Psychosocial eHealth in Advanced Lung Cancer

NCT05497973 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2023-09-29

No results posted yet for this study

Summary

Being diagnosed with cancer impairs many areas of a person's life. Although efficacious educational, emotional and social interventions exist in this regard, they often reach few survivors and late. This project, carried out by a specialized centre in cancer care and health research, will study the effectiveness, costs, and utility associated with a digital ecosystem tailored to meet the needs of patients with advanced lung cancer. This solution bridges the gap between patients and professionals to offer health services precisely when they are needed. The project is developed in the first year of an advanced lung cancer diagnosis, comparing the effects of the digital ecosystem with usual care in terms of their capacity to improve various psychosocial indicators. A comparative economic analysis will be carried out as well, to prove the cost-utility of the digital ecosystem presented.

Conditions

  • Lung Cancer, Nonsmall Cell, Stage IIIA
  • Lung Cancer Non-Small Cell Stage IIIB
  • Lung Cancer Non-Small Cell Stage III
  • Lung Cancer Stage IV
  • Lung Cancer

Interventions

BEHAVIORAL

E-health ecosystem of stepped psychosocial care

1. Screening and monitoring: weekly administration of an emotional state thermometer. If the score is \>5, participants are asked to complete the HADS. If HADS' score \>10, step 2 is assigned. The same procedure is followed for steps 3 \& 4. Participants remain in each step for 2 weeks, and all level changes are preceded by a videoconference with a health professional 2. Online psychoeducation campus: displays co-constructed videos and posts developed by health professionals and patients about LC diagnosis and treatment aspects. 3. Online support community: anonymous survivors with LC diagnoses are included. Professionals and patient mentors supervise and foster debate, peer support, and resolve health Q\&As. 4. Weekly online group psychotherapy led by a clinical psychologist and composed of eight 90-minute sessions. Eligible users are placed on a waiting list, starting when 5-6 users are available.

BEHAVIORAL

Usual psychosocial care

Usual psychosocial care for cancer survivors at ICOHospitalet centre led by a clinical psychologist. Usual psychosocial care consists of 7 individual sessions of 45-60 minutes, with 2-3 weeks of space between sessions, based on Individual Meaning-Centered Psychotherapy (IMCP) for Patients With Advanced Cancer (Breitbart et al., 2012). Moreover, they will be offered the education materials from the 2nd step of the platform, as they are compiled on a website open to all patients and relatives.

Sponsors & Collaborators

  • Asociación Española contra el Cáncer

    collaborator OTHER
  • Institut d'Investigació Biomèdica de Bellvitge

    collaborator OTHER
  • Institut Català d'Oncologia

    lead OTHER

Principal Investigators

  • Cristian Ochoa, PhD · Institut Català d'Oncologia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT05497973 on ClinicalTrials.gov