- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04304196
Tailored, wEb-based, Psychosocial and Physical Activity Self-Management PrOgramme (TEMPO)
Reducing Anxiety and Enhancing Quality of Life Among Caregivers of Prostate Cancer Survivors: Development and Evaluation of a Dyadic, Tailored, Web-based, Psychosocial and Physical Activity Self-management Programme
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
BACKGROUND: Despite improvement in survival rates, a prostate cancer diagnosis still elicits negative reactions and confronts both patients and their partners and family caregivers (collectively referred to as 'caregivers') with a wide range of complex physical and psychosocial challenges. However, caregivers' support reduces the demands on the health care system and positively impacts on how well their loved ones adjust to the illness, their support comes at a particularly high cost to their own health and functioning. A recent review found that 16% to 68% of caregivers report needing more support to meet the challenges of their role. Such rates of unmet supportive care needs not only exceed those reported by the patients, but also further contribute to caregivers' burden and adversely impact on patients' quality of life (QOL). In light of caregivers' challenges, the first dyadic, Tailored, wEb-based, psychosocial and physical activity self-Management PrOgramme (called TEMPO) has been developed recently. TEMPO aims to increase patient-caregivers dyads' access to QOL-enhancing support and information, tailored to their needs. Due to the novel nature of this resource, no previous study has evaluated the usefulness of TEMPO.
OBJECTIVES: The goal of this pilot study is to inform the development and planning of a larger trial to evaluate the impact of TEMPO on key outcome measures for patients and caregivers. The primary objective of this pilot study is to (a) explore the feasibility and acceptability of the trial procedures and (b) estimate the cost-effectiveness of this intervention. The secondary objective is to estimate the clinical significance of using TEMPO on the primary and secondary outcomes.
METHODOLOGY: This pilot study is a multicenter, stratified, parallel, two-group RCT. Participating dyads will be randomized to receive (a) TEMPO with usual care or (b) usual care alone. Across participating sites, research assistants (RAs) will screen new patient records and confirm with clinicians whether the patients meet the medical eligibility. The clinician will then obtain interested patients' permission for a RA to approach them and provide further information, including a study brochure. If the potential participant(s) are interested, the RA will take them to a quiet/separate location to further explain the study, check eligibility using the eligibility checklist, and obtain consent. If it is not possible, at a minimum, the RA or hospital volunteer will get potential participants' contact information and their approval for a member of the research team to follow-up. Eligible and interested patients will complete an online consent form. 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.
A convenience sample of patients and their caregivers will be recruited from the , McGill University Health Centre (MUHC), Tom Baker Cancer Centre (TBCC), Vancouver General Hospital (VGH), and Sunnybrook Health Sciences Centre (SHSC).
Patient inclusion criteria are:
- confirmed prostate cancer diagnosis (localized or advanced) within the past two years,
- identified a primary caregiver willing to participate in the study,
- is undergoing or has undergone active treatment (i.e., surgery, chemotherapy, radiotherapy, and/or hormonotherapy),
- 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 who were diagnosed with cancer in the previous year, or who are currently receiving treatment for cancer will be excluded. Patients and caregivers also need to be able to understand English or French.
SIGNIFICANCE: The ability of caregivers to maintain their QOL despite the stressors they face is undermined by limited access to the support needed. This study will evaluate the first dyadic, tailored, web-based, psychosocial and physical activity self-management programme, and address a significant research gap by documenting its acceptability, feasibility. In addition, this study will estimate its potential clinical significance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3T1M5
- St Mary's Hospital Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (patient):
- confirmed prostate cancer diagnosis (localized or advanced) within the past two years,
- identified a primary caregiver willing to participate in the study,
- is undergoing or has undergone active treatment (i.e., surgery, chemotherapy, radiotherapy, and/or hormonotherapy),
- has access to the internet,
- understands English
Exclusion Criteria (patient):
- medical contraindications to participate in moderate physical activity
Inclusion Criteria (caregiver):
- identified as a primary caregiver by an eligible patient willing to participate in the study
- understands English
Exclusion Criteria (caregiver):
- diagnosed with cancer in the previous year
- currently receiving treatment for cancer will be excluded
- medical contraindications to participate in moderate physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TEMPO
These patients and caregivers will be able to access the TEMPO modules and will receive technical support to use it effectively.
Patients will receive usual care throughout the study.
|
TEMPO is designed as a 7- to 10-week, web-based intervention containing 5 modules to pace patient-caregiver dyads' learning, avoid information overload, and allow sufficient practice time in-between modules .
Each module is organized along six key components: needs assessment, tailored information and skills training, goal setting and action planning, motivational and social support, monitoring, automated feedback, and addressing time demands.
Overall, modules aim to a) increase dyads' confidence in using strategies to address key psychosocial issues in the acute survivorship phase (e.g., dealing with stress and worry, communicating with partner and family, uncertainty management) and b) assist dyads in developing the self-regulatory skills necessary to meet the physical activity guidelines.
Each module specifies a series of online (i.e.
didactic material and interactive worksheets) and offline activities (i.e.
practicing the proposed skills).
Other Names:
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Active Comparator: Control
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).
Participants will be given access to the TEMPO website after having completed their final questionnaire, as thanks for participating.
|
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).
Participants will be given access to the TEMPO website after having completed their final questionnaire, as thanks for participating.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Data completion rate
Time Frame: At T2: 13 weeks
|
Investigators will report on rates of missing data from pilot baseline and follow-up questionnaires.
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At T2: 13 weeks
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Consent and follow-up rates
Time Frame: From recruitment launch to completion of follow-up (12 months)
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Number of consenting dyads per week over the recruitment period
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From recruitment launch to completion of follow-up (12 months)
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Fidelity of intervention completion
Time Frame: At T2: 13 weeks
|
Logs will be used to evaluate completion of intervention, as per protocol (e.g., number of log-ins, time spent, modules completed).
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At T2: 13 weeks
|
Rate of tool use
Time Frame: At T2: 13 weeks
|
A 26-item questionnaire was developed by the team to evaluate the tool use.
Each statement is scored using a 7-point likert scale, ranging from "completely disagree" to "completely agree".
The total score is calculated by combining each individual item score.
The total score ranges from 0 to 156.
Higher score means better outcomes.
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At T2: 13 weeks
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Service Usability Scale
Time Frame: At T2: 13 weeks
|
The Service Usability Scale will be used.
The score (1-5 Likert Scale, ranging from "strongly disagree" to "strongly agree") of the 10 statements will be combined into a final note (between 10 and 50).
Higher score means better outcomes.
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At T2: 13 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Sylvie Lambert, PhD, McGill University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-CUSM-15-179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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