A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Mary's Research Center, Canada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
TEMPO
BehavioralStage 1 interventions (weeks 1-12): TEMPO. After 12 weeks, the benefit of the initial assignment will be assessed. Benefit is defined as a score \< 3 on the ESAS-r anxiety item (range 0-10) or a decrease \>= 2 points from eligibility screening. If both dyad members had anxiety symptoms at recruitment, both must meet the benefit criterion. If one member no longer meets the criterion, the dyad is considered "did not benefit." Stage 2 interventions (weeks 13-25): TEMPO or lay guidance. 1. TEMPO responders will continue with TEMPO. Dyads who did not benefit will be re-randomized to: 1. Stepping up to lay guidance (8 x 20-minute calls via phone or Teams). Guides will receive TEMPO training and conduct semi-structured exit interviews. 2. More time with TEMPO for dyads who benefited from it. 2. Non-responders to usual care in Stage 1 will be stepped up to TEMPO.
Active Monitoring dyads' anxiety
Other interventionStage 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 13-25): 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.
Treatment groups
376 Participants
are divided into 2 treatment groupsGroup A: TEMPOExperimental treatment 1 intervention
Group B: Actively Monitoring dyads' anxietyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety
The primary outcome is anxiety to compare TEMPO vs. usual care at 13 weeks and within the TEMPO group, the impact of re-randomizing those who do not benefit from TEMPO to 1a) TEMPO + lay guidance vs. 1b) continue with TEMPO at 25 weeks. The primary measure will be the 7-item Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale, which was used in the research teams' pilot and has strong and validity to assess anxiety symptoms among dyads, including responsiveness. A psychometric review of anxiety and depression questionnaires used with patients with cancer identified the HADS as one of the questionnaires with the strongest psychometric properties. The scale range is 0-21. Subscale scores of 0-7 are categorized as normal, subscale scores of 8 to 10 are categorized as borderline and scores of 11 to 21 as clinical anxiety.
Time frame
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baselineSecondary outcomes
1
Perceived Stress Scale (PSS)
10 items that measure the degree participants appraise situations in their life as stressful. Each question rated on a 5-point Likert scale, and a summary score obtained by summing all 10 items. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress, scores ranging from 14-26 would be considered moderate stress, and scores ranging from 27-40 would be considered high perceived stress.
Time frame
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline2
Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy Scale
4 items measuring self-efficacy to manage difficult situations and find solutions. Raw scores range from 4-20. Higher scores indicate higher perceived general self-efficacy, lower scores indicate lower perceived general self-efficacy.
Time frame
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline3
Health Education Impact Questionnaire (heiQ)
The Health Education Impact Questionnaire (heiQ) includes eight independent dimensions to measure self-management strategies. Given the aim of TEMPO six of the eight dimensions will be given: (a) positive and active engagement in life, (b) skill and technique acquisition, (c) constructive attitude and approaches, (d) self-monitoring and insight, (e) health services navigation, and (f) social integration and support.
Time frame
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline4
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Participants are asked to indicate: "How many times per week on average did you do the following kinds of exercise over the past month?" The following kinds of exercise include: mild, moderate and strenuous.
Time frame
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Mary's Research Center, Canada
Lead sponsor
Princess Margaret Hospital, Canada
Collaborator
University of Calgary
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
University of British Columbia
Collaborator
McGill University
Collaborator
Simon Fraser University
Collaborator
Université de Sherbrooke
Collaborator
Memorial University of Newfoundland
Collaborator
Université de Montréal
Collaborator
CISSS de Laval
Collaborator
Source ClinicalTrials.gov