Ignite Creation Date:
2024-05-06 @ 2:24 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04304196
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2020-03-09
Brief Title:
Tailored wEb-based Psychosocial and Physical Activity Self-Management PrOgramme
Sponsor:
St Marys Research Center Canada
Organization:
St Marys Research Center Canada
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEMPO
Brief Summary:
Caregivers of men with prostate cancer report high physical and emotional distress and there is an urgent need to develop cost-effective programmes to prepare them for their roles An online tool has been developed recently aiming to offer a convenient efficient and potentially effective solution However pilot testing is required to evaluate this dyadic Tailored wEb-based psychosocial and physical activity self-Management PrOgramme called TEMPO for caregivers of prostate cancer survivors This study will assess TEMPOs acceptability feasibility cost and potential efficacy in addition to documenting the benefits costs and outcomes gained from involving both the caregiver and the patient in the intervention A total of 80 patient-caregiver dyads will be recruited and randomized to a TEMPO or b usual care Acceptability feasibility and cost indicators will also be collected Quality of life anxiety self-management skills physical activity self-efficacy appraisal and depression will also be assessed at baseline and 3 months post-baseline In addition intervention dyads will be invited to participate in an exit interview This pilot study aims to assess the feasibility of the project to inform the development and planning of a larger trial
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 participants are interested the RA will take them to a quietseparate 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 hisher verbal consent to follow-up by phone within the next week to determine the caregivers 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
1 confirmed prostate cancer diagnosis localized or advanced within the past two years
2 identified a primary caregiver willing to participate in the study
3 is undergoing or has undergone active treatment ie surgery chemotherapy radiotherapy andor hormonotherapy
4 has access to the internet
5 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
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 participants are interested the RA will take them to a quietseparate 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 hisher verbal consent to follow-up by phone within the next week to determine the caregivers 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
1 confirmed prostate cancer diagnosis localized or advanced within the past two years
2 identified a primary caregiver willing to participate in the study
3 is undergoing or has undergone active treatment ie surgery chemotherapy radiotherapy andor hormonotherapy
4 has access to the internet
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None