Anxiety Clinical Trial
Official title:
A SMART Design to Optimize the Delivery of TEMPO - a Tailored, wEb-based Psychosocial and Physical Activity Self-Management PrOgram for Men With Prostate Cancer and Their Caregivers
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.
Status | Not yet recruiting |
Enrollment | 376 |
Est. completion date | August 31, 2028 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Mary's Research Centre | Montreal | Quebec |
Canada | St Mary's Hospital Research Centre | Montréal |
Lead Sponsor | Collaborator |
---|---|
St. Mary's Research Center, Canada | Centre intégré de santé et de services sociaux (CISSS) de Laval, McGill University, Memorial University of Newfoundland, Princess Margaret Hospital, Canada, Simon Fraser University, Sunnybrook Health Sciences Centre, Université de Montréal, Université de Sherbrooke, University of British Columbia, University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HADS-Anxiety | Patients and caregivers will each complete their own self-administered questionnaire at T0-T2 via Qualtrics, a secure electronic data capture system. HADS-Anxiety has strong reliability and validity to assess anxiety symptoms among dyads, including responsiveness. Our previous studies supported its ability to discriminate between anxiety and depression. To avoid testing effect, the HADS-Anxiety score obtained at eligibility screening will be used as baseline, if completed within 2 weeks of baseline, consistent with the HADS' test-retest reliability. In our SMART Coping-Together pilot, most dyads completed eligibility and baseline questionnaires within 1 week. | Baseline, 12 weeks post-baseline and 24 weeks post-baseline | |
Secondary | TEMPO's key mechanisms of action | We will document TEMPO's key mechanisms of action: Primary appraisal = Perceived Stress Scale; secondary appraisal = PROMIS self-efficacy scale and the Multidimensional Self-Efficacy for Exercise Scale; self-management = Health Education Impact Questionnaire and Godin Leisure-Time Exercise Questionnaire (GLTEQ); coping = Dyadic Coping Inventory; depression = HADS-depression, and quality of life = SF-12. All measures were used in our pilot and have demonstrated psychometric properties. For physical activity, the modified GLTEQ is moderately correlated with pedometer and accelerometer derived activity data. Dyads will log weekly their step count in a Participant Steps Diary using the pedometer provided or their own devices. | Baseline, 12 weeks post-baseline and 24 weeks post-baseline |
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