Clinical trial NCT05374161: An Intervention for Female Breast CANcer: Acceptance and Commitment Therapy (I-CAN-ACT) for Depression and Physical Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Female Breast Cancer
Depression
Pain
Keywords: Female Breast Cancer
Physical Pain
Depression
Quality of Life
Brief ACT-based Intervention
RCT
Lead sponsor: University of Cyprus
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2-arm RCT will be conducted (brief ACT-based intervention vs waitlist control group).
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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).
6. 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Functional Assessment of Cancer Therapy - Breast (FACT-B; Brady et al., 1997)
timeFrame: 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 outcomes:
measure: 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)
timeFrame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
measure: Change in the Brief Pain Inventory (BPI; Cleeland, 1989)
timeFrame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
measure: Change in the Psyflex (Gloster et al., 2021)
timeFrame: 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).
measure: Change in the Greek Acceptance and Action Questionnaire - II (AAQ-II; Greek version: Karekla & Michaelides, 2017; English version: Bond et al., 2011)
timeFrame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
measure: Change in the Cognitive Fusion Questionnaire (CFQ; Greek version: Zacharia et al., 2021; English version; Gillanders et al., 2014)
timeFrame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
measure: Change in the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman, Hayes, Kumar, Greeson, & Laurenceau, 2007)
timeFrame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
measure: Change in the Self-as-Context Scale (SACS; Zettle et al., 2018)
timeFrame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
measure: Change in the Valuing Questionnaire (VQ; Smout, Davies, Burns, & Christie, 2014)
timeFrame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
measure: Change in the Committed Action Questionnaire (CAQ; McCracken et al., 2015)
timeFrame: pre-treatment, mid-intervention assessment, post-treatment, 1-month follow-up, 3-month follow-up
measure: Change in the Self-Compassion Scale (SCS; English version: Neff, 2003; Greek version: Mantzios, Wilson, & Giannou, 2015)
timeFrame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
measure: Change in The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Fatigue (EORTC QLQ-FA12; Weis et al., 2017)
timeFrame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up
Other outcomes:
measure: ACT Fidelity Measure (ACT-FM; O'Neill, Latchford, McCracken, & Graham, 2019)
timeFrame: The research assistant will be asked to complete the ACT-FM at the end of each of the six sessions.
measure: Change in the Session Rating Scale Version 3 (SRS V.3; Duncan et al., 2003)
timeFrame: Participants will be asked to complete the SRS V.3 after the end of each of the six sessions.
measure: Treatment Acceptability and Adherence: Treatment Acceptability/Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)
timeFrame: post-intervention (at 6 weeks)
Locations:
city: Nicosia
country: Cyprus
facility: University of Cyprus
state: Non-US/Non-Canadian
Study officials:
affiliation: ACThealthy Lab, University of Cyprus
name: Maria Karekla, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
citation: Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974.
citation: Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
citation: Cleeland, C. S. (1989). Measurement of pain by subjective report. Advances in Pain Research and Therapy, 12, 391-403.
citation: Duncan, B. L., Miller, S. D., Sparks, J. A., Claud, D. A., Reynolds, L. R., Brown, J., & Johnson, L. D. (2003). The Session Rating Scale: Preliminary psychometric properties of a "working" alliance measure. Journal of Brief Therapy, 3(1), 3-12.
citation: Feldman, G., Hayes, A., Kumar, S., Greeson, J., & Laurenceau, J. P. (2007). Mindfulness and emotion regulation: The development and initial validation of the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Journal of Psychopathology and Behavioral Assessment, 29(3), 177-190. https://doi.org/10.1007/s10862-006-9035-8
citation: Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
citation: Gloster, A. T., Block, V. J., Klotsche, J., Villanueva, J., Rinner, M. T., Benoy, C., ... & Bader, K. (2021). Psy-flex: A contextually sensitive measure of psychological flexibility. Journal of Contextual Behavioral Science, 22, 13-23. https://doi.org/10.1016/j.jcbs.2021.09.001
citation: Kabat-Zinn, J. (2003). Mindfulness-based stress reduction (MBSR). Constructivism in the Human Sciences, 8(2), 73-83.
