level of 005 a standard deviation of 16 and a difference between groups of 8 points on the primary outcome or half a standard deviation difference Given these specifications the required sample size is 146 patients or 73 patients per arm Assuming attrition of up to 20 180 patients will be recruited or 90 patients per arm Based on previous studies we expect to enroll about 70 of eligible patients The number of potentially eligible patients from participating sites is estimated to vary between 15-30 patients per month Based on these estimates and our anticipated participation rates we anticipate recruiting 20 patients per month with total recruitment completed within 9 months We anticipate at least 80 will complete the 12-month post-treatment follow-up We will use multiple strategies to promote retention and prevent attrition Reasons for participant attrition will be documented
Proposed analyses Analyses will be performed adhering to the intention to treat principle Descriptive statistics will be used to summarize baseline demographic and clinical characteristics of participants in both groups Recruitment bias and possible differential attrition will be assessed by calculating the standardized differences between the two arms The overall PAM-13 score at 12 months adjusted for the baseline score will be compared between the two arms using the t-test if the data appears normal or the Mann-Whitney test otherwise A p-value005 will be deemed significant Secondary analyses of all scores at each time point will be conducted utilizing the mixed effect modeling to account for the intra-patient and intra-centre dependency due to the repeated measures within a patient and the multi-centre design The residuals will be inspected and data will be transformed when necessary Due to multiple testing for the secondary analyses a Hochberg-Benjamini approach will be used to ensure that the type I error rate does not exceed 005
Cost-utility analyses The analysis will also include a trial-based cost utility analysis The health utility measured using the PORPUS-U and EQ-5D instruments will be used to provide patient-specific and group-mean estimates of quality-adjusted survival Quality Adjusted Life Years Costs from the payer perspective and from the societal perspective will be gathered using the HSSUI and an estimate of intervention costs Inverse probability weighting will be used to adjust for induced dependent censoring A net benefit regression approach will be employed to explore predictors of cost-effectiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None