An Intervention for Female Breast CANcer: Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain

Study Overview
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Brief Summary
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As a result of the cancer diagnosis and medical therapies, women with breast cancer often encounter debilitating cooccurring psychological and physical symptoms. While pain constitutes one of the most common adverse physical side effects of medical treatment reported by breast cancer patients, the most prevalent psychological symptom they seek psychological help for is depressive symptoms. Acceptance and Commitment Therapy (ACT) in psychosocial oncology care may be particularly beneficial in targeting depression and cancer-related pain. The aim of the I-CAN-ACT project is to examine in a RCT the efficacy of a brief ACT-based intervention for both depression and physical pain (6 online sessions) compared to a waitlist control on various outcomes in women with breast cancer. Outcomes will include quality of life, physical pain intensity and interference, depression, and anxiety in women with breast cancer. These will be assessed at post-treatment and at the 1-month, 3-month, 6-month and 1 year follow-ups (for Marianna Zacharia's PhD thesis, results will be presented until the 3-month follow-up). Also, the Acceptability and Feasibility of the intervention will be assessed. That is, participants' treatment acceptability and adherence to the brief ACT intervention in terms of retention, treatment engagement and satisfaction with each session and with the overall treatment will be assessed. Participants' reasons for dropout will be recorded.

Detailed Description
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As a result of the cancer diagnosis and medical therapies, women with breast cancer often encounter debilitating cooccurring psychological and physical symptoms. While pain constitutes one of the most common adverse physical side effects of medical treatment reported by breast cancer patients, the most prevalent psychological symptom they seek psychological help for is depressive symptoms. Acceptance and Commitment Therapy (ACT) in psychosocial oncology care may be particularly beneficial in targeting depression and cancer-related pain. The aim of the I-CAN-ACT project is to examine in a RCT the efficacy of a brief ACT-based intervention for both depression and physical pain (6 online sessions) compared to a waitlist control on various outcomes in women with breast cancer. Based on preliminary empirical findings, the hypotheses of this study are: The group ACT-based intervention will demonstrate significantly greater improvements in the primary outcome (quality of life: physical well-being, emotional well-being, social/family well-being, functional well-being, additional concerns for breast cancer) compared to the WL at post-treatment, at 1-month and 3-month follow-ups. The group ACT-based intervention will demonstrate significantly greater reductions in the secondary outcomes (pain intensity and interference, depression and anxiety) compared to the WL at post-treatment, at 1-month and 3-month follow-ups. The group ACT-based intervention will present significant improvements in the ACT components (acceptance, cognitive defusion, contact with the present moment, self-as-context, self-compassion, values clarification, committed action) compared to the WL at post-treatment, at 1-month and 3-month follow-ups. It is hypothesized that the mechanisms/core processes, via which ACT is expected to exert its effects, will mediate pre to 1-month follow-up and pre to 3-month follow-up quality of life scores (primary outcome) for the ACT-based intervention. It is hypothesized that the mechanisms/core processes, via which ACT is expected to exert its effects, will mediate pre to 1-month follow-up and pre to 3-month follow-up scores of secondary outcomes (physical pain intensity and interference, depression, anxiety). Completing any ACT skill in a session will lead to improvement in that specific skill (ACT proposed mechanism of action) in-the-moment within each week of the group ACT-based intervention. This is the first study to: i. examine the longitudinal effects (1-month and 3-month follow ups) of an ACT intervention on both depression and physical pain, which often co-occur in female breast cancer patients ii. examine all the processes of change in ACT responsible for effective treatment outcomes in women with breast cancer iii. offer a brief ACT intervention for this population iv. assess participants' treatment acceptability and adherence to an ACT-based intervention in terms of retention, treatment engagement and satisfaction with treatment for this population v. assess therapists' fidelity/adherence to the protocol and the ACT approach as well as the therapists' competence, when implementing a RCT for women with breast cancer vi. employ the innovative methodological approach of Ecological Momentary Assessment through a mobile application in addition to standardized pre post-follow-up self-report questionnaires to assess changes in the ACT processes as a result of intervention