citation: Karekla, M., & Michaelides, M. P. (2017). Validation and invariance testing of the Greek adaptation of the Acceptance and Action Questionnaire-II across clinical vs. nonclinical samples and sexes. Journal of Contextual Behavioral Science, 6(1), 119- 124. https://doi.org/10.1016/j.jcbs.2016.11.006
citation: Mantzios, M., Wilson, J. C., & Giannou, K. (2015). Psychometric properties of the Greek versions of the self-compassion and mindful attention and awareness scales. Mindfulness, 6(1), 123-132. https://doi.org/10.1007/s12671-013-0237-3
citation: McCracken LM, Chilcot J, Norton S. Further development in the assessment of psychological flexibility: a shortened Committed Action Questionnaire (CAQ-8). Eur J Pain. 2015 May;19(5):677-85. doi: 10.1002/ejp.589. Epub 2014 Sep 2.
citation: Michopoulos I, Douzenis A, Kalkavoura C, Christodoulou C, Michalopoulou P, Kalemi G, Fineti K, Patapis P, Protopapas K, Lykouras L. Hospital Anxiety and Depression Scale (HADS): validation in a Greek general hospital sample. Ann Gen Psychiatry. 2008 Mar 6;7:4. doi: 10.1186/1744-859X-7-4.
citation: Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19.
citation: Mystakidou K, Mendoza T, Tsilika E, Befon S, Parpa E, Bellos G, Vlahos L, Cleeland C. Greek brief pain inventory: validation and utility in cancer pain. Oncology. 2001;60(1):35-42. doi: 10.1159/000055294.
citation: Mystakidou K, Tsilika E, Parpa E, Katsouda E, Galanos A, Vlahos L. The Hospital Anxiety and Depression Scale in Greek cancer patients: psychometric analyses and applicability. Support Care Cancer. 2004 Dec;12(12):821-5. doi: 10.1007/s00520-004-0698-y. Epub 2004 Oct 6.
citation: Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and Identity, 2(3), 223-250. https://doi.org/10.1080/15298860309027
citation: O'Neill, L., Latchford, G., McCracken, L. M., & Graham, C. D. (2019). The development of the Acceptance and Commitment Therapy Fidelity Measure (ACT-FM): A delphi study and field test. Journal of Contextual Behavioral Science, 14, 111-118. https://doi.org/10.1016/j.jcbs.2019.08.008
citation: Roberts SB, Bonnici DM, Mackinnon AJ, Worcester MC. Psychometric evaluation of the Hospital Anxiety and Depression Scale (HADS) among female cardiac patients. Br J Health Psychol. 2001 Nov;6(Part 4):373-383. doi: 10.1348/135910701169278.
citation: Smout, M., Davies, M., Burns, N., & Christie, A. (2014). Development of the valuing questionnaire (VQ). Journal of Contextual Behavioral Science, 3(3), 164-172. https://doi.org/10.1016/j.jcbs.2014.06.001
citation: Weis J, Tomaszewski KA, Hammerlid E, Ignacio Arraras J, Conroy T, Lanceley A, Schmidt H, Wirtz M, Singer S, Pinto M, Alm El-Din M, Compter I, Holzner B, Hofmeister D, Chie WC, Czeladzki M, Harle A, Jones L, Ritter S, Flechtner HH, Bottomley A; EORTC Quality of Life Group. International Psychometric Validation of an EORTC Quality of Life Module Measuring Cancer Related Fatigue (EORTC QLQ-FA12). J Natl Cancer Inst. 2017 May 1;109(5). doi: 10.1093/jnci/djw273.
citation: Zacharia, M., Ioannou, M., Theofanous, A., Vasiliou, V. S., & Karekla, M. (2021). Does Cognitive Fusion show up similarly across two behavioral health samples? Psychometric properties and invariance of the Greek-Cognitive Fusion Questionnaire (G-CFQ). Journal of Contextual Behavioral Science. https://doi.org/10.1016/j.jcbs.2021.01.003
citation: Zettle, R. D., Gird, S. R., Webster, B. K., Carrasquillo-Richardson, N., Swails, J. A., & Burdsal, C. A. (2018). The Self-as-Context Scale: Development and preliminary psychometric properties. Journal of Contextual Behavioral Science, 10, 64-74. https://doi.org/10.1016/j.jcbs.2018.08.010
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.