Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03017456 |
| Other study ID # |
15-5045-CE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 29, 2017 |
| Est. completion date |
January 31, 2020 |
Study information
| Verified date |
May 2023 |
| Source |
University Health Network, Toronto |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Prostate Cancer Survivorship 360º is a collaboration-based initiative involving prostate
cancer (PC) and survivorship researchers/clinicians 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.
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 clinicaltrials.gov 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 oncologist/urologist; 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-int)/control 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 patient's first (or second) follow-up appointment.
Eligible patients will be sent a study information letter which will be signed by the
patient's 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
patient's 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 (i.e. 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 surgical/radiation 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 subject's
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, Institutional/Hospital Programs;
Nursing and Homemaker Support Programs; Other Community and Social Support Program/Resources
(will include True NTH solutions); Programs/Resources.; 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 0.05, 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-value<=0.05 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 0.05.
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.
