Tailored, wEb-based, Psychosocial and Physical Activity Self-Management PrOgramme (TEMPO)

St. Mary's Research Center, Canada

Status: Completed

Conditions: Cancer of Prostate; Anxiety

Treatments: Other: Usual care; Other: TEMPO

Study type: Interventional

Funder types: Other

Identifiers

NCT04304196

MP-CUSM-15-179

Details and patient eligibility

About

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.

Full 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:

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 (i.e., surgery, chemotherapy, radiotherapy, and/or 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups

TEMPO

Experimental group

Description:

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.

Treatment:

Other: TEMPO

Control

Active Comparator group

Description:

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.

Treatment:

Other: Usual care