BACKGROUND : Up to 60% of men with prostate cancer report some level of anxiety, with
clinical levels exceeding population norm. Anxiety results from reactions to the
diagnosis, treatment side effects, and the multitude of other anxiety-provoking physical
and psychosocial challenges (e.g., treatment decision-making) men face daily. These
challenges can be successfully mitigated through self-management, defined as one's
actions and decisions to confidently manage medical aspects of cancer, cope with
emotions, adjust everyday life, and enhance recovery (e.g., via lifestyle changes).
Cancer care lags in the implementation of self-management support, mostly because it
requires clinicians' engagement, which conflicts with their limited availability, even if
self-management is cost-effective. Men then often lack knowledge for effective
self-management; cancer challenges often persist, along with the anxiety they provoke.
Cancer challenges are not self-managed in a vacuum; family caregivers are often relied
on. The impact of caregiving is substantial, but often dismissed, resulting in high
caregiver anxiety. TEMPO, a self-directed, dyadic Tailored, wEb-based psychosocial and
physical activity self-Management PrOgram, was developed because staff shortages
necessitate innovative models to deliver sustainable self-management support, without
compromising efficacy. TEMPO is a tool to help address the quadruple aim of healthcare:
enhance dyads' and clinicians' experiences and improve health outcomes at low cost.
However, in a pilot study, some dyads needed more guidance to use TEMPO. Barriers to use
were mostly motivational, which the investigators previously found can be effectively
addressed by guidance from non-health care professionals to spare clinical resources.
OBJECTIVES : The goal of this study is to determine the most efficacious and
cost-effective way of adapting TEMPO to dyads' needs for guidance. The primary hypotheses
are that a) TEMPO dyads will experience lower anxiety than active monitoring dyads, but
dyads needing guidance will report lower anxiety post guided TEMPO than if they had
continued with TEMPO self-directed; and b) TEMPO will be cost-effective compared to
active monitoring; adding guidance will demonstrate cost-effectiveness among those
needing it. For the secondary hypotheses, same effects are expected of TEMPO and guidance
on the secondary outcomes and between-group differences in anxiety will be higher among
caregivers who are mostly females and women.
METHODOLOGY : This multicenter study is a stratified Sequential Multiple Assignment
Randomized Trial (SMART) across Canada with two sequential intervention stages,
cost-effectiveness analysis, and exit qualitative interviews. Study activities will be
coordinated out of St Mary's Research Centre in Montreal. Using a stepped care approach,
TEMPO will be provided across two intervention stages with variations on timing (initial
vs. delayed) and intensity (self-directed vs. guided). At each centre, clinical
collaborators (physicians, nurses, trial nurse, secretaries etc) may provide brief
information on the study to the target population before, during or after an appointment.
At this time, interested individuals may be given a study pamphlet or be directed to a
displayed poster and the clinical collaborator will obtain permission for a RA to
approach them. Further recruitment strategies may include: direct approaches of patients
by the RA in the waiting room; invitation letters sent to all patients in the target
population matching certain key inclusion criteria without specifically singling out any
individual patients including RA contact information; advertisement of the study on
social media including contact information of the research team; contact by email of
individuals within the target population who have been identified by the investigators
during previous research activities.
Depending on the way interested individuals were identified, the RA will use the content
of the consent form and the study pamphlet to explain the study in detail. All screening
will be done as a structured interview in-person or over the phone where the RA will
complete the eligibility form with patients and their caregivers. The form might be sent
to potential participants directly to complete online. If the caregiver is not present,
the RA will provide study information to the patient and obtain his/her verbal consent to
follow-up by phone within the next week to determine the caregiver's interest in the
study. In addition, each site will display study posters giving potential participants
the ability to self-refer.
Eligible patients and caregivers will be issued a consent form in their preferred format,
depending on the recruitment context. Once the consent form is received, the link to the
online baseline (T0) questionnaire will be emailed. Patient-caregiver dyads returning
their consent forms and baseline questionnaires (T0) will be initially randomized by the
study coordinator to either a) TEMPO self-directed or b) active monitoring of anxiety.
After 12 weeks, TEMPO dyads still reporting anxiety will be re-randomized to more time
with TEMPO or TEMPO plus guidance, and active monitoring dyads will be offered TEMPO. All
participating dyads will continue to access usual care (a co-intervention measure is
included). Group allocation will not be blinded. Dyads will be blinded to hypotheses to
reduce bias. Research assistants (RAs) will not interact with randomized participants
until the exit interview. Guides are not therapists; they focus on adherence, using TEMPO
to answer dyads' questions. Phone calls start with the guide and dyad setting an agenda.
Guides then ask about TEMPO's use since the last call. Guides conclude calls by reviewing
dyad's goals until the next call. Stages 1 and 2 are 12 weeks each. Outcomes are assessed
prior to randomization (baseline, T0) and at completion of Stage 1 (11 weeks
post-randomization, T1) and Stage 2 (22 weeks post-randomization, T2).
SIGNIFICANCE :This proposal builds on the investigators' innovative work on efficient,
evidence-based dyadic self-management interventions that spare clinical resources but
remains efficacious. Clinician partners emphasize the value of TEMPO in their letters of
support. Twice as many centres are participating in this trial, compared to the pilot.
The research team will make cost-effectiveness recommendations with clinical
implementation in mind. Importantly, TEMPO has significant generalizability, as the tools
and approaches can readily be adapted to other cancer populations (see letter from Stuart
Edmond, Canadian Cancer Society). TEMPO is currently being adapted for use among patients
with a head and neck cancer and their caregivers for implementation at the Hospital
Center of the University of Montreal. Several Cancer Agencies are exploring TEMPO's
integration in their resource infrastructure. However, a definitive trial on efficacy,
cost-effectiveness, and adaptation to meet dyad's needs for guidance is needed. The
research team will also contribute to the emerging literature on SMARTs for behavioral
interventions.
