Clinical trial NCT05100121: To Live Better After Prostate Cancer Treatment:
Official title: To Live Better After Prostate Cancer Treatment: a Randomized Pilot Trial of Supportive and Person-centered Care Intervention in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: mobile health
Prostate cancer
Symptom management
primary care
self- management
Support
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 person-centered care where the patient is a participatory member of the team. This study aims to pilot-test a supportive intervention in primary care for six months during the first year after primary treatment for prostate cancer in primary care and compare it to standard care only. The intervention consists of symptom reporting and self-management in an app in combination with health dialogues with a study-specific nurse at a primary care centre.

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\&amp;amp;#39; needs and delivered at the right stage in the cancer trajectory and emphasize user involvement in the developmental phase.

The aim is to pilot-test routine assessment of patient reported symptoms and support in self-management assisted by digital technology for six months during the first year after primary treatment for prostate cancer in combination with helath dialouges with a study-specific nurse at the primary care centre.

The primary objective is to evaluate the acceptability and feasibility of digital and nurse-led support intervention in primary care during the first after primary treatment. The secondary objectives of these trials are to (i) evaluate the potential efficacy of the intervention and (ii) obtain estimates for secondary outcome measures and potential mediators and moderators to be used in a future trial and (iii) evaluate the feasibility of such assessments.

There are around 250 Primary Health Care Centers (PHCC) in Stockholm and 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. High CNI index equals low socioeconomic status and low CNI index equals high socioeconomic status. The study has a prospective, cluster randomized controlled pilot trial design The studies have two parallel arms; the intervention plus standard care (intervention group); and standard care alone (control group). Approximately ten PHCCs will be matched on CNI index and the number of patients allocated to the PHCCs.

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

Primary outcomes:
measure: Acceptability E -scale
timeFrame: 6 months
measure: System Usability Scale (Q5 and Q10)
timeFrame: 6 months
measure: Interviews
timeFrame: 7 months
measure: Other feasibility measures
timeFrame: Through study completion, an avrage of 24 months
Secondary outcomes:
measure: Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
measure: Quality of Life measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
measure: The Patient Activation Measure (PAM -13)
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
measure: Quality of life measured measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
measure: The Sence of Coherence Scale (SOC-13)
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
measure: Health Literacy CCHL (5-items)
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Health Care Services Stockholm County (SLSO)
Study officials:
affiliation: Karolinska Institutet
name: Ann Langius-Eklöf, Professor
role: PRINCIPAL_INVESTIGATOR
References: