To Live Better and Longer With Prostate Cancer:

Study Overview
=================
Brief Summary
-----------------
It is evident that patients receiving treatment for cancer have symptoms that often are undetected. Furthermore, many survivors from cancer have ongoing poor health and well-being and long-term rehabilitation and support should not be neglected to prevent recurrence and increase survival. There are good reasons to believe that routine collection of relevant patient-reported symptoms facilitates a person-centered care where the patient is a participatory member in the team. This study aims to evaluate the effects of routine assessment of diagnose-related symptoms assisted with an app during the first year of survivor ship in patients with prostate cancer in combination with survivor ship care coached by a district nurse, in primary health care and compare it to standard care only. The hypothesis is improved symptom burden and improved quality of life.

Detailed Description
-----------------
Prostate cancer is the most common form of cancer in Sweden and the most common form of cancer among men in Sweden, representing approximately 30 percent of all cancer cases among men. The median age for being diagnosed with prostate cancer is around 69. The treatments available for prostate cancer can impact the patients' quality of life (QoL) (Katz, 2007). After surgery and radiation treatment, the function of the bowel and bladder is affected. Erectile dysfunction is common after surgery, radiation, and hormonal therapy. Symptoms and side effects can start quite suddenly, get improved, but also persist a long time after treatment. Psychosocial support to patients during the treatment shows different results, some with positive effects on QoL by psychoeducational or nurse-delivered interventions and some with no effect at all. Patient-reported outcome (PRO) is an outcome that is reported by the patients. Previous research on collecting PROs through an interactive application during treatment for breast cancer, pancreatic cancer, and prostate cancer shows promising results such as reduced symptom burden and improved QoL as well as on survival. A synthesis of current research on web-based interventions shows how important it is that content is specific to the patients' needs and delivered at the right stage in the cancer trajectory and emphasize user involvement in the developmental phase. The aim is to evaluate the effects of routine assessment of patient reported symptoms and support in self-management assisted with mobile technology (an app) during the first year of survivorship in patients with breast- and prostate cancer in combination with survivorship care coached by a study-specific nurse. The primary hypotheses are improved symptom burden and quality of life improvement. Secondary hypotheses are that the intervention is cost-effective and increase survival. This study will be performed in primary health care within the Stockholm County Council, Sweden. There are around 200 Primary Health Care Centers (PHCC) in Stockholm. Cluster randomization of the PHCC will be used. To achieve representative PHCCs for randomization a Care Need Index (CNI) is used. CNI is a model that measures healthcare needs for the distribution of primary care resources to the population with the biggest need. Based on CNI and population number four PHCC units with high CNI index (low socioeconomic status) and four PHCC with low CNI index (high socioeconomic status) will be selected. A matched pair randomization stratified design will be used which is often preferable when randomizing numbers of clusters. In total 70 patients will receive the intervention and standard care and 70 patients in a control group receiving standard care.

Official Title
-----------------
To Live Better and Longer With Prostate Cancer: Effects of Supportive and Person-centered Care Assisted by Mobile Technology

Conditions
-----------------
Prostate Cancer, Survivorship

Intervention / Treatment
-----------------
* Device: Interactive app
* Other: Survivor-ship care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with prostate cancer at the end of curative treatment able to read and understand Swedish considered being physically, psychologically and cognitively able to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention consists of standard care and an app for routine symptom reporting, weekly the first month and thereafter as mutually agreed, at minimum once a month in one year, with instant self-care advice in combination with supportive care with a district nurse. At coaching sessions with the district nurse, the patient-reported assessments in the app will be used to discuss the individual's current situation and to plan eventual additional actions needed. The intervention will last for 12 months. | Device: Interactive app<br>* In the app, the patients will report frequency and distress on commons concerns regarding urine dysfunction, bowel dysfunction, emotional distress, sleep, pain, loss of appetite, hot flashes/sweating, edema, and sexual dysfunction. Free text comments will also be possible to make to cover the patients' other potential needs. Questions regarding symptoms of acute character that might need to be treated quickly like severe pain, blood in stool and urine, and involuntary weight loss will also be asked for to timely detect and treat signs of for example cancer relapse. Information about the concerns will be included in the app containing; a) general information of why they have the side effect and what it means b) evidence-based advice about self-management; c) when they should contact health care providers, and d) further information linked to reliable documents and web pages.<br>Other: Survivor-ship care<br>* At coaching session with the district nurse, patient reported assessments will be used to discuss the individual's current situation and to plan eventual additional actions needed such as support from a physiotherapist, social worker, dietitian or if a visit to the physician if needed. This is documented in a survivorship care plan which contain e.g., risk of symptoms, late effects, healthy lifestyle information, prevention tips and support of psychosocial concerns. The intervention incorporates coaching encounters using motivational interviewing techniques to engage patients in the patient-owned survivor-ship care plan that include health goals and strategies related to cancer follow-up, surveillance, symptom management, and health behavior.<br>|
| No Intervention: Control<br>The participants in the control group will only receive standard care. Usually after ended curative treatment the follow-up is a blood sample (PSA) every three or six months the first year, this can be handled either by a nurse or a physician in secondary care. Most hospitals also have one physical meeting with a physician three months after ended treatment (Regional Cancer Centers, 2020). All patients are allocated a contact nurse with a telephone number to contact when needed. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module | The questionnaire has 25 items and evaluates specific prostate cancer symptoms related to treatment such as sexual function and bladder and bowel problem. Items are scored using a Likert scale ranging from 1-4 with higher values indicating more burden of symptoms and divided in six sub-scales. | The patients answer the questionnaire at baseline and 6 months, 12 months, 18 months, and 24 months later. | 
| Quality of Life measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire | The questionnaire has 30 items divided in five functional scales (physical, role, emotional, social, and cognitive), eight symptom scales (fatigue, nausea and vomiting, pain, insomnia, appetite loss, constipation, diarrhea), financial impact of the disease, and a global health status/QoL scale. Questions are scored using a Likert scale ranging from 1-4 with higher values indicating lower QoL. | The patients answer the questionnaire at baseline and 6 months, 12 months, 18 months, and 24 months later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life measured measured by the EuroQol 5-Dimension Questionnaire (EQ-5D) | For this study used together with direct costs to analyse Quality of adjusted life years by weighting life expectancy of a patient against estimation of a persons' health related Quality of Life score. | From baseline to 24 month post treatment | 
| Survival | Data from registers | From baseline to 10 years post treatment | 
| Direct costs collected in a specific Stockholm based register | The register contains data on patients consumption of health care in Stockholm. For this study visits to health care and days of hospitalization are collected. | From baseline to 24 month post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mobile health, Prostate cancer, Survivorship care, Quality of life, Symptom management