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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ACT face-to-face + app

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

Group Type EXPERIMENTAL

Acceptance and commitment therapy + app

Intervention Type 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

face-to-face ACT sessions

Group Type ACTIVE_COMPARATOR

Acceptance and commitment therapy

Intervention Type 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

Waitlist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acceptance and commitment therapy + app

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

Intervention Type BEHAVIORAL

Acceptance and commitment therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No