Trial Title:
A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
NCT ID:
NCT06363266
Condition:
Cancer of the Prostate
Anxiety
Conditions: Official terms:
Prostatic Neoplasms
TEMPO
Conditions: Keywords:
Behavior Change
Caregivers
Coping
E-Health
Illness Self-Management
Physical Activity
Psychosocial Oncology
Self-Directed Interventions
Web-Based Interventions
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
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). All
dyads will continue to access usual care (a co-intervention measure is included).
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
TEMPO
Description:
Stage 1 interventions (week 1-12): After 12 weeks, response will be determined. At
recruitment, at least one member of the dyad must report anxiety symptoms defined as a
Hospital Anxiety and Depression Scale (HADS)-Anxiety subscale score > 6. After Stage 1,
for the dyad to be "TEMPO Responder", both members' anxiety scores on the HADS-Anxiety
must be < 6 or decreased by at least 2 points. If both members of the dyad had anxiety
symptoms at recruitment, then both must meet a response criterion. As soon as one dyad
member does not meet the response criterion, the dyad is "TEMPO non-responder".
Stage 2 interventions (week 14-25): TEMPO responders continue with TEMPO. Non-responders
will be re-randomized to: a) more time with TEMPO or b) add non-health care professional
guidance (8 x 20-minute telephone calls). Guides' training will include TEMPO review,
their role and the manual. Semi-structured exit interview will gather guides'
experiences.
Arm group label:
TEMPO
Other name:
Tailored, wEb-based, Psychosocial and Physical Activity Self- Management PrOgramme
Intervention type:
Other
Intervention name:
Active Monitoring dyads' anxiety
Description:
Stage 1 interventions (week 1-12): Patients will receive usual care throughout the study.
Dyads in this group will not receive any information resources from the research team but
will have access to all of those available at their participating center (sites will be
asked to provide a description of usual care practices).
Stage 2 interventions (week 14-25): Dyads not responding to active monitoring will be
stepped up to TEMPO; responders to active monitoring will only be invited to complete the
follow-up measures.
Arm group label:
Actively Monitoring dyads' anxiety
Summary:
Men with prostate cancer and their family caregivers face many physical and emotional
challenges from the cancer itself and its treatment(s), which often lead to high anxiety.
The pandemic has highlighted the importance of protecting our physical and mental health,
and the complex responsibilities that caregivers have in supporting their loved ones. To
improve the health of men with prostate cancer and of their caregivers, the research team
developed TEMPO: a self-directed Tailored, wEb-based, psychosocial and physical activity
self-Management PrOgram. TEMPO was developed with men with prostate cancer and their
caregivers over the past 8 years. It also combines the investigators' research conducted
over the past decade on providing the best support to those affected by cancer. Because
the cancer care workforce is already overstretched, the research team designed TEMPO to
be used without guidance from a health care professional. TEMPO is one-of-a kind in its
support of both patients and caregivers, and the integration of coping skills training on
a wide range of cancer challenges along with a home-based exercise program. Patients and
caregivers who have used TEMPO said they improved their communication, learned new skills
to cope with both physical and emotional challenges of cancer, and increased their
physical activity. The present project builds on this work to further evaluate the cost
and impact of TEMPO on men's and caregivers' health. Men with prostate cancer and their
caregivers will be assigned by chance to one of two groups a) TEMPO or b) monitor their
anxiety for 12 weeks. After 12 weeks, patients' and caregivers' needing more support will
be identified based on an assessment of their anxiety level. For those already using
TEMPO and needing more support, non-health care professional guidance might be offered.
All those in the monitoring group needing more support will now have access to TEMPO. All
participants complete surveys to determine whether TEMPO led to improved health outcomes.
Detailed description:
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 study is a Sequential Multiple Assignment Randomized Trial (SMART)
with two sequential intervention stages, cost-effectiveness analysis, and exit
qualitative interviews. 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). Dyads will initially be randomized to 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).
Patient inclusion criteria are:
- Received treatment for prostate cancer (excluding active surveillance) within the
past two years
- Identified a primary caregiver willing to participate in the study
- One member of the dyad has anxiety symptoms
- Has access to the internet,
- Understands English or French. Eligible caregivers will be those identified by the
patient as his primary source of support. Caregivers also need to be able to read
English or French.
Dyads exclusion criteria are:
- Either member of the dyad is hospitalized at recruitment
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 Centre
Hospitalier de l'Université de Montréal. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- treatment for prostate cancer (excluding active surveillance) received within the
past 2 years
- participate with a self-identified caregiver
- one member of the dyad has anxiety symptoms
- Patients and caregivers need to be able to read English or French
- internet access
Exclusion Criteria:
- either member of the dyad is hospitalized at recruitment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Mary's Research Centre
Address:
City:
Montreal
Zip:
H3T1M5
Country:
Canada
Contact:
Last name:
Sylvie Lambert, PhD
Phone:
514-398-3685
Email:
sylvie.lambert@mcgill.ca
Facility:
Name:
St Mary's Hospital Research Centre
Address:
City:
Montréal
Country:
Canada
Contact:
Last name:
Manon de Raad
Email:
manon.deraad@ssss.gouv.qc.ca
Start date:
September 1, 2024
Completion date:
August 31, 2028
Lead sponsor:
Agency:
St. Mary's Research Center, Canada
Agency class:
Other
Collaborator:
Agency:
Princess Margaret Hospital, Canada
Agency class:
Other
Collaborator:
Agency:
University of Calgary
Agency class:
Other
Collaborator:
Agency:
Sunnybrook Health Sciences Centre
Agency class:
Other
Collaborator:
Agency:
University of British Columbia
Agency class:
Other
Collaborator:
Agency:
McGill University
Agency class:
Other
Collaborator:
Agency:
Simon Fraser University
Agency class:
Other
Collaborator:
Agency:
Université de Sherbrooke
Agency class:
Other
Collaborator:
Agency:
Memorial University of Newfoundland
Agency class:
Other
Collaborator:
Agency:
Université de Montréal
Agency class:
Other
Collaborator:
Agency:
Centre intégré de santé et de services sociaux (CISSS) de Laval
Agency class:
Other
Source:
St. Mary's Research Center, Canada
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06363266
