Clinical trial · Interventional
Tailored, wEb-based, Psychosocial and Physical Activity Self-Management PrOgramme
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TEMPO | Other | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TEMPO
- 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.
- interventionNames
- Other: TEMPO
- type
- ACTIVE_COMPARATOR
- label
- Control
- 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.
- interventionNames
- Other: Usual care
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLambert SD, Duncan LR, Ellis J, Robinson JW, Sears C, Culos-Reed N, Matthew A, De Raad M, Schaffler JL, Mina DS, Saha-Chaudhuri P, McTaggart-Cowan H, Peacock S. A study protocol for a multicenter randomized pilot trial of a dyadic, tailored, web-based, psychosocial, and physical activity self-management program (TEMPO) for men with prostate cancer and their caregivers. Pilot Feasibility Stud. 2021 Mar 20;7(1):78. doi: 10.1186/s40814-021-00791-6. PMID 33743804