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

Francisco Garcia Torres

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: Acceptance and commitment therapy + app; Behavioral: Acceptance and commitment therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05126823

PY20_00485

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

ACT face-to-face + app

Experimental group

Description:

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

Treatment:

Behavioral: Acceptance and commitment therapy + app

ACT face-to-face

Active Comparator group

Description:

face-to-face ACT sessions

Treatment:

Behavioral: Acceptance and commitment therapy

Waitlist

No Intervention group

Description:

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