Clinical trial NCT05126823: Efficacy of a Combined ACT+ App Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients
Official title: Efficacy of a Combined Acceptance and Commitment Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
Oncology
Acceptation and commitment therapy
Psychological flexibility
Randomized controlled trial
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Mean of Psychological flexibility scores
timeFrame: Change of mean scores of psychological flexibility from baseline to immediately after intervention
Secondary outcomes:
measure: Mean of Anxiety and Depression scores
timeFrame: Change of mean scores of anxiety and depression from baseline to immediately after intervention
measure: Mean of Quality of Life scores using EORTC QLQ C-30
timeFrame: Change of mean scores of the different subscales of quality of life from baseline to immediately after intervention
measure: Mean of Fatigue scores
timeFrame: Change of mean scores of fatigue from baseline to immediately after intervention
measure: Mean of Insomnia scores
timeFrame: Change of mean scores of insomnia from baseline to immediately after intervention
measure: Mean in Post-Traumatic growth scores
timeFrame: Change of mean scores of post-traumatic growth from baseline to immediately after intervention
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
Study officials:
References:
citation: Garcia-Torres F, Gomez-Solis A, Rubio Garcia S, Castillo-Mayen R, Gonzalez Ruiz-Ruano V, Moreno E, Moriana JA, Luque-Salas B, Jaen-Moreno MJ, Cuadrado-Hidalgo F, Galvez-Lara M, Jablonski M, Rodriguez-Alonso B, Aranda E. 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. Front Psychol. 2022 May 18;13:871929. doi: 10.3389/fpsyg.2022.871929. eCollection 2022.