Official Title
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Efficacy of a Brief Intervention for Female Breast CANcer Based on Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain: A 2-Arm Randomized Clinical Trial

Conditions
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Depression, Female Breast Cancer, Pain

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy
* Other: Waitlist Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understanding and speaking fluently in Greek Age 18 and older Education level should be at least elementary school (ability to read and write) Diagnosed breast cancer in stages I, II or III Underwent breast surgery Experiencing at least mild depression and at least mild intensity and interference of physical pain Exclusion Criteria: A history of metastasis (stage IV cancer) Significant cognitive impairment assessed using the Mini-mental State Examination (MMSE score < 20) A history of severe psychopathology (i.e., psychosis), suicidal ideation, substance use problems before breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

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: A 2-arm RCT will be conducted (brief ACT-based intervention vs waitlist control group).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief ACT-based intervention<br>A 6- week ACT intervention for depression and physical pain will be delivered. | Behavioral: Acceptance and Commitment Therapy<br>* The ACT-based intervention will be delivered in a group format. Due to the COVID-19 pandemic and given that breast cancer patients are considered a vulnerable population, the intervention will be administered online through a GDPR compliant platform. The six, weekly, 90-minute treatment sessions (total of 9 hours) will be conducted in groups of approximately 8-10 participants and one therapist.<br>|
| Other: Waitlist control group (WL)<br>The WL control group will receive treatment as usual, just like women in the experimental condition. | Other: Waitlist Control Group<br>* Participants randomized to the WL condition will be asked to continue receiving the services they receive from anti-cancer associations (receiving care from nurses, or/and support from social workers, or/and physiotherapy or/and individual psychological support from licensed psychologists just like the women in the experimental condition).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Functional Assessment of Cancer Therapy - Breast (FACT-B; Brady et al., 1997) | It consists of five well-being domains: physical well-being (7 items), emotional well-being (6 items), social/family well-being (7 items) and functional well-being (7 items), which constitute the Functional Assessment of Cancer Therapy - General (FACT-G; Cella et al., 1993) and the additional concerns for breast cancer, the Breast Cancer Subscale (BCS; 10 items). Each item on the FACT-B is rated on a five-point scale ranging from 0 = not at all to 4 = very much. The total score can range from 0 to 144 and is the sum of scores from all five subscales. Higher scores reveal greater perceived quality of life. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Hospital Anxiety and Depression Scale (HADS; Greek version: Mystakidou et al., 2004 and Michopoulos et al., 2008; English version: Zigmond & Snaith, 1983) | It is a 14-item self-report measure of psychological distress in individuals with physical health problems (Johnston, Pollard, & Hennessey, 2000; Roberts, Bonnici, Mackinnon, & Worcester, 2001). Scale scores are thought to be unbiased by the existence of bodily illness (Zigmond & Snaith, 1983). HADS assesses anxiety (7 items) and depression (7 items) independently, rated on a four-point scale (range= 0-3; different anchors per item), with scores ranging between 0 and 21 per subscale. Higher scores indicate higher levels of anxiety and depression. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 
| Change in the Brief Pain Inventory (BPI; Cleeland, 1989) | It was initially developed in English in the USA (Cleeland, 1989) and has been validated in several languages. The Greek Brief Pain Inventory- Short Form (G-BPI; Mystakidou et al., 2001) is a 9-item self-report questionnaire used to assess pain intensity and pain interference in cancer patients. Patients are requested to rate their worst, least, average and current pain intensity and report current medications/treatment along with their perceived effectiveness on a 10-point scale, ranging from 0 = no pain to 10 = pain as bad as you can imagine. Also, they are asked to rate the extent to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life on a 10-point scale, ranging from 0 = does not interfere to 10 = completely interferes. Higher scores indicate higher pain intensity and higher pain interference. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 
