Effects of an Interactive ICT-Platform for Assessment and Management of Symptoms in Patients Treated for Prostate Cancer

NCT02477137 | Completed

• 1 other identifier: PhONEME Prostate
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of an interactive ICT-platform for use in a smartphone or tablet in patients treated with radiotherapy for prostate cancer. The hypothesis is that clinical management will be improved and costs reduced and safe and participatory care promoted, when patients report symptoms in an application which provides self-care advice and instant access to professionals.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Nursing; Health Literacy; Quality of Life; Radiotherapy; Oncology Nursing; Self Care; Symptom Management; Participatory Care; Person-centered Care; Information and Communication Technology; Patient-reported symptoms; Mobile device

Outcome Measures

Primary Outcomes (6)

• Questionnaire Scale for Functional Health Literacy (S-FHL - Swedish version)

  To evaluate self-reported data in terms of understanding and communicating health

  up to 3 months after completion of radiotherapy treatment

• Questionnaire Individualized Care Scale (ICS)

  To evaluate self-reported data in terms of individualized care as measured by the ICS

  up to 3 months after completion of radiotherapy treatment

• Questionnaire Sense of Coherence Scale (KASAM)

  To evaluate self-reported data in terms of Sense of Coherence

  up to 3 months after completion of radiotherapy treatment

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)

  To evaluate self-reported data in terms of health related quality of life

  up to 3 months after completion of radiotherapy treatment

• EORTC Prostate-specific module (QLQ-PR25) Questionnaire

  To evaluate self-reported data in terms of symptom prevalence, characteristics and distress related to prostate cancer

  up to 3 months after completion of radiotherapy treatment

• Scale for Communicative and Critical Health Literacy (S-C & C HL - Swedish version)

  To evaluate self-reported data in terms of health literacy

  up to 3 months after completion of radiotherapy treatment

Secondary Outcomes (1)

• Health care costs

  up to 3 months after completion of radiotherapy treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

In combination with usual care according to the routines at the clinic, patients in the intervention group are given access to an application for a smartphone/tablet for daily reporting of symptoms, access to self-care advice and health-care professionals in real time.

Device: smartphone or tablet

Control group

NO INTERVENTION

Usual care according to the routines at the clinic.

Interventions

smartphone or tablet DEVICE

Patients in the intervention group are given access to an application for a smartphone/tablet for daily reporting of symptoms, access to self-care advice and health-care professionals in real time.

Also known as: Intervention

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of prostate cancer without metastases or spread to the lymph nodes,
• will receive radiation therapy for at least five (5) weeks,
• literacy in the Swedish language

You may not qualify if:

• Patients who need an interpreter at the doctor's visit
• Patients who have a known severe cognitive impairment

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (2)

• Crafoord MT, Ekstrand J, Sundberg K, Nilsson MI, Fjell M, Langius-Eklof A. Mobile Electronic Patient-Reported Outcomes and Interactive Support During Breast and Prostate Cancer Treatment: Health Economic Evaluation From Two Randomized Controlled Trials. JMIR Cancer. 2025 Mar 11;11:e53539. doi: 10.2196/53539.

  PMID: 40067346 DERIVED

• Langius-Eklof A, Crafoord MT, Christiansen M, Fjell M, Sundberg K. Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer. BMC Cancer. 2017 Jul 4;17(1):466. doi: 10.1186/s12885-017-3450-y.

  PMID: 28676102 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Methods

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)

Investigative Techniques

Study Officials

• Ann Langius-Eklöf, RN, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 22, 2015
• Study Start: July 20, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 7, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

SE (1)