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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Data completion rate
研究概览
简要总结
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 TEMPO's 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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Data completion rate
时间窗: At T2: 13 weeks
Investigators will report on rates of missing data from pilot baseline and follow-up questionnaires.
Fidelity of intervention completion
时间窗: 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).
Rate of tool use
时间窗: 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.
Consent and follow-up rates
时间窗: From recruitment launch to completion of follow-up (12 months)
Number of consenting dyads per week over the recruitment period
Service Usability Scale
时间窗: 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.
次要结局
未报告次要终点
研究者
Sylvie Lambert
Principal Scientist
St. Mary's Research Center, Canada