| Change in the Psyflex (Gloster et al., 2021) | The PsyFlex (Gloster et al., 2021) is an 8-item self-report measure that assesses all six processes/skills of the ACT Hexaflex; that is psychological flexibility. Items of the PsyFlex are rated on a 5-point Likert type scale, ranging from 1 very often to 5 very rarely. Higher scores indicate lower levels of psychological flexibility. | A mobile application will be used, which will prompt the patients in the ACT intervention to answer the eight items of the PsyFlex. These prompts will take place twice per day for the six weeks of the intervention (Ecological Momentary Assessment). | 
| Change in the Greek Acceptance and Action Questionnaire - II (AAQ-II; Greek version: Karekla & Michaelides, 2017; English version: Bond et al., 2011) | The Greek Acceptance and Action Questionnaire - II (AAQ-II; Greek version: Karekla & Michaelides, 2017; English version: Bond et al., 2011) is a 7-item self-report measure of experiential avoidance or its reverse, psychological flexibility. Items are rated on a 7-point Likert scale, ranging from 1 = never true to 7 = always true. Higher scores indicate greater experiential avoidance while lower scores indicate greater psychological flexibility. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 
| Change in the Cognitive Fusion Questionnaire (CFQ; Greek version: Zacharia et al., 2021; English version; Gillanders et al., 2014) | The Cognitive Fusion Questionnaire (CFQ; Greek version: Zacharia et al., 2021; English version: Gillanders et al., 2014) is a brief, 7-item self-report scale of cognitive fusion. Items are rated on a 7-point Likert scale (range from 1 = Never true to 7 = Always true. Higher scores indicate higher levels of cognitive fusion. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 
| Change in the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman, Hayes, Kumar, Greeson, & Laurenceau, 2007) | The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman, Hayes, Kumar, Greeson, & Laurenceau, 2007) is a 12-item self-report measure of mindfulness, designed based on the definition of mindfulness as the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment to moment (Kabat-Zinn, 2003, p. 145). Items are rated on a 4-point Likert scale, ranging from 1 rarely/not at all to 4 almost always. Authors suggest the use of a total score. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 
| Change in the Self-as-Context Scale (SACS; Zettle et al., 2018) | The Self-as-Context Scale (SACS; Zettle et al., 2018) is a brief (10-item) self-report scale of contextual self. Items are rated on a 7-point Likert scale, ranging from 1 Strongly disagree to 7 Strongly Agree. Higher scores indicate higher levels of Centering, Transcending and Contextual Self. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 
| Change in the Valuing Questionnaire (VQ; Smout, Davies, Burns, & Christie, 2014) | The Valuing Questionnaire (VQ; Smout, Davies, Burns, & Christie, 2014) is a 10-item measure that assesses the degree to which the person lives and acts in accordance to his/her values. Items are rated on a 7-point Likert type scale, ranging from 0 never true to 6 always true. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 
| Change in the Committed Action Questionnaire (CAQ; McCracken et al., 2015) | Committed Action Questionnaire (CAQ; McCracken et al., 2015), is an 8-item scale that examines goal-directed behaviors. Items are rated on a 7-point Likert-type scale, ranging from 0 never true to 6 always true. Negatively worded items are reverse scored in order to indicate higher levels of committed actions. Higher scores indicate a higher tendency to persist in value-driven actions. | pre-treatment, mid-intervention assessment, post-treatment, 1-month follow-up, 3-month follow-up | 
| Change in the Self-Compassion Scale (SCS; English version: Neff, 2003; Greek version: Mantzios, Wilson, & Giannou, 2015) | The Self-Compassion Scale (SCS; English version: Neff, 2003; Greek version: Mantzios, Wilson, & Giannou, 2015) is a 26-item scale that measures six constituents of self-compassion. Items are rated on a 5-point Likert-type scale, ranging from Almost Never to Almost Always. A total self-compassion score is calculated after reversing the negative subscale items and adding all subscale scores. Higher scores indicate higher self-compassion. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 
| Change in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue (EORTC QLQ-FA12; Weis et al., 2017) | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue (EORTC QLQ-FA12, abbreviated as FA12) will be used as a measure of cancer related fatigue (Weis et al., 2017). It is comprised of 12 items, with four response categories for each item, coded with values from 1 to 4. Higher scores indicate greater fatigue. | pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female Breast Cancer, Physical Pain, Depression, Quality of Life, Brief ACT-based Intervention, RCT