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

NCT05126823 | Active Not Recruiting DMC

• 1 other identifier: PY20_00485
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Oncology; Acceptation and commitment therapy; Psychological flexibility; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Mean of Psychological flexibility scores

  Acceptance and Action Questionnaire- II (AAQ-II). This instrument is designed to assess experiential avoidance and psychological inflexibility through 7 items that are answered with a Likert-type scale from 1 (never true) to 7 (always true) and a higher score indicates greater experiential avoidance (Bond et al., 2011).

  Change of mean scores of psychological flexibility from baseline to immediately after intervention

Secondary Outcomes (5)

• Mean of Anxiety and Depression scores

  Change of mean scores of anxiety and depression from baseline to immediately after intervention

• Mean of Quality of Life scores using EORTC QLQ C-30

  Change of mean scores of the different subscales of quality of life from baseline to immediately after intervention

• Mean of Fatigue scores

  Change of mean scores of fatigue from baseline to immediately after intervention

• Mean of Insomnia scores

  Change of mean scores of insomnia from baseline to immediately after intervention

• Mean in Post-Traumatic growth scores

  Change of mean scores of post-traumatic growth from baseline to immediately after intervention

Study Arms (3)

ACT face-to-face + app

EXPERIMENTAL

Combines face-to-face ACT sessions with non-face-to-face activities and resources (mobile applications)

Behavioral: Acceptance and commitment therapy + app

ACT face-to-face

ACTIVE COMPARATOR

face-to-face ACT sessions

Behavioral: Acceptance and commitment therapy

Waitlist

NO INTERVENTION

Waitlist group. After the second assessment of the two ACT groups (at post-treatment) this group will receive the face to face ACT intervention.

Interventions

Acceptance and commitment therapy BEHAVIORAL

In the group ACT, experiential exercises are carried out, metaphors, discussions and assignments are used to promote awareness and flexibility about the thoughts and emotions associated with cancer

ACT face-to-face

Acceptance and commitment therapy + app BEHAVIORAL

In the group ACT+app, experiential exercises are carried out, metaphors, discussions and assignments are used to promote awareness and flexibility about the thoughts and emotions associated with cancer and interleaved non-contact activities, which will serve as support for each of the modules. The non-contact activities will consist of assigning tasks, practices (mindfulness, breathing), reminder systems, recording, reinforcement and monitoring. Resources such as short texts, videos, audio files and recording systems will be used

ACT face-to-face + app

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Garcia Torres: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14005, Spain

Location

Related Publications (2)

• Garcia-Torres F, Garcia-Carmona M, Gomez-Solis A, Jurado-Gonzalez F, Jablonski M, Jaen-Moreno MJ, Aranda E. Anxiety, depression, quality of life and the mediating role of psychological flexibility: A study on Spanish cancer patients. Sci Rep. 2025 Jul 2;15(1):22530. doi: 10.1038/s41598-025-06942-6.

  PMID: 40595087 DERIVED

• 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.

  PMID: 35664159 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Amyloid; Acceptance and Commitment Therapy

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 19, 2021
• Study Start: February 1, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)