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

Abstract

Psychological flexibility is a key concept of acceptation and commitment therapy (ACT). This factor has been linked with psychological wellbeing and associated factors, such as quality of life, in cancer patients. These and other positive results of acceptation and commitment therapy in cancer patients found in previous research could be enhanced by using mhealth tools. A three-arm randomized superiority clinical trial, with a pre-post-follow-up repeated measures intergroup design with a 1:1:1 allocation ratio is proposed. A hundred and twenty cancer patients will be randomly assigned to one of the following interventions: (1) face-to-face ACT + mobile application (app), (2) face-to-face ACT, and (3) Waitlist control group. The primary expected outcome is to observe significant improvements in psychological flexibility acceptance and action questionnaire- II (AAQ-II) in the face-to-face ACT + app group, after comparing baseline and post-treatment scores, and the scores will remain stable in the two assessment points, 3 and 6 months after the intervention. Secondary expected outcomes are significant increasing scores in quality of life (EORTC QLQ C-30) and post-traumatic-growth (PTGI-SF), and significant decreasing scores in anxiety and depression (HADS), insomnia (ISI) and fatigue (BFI) at the same assessment points. Also, it is expected that the scores of this group will be higher than the scores of the face-to-face ACT group and the waitlist control group. This study aims to assess the efficacy of a combined intervention (face-to face ACT + app) for psychological flexibility and associated symptoms in cancer patients. The results of this protocol may help to consider the use of acceptation and commitment therapy and mhealth applications in cancer settings as a valid therapeutic choice.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT05126823].

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“…Secondary outcome measures using questionnaires will be analyzed following the Intention to Treat (ITT). ANOVA or chi-square will be used to compare the sociodemographic data and baseline outcome measures (T0) [ 50 ]. Secondly, longitudinal changes (baseline, post-treatment, and 1 month and 3 months follow-up) and the differences between the two groups will be examined using mixed linear models as these models are more precise than the repeated measures of ANOVA [ 50 ].…”

“…ANOVA or chi-square will be used to compare the sociodemographic data and baseline outcome measures (T0) [ 50 ]. Secondly, longitudinal changes (baseline, post-treatment, and 1 month and 3 months follow-up) and the differences between the two groups will be examined using mixed linear models as these models are more precise than the repeated measures of ANOVA [ 50 ]. Missing or incomplete data will be considered in the ITT analysis using maximum likelihood estimation method [ 50 ].…”

“…Secondly, longitudinal changes (baseline, post-treatment, and 1 month and 3 months follow-up) and the differences between the two groups will be examined using mixed linear models as these models are more precise than the repeated measures of ANOVA [ 50 ]. Missing or incomplete data will be considered in the ITT analysis using maximum likelihood estimation method [ 50 ]. Effect sizes will be calculated using Cohen’s d (bias corrected) to represent the difference between Standard Mean Changes (MC) (T0-T2, T0-T3, T0-T4) [ 50 ].…”

“…Missing or incomplete data will be considered in the ITT analysis using maximum likelihood estimation method [ 50 ]. Effect sizes will be calculated using Cohen’s d (bias corrected) to represent the difference between Standard Mean Changes (MC) (T0-T2, T0-T3, T0-T4) [ 50 ]. Calculation of SMC in each group will be conducted, providing the d index of the general effect size from the differences between combined Individualized Management Plan (IMP) and Professional Problem-Solving Peer (PPSP) debrief vs. informal peer debrief [ 50 ].…”

“…Effect sizes will be calculated using Cohen’s d (bias corrected) to represent the difference between Standard Mean Changes (MC) (T0-T2, T0-T3, T0-T4) [ 50 ]. Calculation of SMC in each group will be conducted, providing the d index of the general effect size from the differences between combined Individualized Management Plan (IMP) and Professional Problem-Solving Peer (PPSP) debrief vs. informal peer debrief [ 50 ]. After the data is analyzed, summary tables will be provided for all planned evaluations at pre-treatment (T0), post-treatment (T2), 1 month follow-up (T3), and 3 months follow-up (T4) [ 50 ].…”