Prostate cancer intervention study for men with prostate cancer and their partners

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2013
INTERVENTION: This feasibility study will involve men with a diagnosis of prostate cancer and their partner. Couples will either be invited to participate in a self‐management intervention programme over the course of nine weeks, or receive usual care. The overall aim of the study is to develop and evaluate a self‐management psychosocial intervention programme for men with prostate cancer and their partners. There are three stages to the evaluation of the intervention (Donabedian's1978 framework): 1. Evaluating the structure (the resources used in developing and delivering the intervention) 2. Evaluating the process The evaluation will consist of two parts: 2.1. The perceptions and experience of the men and their partners of taking part in the intervention. 2.2. The perceptions and experience of facilitators in delivering the intervention. This will be explored through semi‐ structured interviews with the facilitators. 3. Evaluating the outcome The intervention will be tested by means of a randomised controlled trial. The intervention will be based on a modified version of the FOCUS program (Northouse et al., 2007). The intervention consists of three group meetings (approx. 2 hours per week) on week one, week three and week nine. Men and their partners will also be contacted by telephone on two occasions (week five and week seven). The groups will be facilitated by counsellors from Cancer Focus (formerly the Ulster Cancer Foundation) who will be trained specifically for this purpose. However, while this intervention will be professional led active participation from the patient and their partner will be encouraged. Topics to be covered in the intervention (CONNECT): 1. Couple care: encourage active involvement of men and their partners in a planned programme of care. 2. Optimistic Outlook: assist men and their partners to maintain a positive outlook as they live with the illness and consider their future. 3. Navigating the Journey: assist men and their partners to obtain in CONDITION: Prostate Cancer ; Cancer ; Malignant neoplasm of prostate PRIMARY OUTCOME: To test the feasibility of a self‐management intervention developed for men with prostate cancer and their partners SECONDARY OUTCOME: 1. To investigate the impact of the intervention on the quality of life of men with prostate cancer and their partners; 2. To determine the effectiveness of the intervention programme in improving the self‐efficacy and health behaviours and reducing the uncertainty of men with prostate cancer and their partners; 3. To investigate the ability of the intervention programme to reduce the level of symptom distress reported by individuals with prostate 4. To investigate the impact of the intervention programme on caregiving and communication within the couple; 5. To evaluate the cost of developing and evaluating the intervention; 6. To evaluate the process of the intervention INCLUSION CRITERIA: Men: 1. Over the age of 18 2. Diagnosed with localised adenocarcinoma of the prostate 3. Immediately post surgical / radiation treatment with curative intent, with or without hormonal treatment 4. Physically and mentally (based on consultants assessment) able to participate 5. Provide fully informed written consent 6. Able to communicate in English 7. Have a spouse or cohabiting partner residing in Northern Ireland
Epistemonikos ID: a0150514ca0925ff44ec267b94691f76e4504304
First added on: Aug 25, 2024