Nurse-led Proactive Telephone Follow-up With Patients After Completion of Primary Cancer Treatment

NCT06223022 | Enrolling By Invitation DMC

• 1 other identifier: Department of Nursing
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized study is to test and evaluate nurse-led telephone follow-up intervention in patients primarily curatively treated for breast cancer, colorectal cancer, and prostate cancer. The main question aims to answer: Does this nurse-led telephone follow-up improve patients' quality of life? Participants in both groups will be asked to fill in questionnaires regularly. The intervention group will get a telephone follow-up at predetermined intervals, while the control group will get the care as usual.The investigators will compare intervention and control groups to see if predetermined regular nurse-led telephone follow-up improves quality of life.

Conditions

Breast Cancer; Colorectal Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Patients' reported Quality of life

  Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) The questionnaire consists of 30 items. The QLQ-C30 is composed of both multi-item scales and single-items measures and includes five functional scales, three symptom scales, a global health status /QoL(quality of life) scale, and six single items. Twenty-eight items are answered on a four-point Likert scale with response option labeled "Nor at all", "A little", "Quite a bit" and "Very Much". The last two questions have a seven point scale, ranging from 1 ("Very Poor") to seven ("Excellent"). Higher score for a functional scale represents a high/healthy level of functioning, a high score for the global health status represents a high QoL but a high score for a symptom scale/item represents a high level of symptomatology/problems. The minimum in values is 0, and maximum in values is 100.

  Baseline, 3 months, 6 months and 12 months from inclusion

Secondary Outcomes (6)

• Patients' reported anxiety and depression

  Baseline, 3 months, 6 months and 12 months from inclusion

• Patients' reported quality

  Baseline, 3 months, 6 months and 12 months from inclusion

• Patients' perceptions of illness

  Baseline, 3 months, 6 months and 12 months from inclusion

• Patients' experiences of breast cancer related to body image, sexual functioning, systemic therapy side effects and symptoms

  Baseline, 3 months, 6 months and 12 months from inclusion

• Patients' experiences of colorectal cancer related to symptoms and side effects of treatment and diagnosis.

  Baseline, 3 months, 6 months and 12 months from inclusion

Other Outcomes (2)

• Health-care consumption

  Through study completion, an average of 1 year

• Sick-leave

  Through study completion, an average of 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Receiving regular telephone nurse-led support

Behavioral: Proactive nurse-led telephone follow-up

Control

NO INTERVENTION

Receiving care as usual

Interventions

Proactive nurse-led telephone follow-up BEHAVIORAL

An intervention nurse call the patients regularly with predetermined intervals and give support

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being primarily curatively treated for breast, colorectal-, or prostate cancer

You may not qualify if:

• no adjuvant treatment
• no cognitive impairment
• no known alcohol or other misuse

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Norrlands universitetssjukhus

Umeå, 90187, Sweden

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Senada Hajdarevic, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 25, 2024
• Study Start: January 20, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)