Improving psychological flexibility in cancer patients using an app and therapy
Efficacy of a Combined Acceptance and Commitment Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients: a Randomized Controlled Clinical Trial
This study is testing whether a combination of therapy and a mobile app can help cancer patients feel more flexible in their thinking and better manage their emotions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universidad de Córdoba Academic / other |
| Locations | 1 site (Córdoba) |
| Trial ID | NCT05126823 on ClinicalTrials.gov |
What this trial studies
This intervention aims to enhance psychological flexibility and alleviate associated symptoms in cancer patients through a combined approach of acceptance and commitment therapy (ACT) delivered both face-to-face and via a mobile app. Participants will be randomly assigned to one of three groups: a combined ACT + app group, a face-to-face ACT group, or a usual treatment group. The interventions will last between 8 and 10 weeks and will include experiential exercises, discussions, and homework assignments designed to foster awareness and flexibility regarding thoughts and emotions related to cancer.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 70 with a cancer diagnosis (stages I-III) who are currently receiving treatment and can communicate in Spanish.
Not a fit: Patients over 70 years old, those with stage IV cancer, or individuals currently receiving other psychological treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental well-being and coping strategies of cancer patients.
How similar studies have performed: While ACT has shown efficacy in improving psychological outcomes in cancer patients, the specific combined modality of face-to-face and app-based intervention is relatively novel and has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria for participants are: * Men and women, aged between 18 and 70 years. * Cancer diagnosis, stages I-III. * Cancer type: Breast / Lung / Colorectal. * Eligible for or currently receiving cancer treatment. * Ability to be fluent in Spanish. * Have a smartphone with daily access and basic smartphone / application management skills. * Access to email account and internet. * Not currently participating in another clinical trial. * Not currently receiving other psychological treatment. Exclusion criteria for participants in the trial: * Men and women aged\> 70 years. * Diagnosis of cancer, stage IV or other types of cancer. * Not eligible for treatment. * Inability to handle himself fluently in Spanish. * Not having a smartphone with daily access and basic smartphone / application skills. * Not having access to an email account and the internet. * Currently participating in another clinical trial. * Currently receiving other psychological treatment.
Where this trial is running
Córdoba
- Hospital Universitario Reina Sofía — Córdoba, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.