Web-based Intervention for Long-term Breast Cancer Survivors (CUMACA-M)

A Web-based Tailored Intervention to Improve the Quality of Life of Long-term Breast Cancer Survivors. A Randomized Controlled Trial

The number of breast cancer survivors is growing. More cured women are becoming long-term survivors of breast cancer (LS-BC) at least 5 years after diagnosis and after treatment has been completed. Some of these LS-BC return to daily life without any problems; however, in many cases, they experience and have to deal with physical sequelae (chronic fatigue, pain, etc.) psychological sequelae (anxiety, depression, fear of recurrence, etc.) and social sequelae (altered interpersonal relationships, difficulty in returning to work, etc.). For many LS-BC, these health problems are not being met by health professionals. Thus there is a need to promote greater continuity and coordination between specialized oncology care and primary health care in order to enhance specific follow-up of these women in the community. However, the role of the primary health care team in the provision of care in the long-term cancer survival is not clearly defined and few actions have been aimed at improving care activities, standardizing procedures and protocols, developing documentation and registries and updating the training of health care professionals. Therefore, this study aim to design, implement, and evaluate a web based tailored intervention, using artificial intelligence, to improve the quality of life of long-term breast cancer survivors, and self-efficacy for the management of late sequelae from primary care.

Study Overview

• Status: Not yet recruiting
• Conditions: Long-term Effects Secondary to Cancer Therapy in Adults; Long-term Effects of Cancer Treatment
• Intervention / Treatment: Other: CUMACA-M Program

Detailed Description

Hypothesis: A web-based tailored intervention, based on the prevention and management of physical and psychosocial late effects due to cancer treatment and aimed at improving the coexistence of long-term breast cancer, will be more effective in improving quality of life and self-efficacy for the management of late sequelae from Primary Care, than conventional care offered in Primary Care. Aim: To design, implement and evaluate the effectiveness of a web-based tailored intervention, based on artificial intelligence, to improve the quality of life of long-term survivors of breast cancer and self-efficacy for the management of late sequelae from Primary Healthcare. Methodology: Randomized controlled trial (following the Medical Research Council methodological framework). Phase I. Design of a personalized digital intervention based on the results of a review of the available evidence on the needs of long-term survivors (LS-BC) of breast cancer and agreed with a panel of experts. It will be designed in web/mobile application format. The use of algorithms will allow the personalization of the contents according to the needs. Phase II. Piloting: Pre-experimental design pretest-postest with one group, by means of a convenience sampling with LS-BC women, who meet the selection criteria. The collection of sociodemographic and clinical data, as well as the variables under study; quality of life (QOL-BC), self-efficacy in the management of cancer sequelae (Self-Efficacy for Managing Chronic Disease). The participants will use a web application and will test the usability and functionality. Phase III. Implementation of the intervention: Randomized controlled trial. Random sampling of LS-BC and random assignment to the intervention group (CUMACA-M program) or control group (standard care). A protocol will be designed that allows the collection of data and variables (Phase II) and satisfaction with the intervention (CSQ-8), at pre-intervention, and at 3, 6 and 9 months.

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina García-Vivar, PhD; Phone Number: +34948166150; Email: cristina.garciavivar@unavarra.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• having been diagnosed with breast cancer
• having completed active oncological treatments (chemotherapy and/or radiotherapy) in a period of time greater than five years,
• be free of disease at the time of data collection
• be a woman and over 18 years of age
• have knowledge of Internet use.

Exclusion Criteria:

• Women with a diagnosis of cancer other than breast cancer
• Recurrence of cancer or metastasis that causes a new treatment
• Being in active treatment for recurrence or new cancer
• Being a man

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The CUMACA-M Program will focus on a web-based tailored intervention, using artificial intelligence, for Long-Term Survivors of Breast Cancer. It will be structured into modules related to the specific needs of LS-BS, including physical, psychological, and social needs	Other: CUMACA-M Program; The CUMACA-M Program will focus on a web-based tailored intervention, using artificial intelligence, for Long-Term Survivors of Breast Cancer. It will be structured into modules related to the specific needs of LS-BS, including physical, psychological, and social needs
No Intervention: Control group; Usual care in the nursing consultation in primary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life Cancer Survivor (QOL-CS)	The QOL-CS, Spanish version (Ferrell B, Hassey-Dow K, Grant M. Quality of Life Patient/Cancer Survivor Version (QOL-CS) [Internet]. Measurement Instrument Database for the Social Science. 2012). Scale specific for cancer survivor. Likert-type scale with 10 options (1 extremely poor and 10 excellent) with 41 items that measure the four domains of quality of life: physical, psychological, social and spiritual well-being.	Changes from baseline, 3-months, 6 months, and 9 month
Self-Efficacy for Managing Chronic Disease	The Self-Efficacy for Managing Chronic Disease- 6-Item Scale (SEMCD-6) (Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014; 67(11): 1265-73). The scale is structured in 6 items related to symptom control, role performance, emotional state and communication with health professionals	Changes from baseline, 3-months, 6 months, and 9 month
Sociodemographic data of LS-BC	Sociodemographic data of the LS-BC (age, sex, marital status, educational level, employment status) will be collected by means of an ad hoc questionnaire at the beginning of the intervention.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire (CSQ-8)	The satisfaction with the CUMACA-M Program will be measured using the Spanish version of the Client Satisfaction Questionnaire (CSQ-8) (Attkisson CC, Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In Maruish M (Ed). 2004). This scale is structured into 8 items with has five response options (from very dissatisfied to very satisfied).	4 weeks

Collaborators and Investigators

• Sponsor: Cristina García-Vivar
• Collaborators: Instituto de Salud Carlos III

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Survivorship; Cancer survivors; Long-Term Cancer Survivors; Long Term Cancer Survivors
• Other Study ID Numbers: UPNA-CUMACA-B2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No