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To Live Better After Prostate Cancer Treatment:

NCT05100121 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Interactive app

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.

OTHER

Supportive Care

During the health dialogues with the nurse, the 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 the patients health record.

Sponsors & Collaborators

Principal Investigators

  • Ann Langius-Eklöf, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2025-06-01
Completion
2025-12-25

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05100121 on ClinicalTrials.gov