NCT05126823

Efficacy of a Combined ACT+ App Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients

Recruiting now NA Last updated 28 March 2025

What this trial tests

NA trial testing Acceptance and commitment therapy + app in Cancer in 120 participants. Currently enrolling.

Timeline

1 February 2022

Primary endpoint
1 June 2024

31 December 2025

Quick facts

Lead sponsor	Francisco Garcia Torres
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	120
Start date	1 February 2022
Primary completion	1 June 2024
Estimated completion	31 December 2025
Sites	1 location across Spain

Drugs / interventions tested

• Acceptance and commitment therapy + app
• Acceptance and commitment therapy

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Francisco Garcia Torres

Who can join

Adults 18 to 65, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: emotional and physical alterations frequently appear in cancer patients. In this sense, interventions based on acceptance and commitment therapy (ACT) show their efficacy to improve these symptoms through increased psychological flexibility, however, there is little evidence of the efficacy of ACT using combined modality (face-to-face + app), despite the fact that this application modality may have beneficial effects in this group of patients, who may see their participation in the interventions limited as a consequence of the disease.

Method / design: Cancer patients will be randomly assigned to one of the following groups: (1) face-to-face ACT + app group, (2) face-to-face ACT group, and (3) group receiving usual treatment. The planned interventions last between 8 and 10 weeks and include experiential exercises, metaphors, discussions, and homework assignments to promote awareness and flexibility about thoughts and emotions associated with cancer. In the group that uses the app, exercises (mindfulness, breathing), reminder systems, recording, reinforcement and monitoring will also be provided. It is estimated that a total of 112 participants (38 per group) will be necessary, and four evaluations will be carried out: T0 (pre-treatment), T1 (post-treatment, T2 (follow-up at three months) and T3 (follow-up at six months). months).

Hypothesis : The primary results that are expected to be obtained are a significant increase in the psychological flexibility of patients receiving treatment, with greater flexibility in the group receiving the combined intervention, evaluated with the AAQ-II. Furthermore, as secondary outcomes, it is expected to obtain significant improvements in anxiety and depression (HADS), quality of life (EORTC QLQ C-30), Fatigue (BFI), Insomnia (ISI) and post-traumatic growth (PTGI-SF).

Hypothesis: the efficacy of the ACT-based intervention in cancer patients may be increased if the benefits of using a modality that combines face-to-face and not face-to-face are added to it.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of a Combined Acceptance and Commitment Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients: Study Protocol for a Randomized Controlled Trial.
   García-Torres F, Gómez-Solís Á, Rubio García S, Castillo-Mayén R, et al · · 2022 · cited 4× · PMID 35664159 · DOI 10.3389/fpsyg.2022.871929
2. Anxiety, depression, quality of life and the mediating role of psychological flexibility: A study on Spanish cancer patients.
   García-Torres F, García-Carmona M, Gómez-Solís Á, Jurado-González F, et al · · 2025 · PMID 40595087 · DOI 10.1038/s41598-025-06942-6