CancerNCT05126823
Efficacy of a Combined ACT+ App Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients
A study testing Acceptance and commitment therapy + app and Acceptance and commitment therapy in people with Cancer, run by Francisco Garcia Torres at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer
- What is being tested?
- Acceptance and commitment therapy + app and Acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Combined Acceptance and Commitment Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients: a Randomized Controlled Clinical Trial
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).
Read more
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
- Being tested
- Acceptance and commitment therapy + app, Acceptance and commitment therapy
- Keywords
- Cancer, Oncology, Acceptation and commitment therapy, Psychological flexibility, Randomized controlled trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapy + appBehavioural
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
Acceptance and commitment therapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| ACT face-to-face + app | Experimental | Combines face-to-face ACT sessions with non-face-to-face activities and resources (mobile applications) Receives: Behavioral: Acceptance and commitment therapy + app |
| ACT face-to-face | Active comparator | face-to-face ACT sessions Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change of mean scores of psychological flexibility from baseline to immediately after intervention
Secondary outcomes (5)
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
Measured: 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 ).
Measured: 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)
Measured: 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).
Measured: 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
Measured: Change of mean scores of post-traumatic growth from baseline to immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Feb 2022
- Primary completion1 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Garcia Torres
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Garcia Torres, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126823
- Sponsor's protocol ID
- PY20_00485
- Status last verified
- Apr 2026
- First submitted
- 27 Oct 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not applicable for this essay
Publications
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.
PubMed 40595087Garcia-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.
PubMed 35664159
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Combined Acceptance and Commitment Intervention to Improve Psychological Flexibility and Associated Symptoms in Cancer Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05126823
- Acronym / sponsor ID
- PY20_00485
- Conditions
- Cancer
- Keywords
- Cancer, Oncology, Acceptation and commitment therapy, Psychological flexibility, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Francisco Garcia TorresUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.
| Arm | Type | Receives |
|---|---|---|
| ACT face-to-face + app | Experimental | Behavioral: Acceptance and commitment therapy + appCombines face-to-face ACT sessions with non-face-to-face activities and resources (mobile applications) |
| ACT face-to-face | Active comparator | Behavioral: Acceptance and commitment therapyface-to-face ACT sessions |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and commitment therapy + appIn 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 | Behavioural | ACT face-to-face + app |
| Acceptance and commitment therapyIn 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 | Behavioural | ACT face-to-face |
Primary outcome
Mean of Psychological flexibility scores
Time frame: Change of mean scores of psychological flexibility from baseline to immediately after intervention
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).
5 secondary outcomes
Mean of Anxiety and Depression scores
Time frame: 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
Time frame: Change of mean scores of the different subscales of quality of life from baseline to immediately after intervention
Mean of Fatigue scores
Time frame: Change of mean scores of fatigue from baseline to immediately after intervention
Mean of Insomnia scores
Time frame: Change of mean scores of insomnia from baseline to immediately after intervention
Mean in Post-Traumatic growth scores
Time frame: Change of mean scores of post-traumatic growth from baseline to immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 40595087Garcia-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.
- Derived from this study: PubMed 35664159Garcia-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.
- Individual participant dataSharing planned: No. not applicable for this essay
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy + app and Acceptance and commitment therapy in people with Cancer, run by Francisco Garcia Torres at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of Psychological flexibility scores (time frame: Change of mean scores of psychological flexibility from baseline to immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05126823, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.