To Live Better After Prostate Cancer Treatment:

NCT05100121 | Recruiting DMC

• 1 other identifier: Dnr-2019-0037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

mobile health; Prostate cancer; Symptom management; primary care; self- management; Support

Outcome Measures

Primary Outcomes (4)

• Acceptability E -scale

  The Acceptability e-scale is a questionnaire with 6 items that evaluate the acceptability of a system. Items are scored using a Likert scale ranging from 1-5 with higher values indicating higher acceptability.

  6 months

• System Usability Scale (Q5 and Q10)

  The System Usability Scala is a questionnaire with ten item that evaluate the usability of a system. Items are scored using a Likert scale ranging from 1-5. Only question 5 and 10 will be included in this study.

  6 months

• Interviews

  To assess acceptability and feasibility, the participants in the intervention group and the study specific nurses will be interviewed about their experinece using the Interaktor system and about the health dialouges.

  7 months

• Other feasibility measures

  To evaluate the feasibility of the future trial methodology, enrollment, recruitment, and withdrawal rates will be documented. Other feasibility measures include completion rates and missing data in each study questionnaire. Objective measures will be extracted from the logged data in the app, i.e., the number of reports sent (adherence), self-managment advice viewings, and notes from the study-specific nurses.

  Through study completion, an avrage of 24 months

Secondary Outcomes (6)

• Symptom burden measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module

  Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

• Quality of Life measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

  Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

• The Patient Activation Measure (PAM -13)

  Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

• Quality of life measured measured by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)

  Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

• The Sence of Coherence Scale (SOC-13)

  Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months

Study Arms (2)

Intervention

EXPERIMENTAL

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-managment advice in combination with supportive care with a study-specific nurse. At health dialogues with the 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 6 months.

Device: Interactive app; Other: Supportive Care

Control

NO INTERVENTION

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.

Interventions

Interactive app DEVICE

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.

Intervention

Supportive Care OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study is about men with prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Health Care Services Stockholm County (SLSO)

Stockholm, Sweden

RECRUITING

Related Publications (1)

• Langius-Eklof A, Craftman AG, Gellerstedt L, Kelmendi N, Rooth K, Gustavell T, Sundberg K. Digital and nurse-led support intervention in primary care during the first year after curative intent treatment for breast or prostate cancer: study protocol of two cluster randomised controlled pilot trials. BMJ Open. 2025 Feb 22;15(2):e090848. doi: 10.1136/bmjopen-2024-090848.

  PMID: 39986997 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ann Langius-Eklöf, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazmije Kelmendi, PHDstudent

CONTACT

0046-702677869; nazmije.kelmendi@ki.se

Ann Langius-Eklöf, Professor

CONTACT

0046-704315878; ann.langius-eklof@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 29, 2021
• Study Start: October 17, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 25, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)