Online Psychosocial Cancer Screening, Monitoring and Stepped Treatment in Cancer Survivors
NCT04372459 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184
Last updated 2024-03-06
Summary
This multicenter randomized controlled study will appraise the effectiveness and cost-utility of an e-health ecosystem with integrated and stepped psychosocial services that will be compared with the usual psychosocial care. The study is developed in the acute survival phase among breast cancer survivors. The outcomes of both interventions will be compared in terms of the amount of waiting time to receive psychosocial care and changes in several psychosocial variables. Finally, a comparative economic analysis will be conducted in other relevant psychosocial and health parameters. The e-health platform is expected to outperform usual care in the aforementioned indicators, while reaching high acceptability and usability by survivors, and additionally reducing costs for health providers.
Conditions
- Breast Cancer
- Psychological Distress
- Emotional Disorder
Interventions
- BEHAVIORAL
-
Online integrated and stepped psychosocial care
This program features four levels of care, increasing in intensity of psychosocial care as patients move from one level to the next one. Step 1: Screening and monitoring of several psychosocial variables through the central mobile application of the program (App ICOnnecta't). Step 2: Online guided and self-help psychoeducation Campus in which patients can consult videos and online resources, co-constructed between health professionals and patients, containing reliable and rigorous information related to the oncological process. Step 3: Online community of psychosocial support. Participants can choose from 12 cancer-related discussion forums and share with the community any health-related question that worries them fostering, thus, debate and stimulating peer-support. Step 4: Intensive online group psychotherapy (App ICOnnecta't Videoconsultation), based on the Group Positive Psychotherapy program for cancer survivors (Ochoa, Sumalla, Maté, Castejón, Rodríguez et al., 2010).
- BEHAVIORAL
-
Usual psychosocial care
This active control group will receive the standard psychosocial treatment for cancer survivors in the participating centers, led by a clinical psychologist and consisting of 8 individual, 45/60-minute sessions, each of which every 1-2 months, focused on providing emotional support and psychoeducation during the first year of primary cancer treatment.
Sponsors & Collaborators
-
Institut Català d'Oncologia
lead OTHER
Principal Investigators
-
Cristian Ochoa, PhD · Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-21
- Primary Completion
- 2023-07-30
- Completion
- 2023-07-30
Countries
- Spain
Study Locations
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