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

Study Overview
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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.

Official Title
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Efficacy of a Combined Acceptance and Commitment Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients: a Randomized Controlled Clinical Trial

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Acceptance and commitment therapy + app
* Behavioral: Acceptance and commitment therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACT face-to-face + app<br>Combines face-to-face ACT sessions with non-face-to-face activities and resources (mobile applications) | Behavioral: Acceptance and commitment therapy + app<br>* 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<br>|
| Active Comparator: ACT face-to-face<br>face-to-face ACT sessions | Behavioral: Acceptance and commitment therapy<br>* 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<br>|
| No Intervention: Waitlist<br>Waitlist group. After the second assessment of the two ACT groups (at post-treatment) this group will receive the face to face ACT intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of Anxiety and Depression scores | Hospital Anxiety and Depression Scale (HADS). This scale is used to assess anxiety and depression in a hospital settings. It is made up of 14 items (7 for anxiety and 7 for depression), which are answered on a scale from 0 to 3, with maximum values of 21 in each of the subscales | 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 | EORTC QLQ C-30 (version 3), this is an instrument developed to assess the quality of life in cancer patients using 30 questions that refer to the quality of life experienced by the patient during the last week. The first twenty-eight items include questions about different symptoms and are answered on a scale that ranges from 1 (not at all) to 4 (a lot), while the last two ask patients about the perception of their global health and quality of life in a scale from 1 (terrible) to 7 (excellent). The different items are grouped into functional scales (physical / role / emotional / cognitive / social and global) and symptom scale (fatigue / nausea and vomiting / dyspnea / sleep problems / loss of appetite / constipation / diarrhea and financial impact ). | Change of mean scores of the different subscales of quality of life from baseline to immediately after intervention | 
| Mean of Fatigue scores | Brief Fatigue Inventory (BFI), is an instrument developed to assess fatigue in cancer patients that consists of 10 items with a Likert-type scale that assesses fatigue experienced in the last 24 hours from 0 (no fatigue) to 10 (worst fatigue imaginable). It also includes a scale to assess the degree to which fatigue has interfered with the patient's daily life in the last 24 hours, with a scale ranging from 0 (does not interfere) to 10 (completely inferred). The recommended cut-off points in cancer patients are: 1-3 (mild); 4-7 (moderate) and 8-10 (severe) | Change of mean scores of fatigue from baseline to immediately after intervention | 
| Mean of Insomnia scores | Insomnia Severity Index (ISI). This instrument is designed to assess the severity of insomnia experienced through 5 items that are scored on a scale from 0 (not at all) to 4 (very severe / very dissatisfied / very much). The sum of the scores given by the subject to the different items are added together and a total score is obtained that ranges from 0-28. The recommended cut-off points are as follows: 0-7 (absence of clinical insomnia), 8-14 (subclinical insomnia), 15-21 (moderate clinical insomnia), and 22-28 (severe clinical insomnia). | Change of mean scores of insomnia from baseline to immediately after intervention | 
| Mean in Post-Traumatic growth scores | Post-traumatic Growth Inventory-short version (PTGI-SF), is an instrument designed to evaluate the positive change that people who are subjected to a traumatic event may experience, using 10 items that respond to a Likert-type scale from 0 (no I have experienced that change) to 5 (I have experienced that change to a great extent), with higher scores showing greater positive change | Change of mean scores of post-traumatic growth from baseline to immediately after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Oncology, Acceptation and commitment therapy, Psychological flexibility, Randomized controlled trial