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

NCT05374161 | Unknown DMC

• 1 other identifier: K3_K1_2
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Breast Cancer; Depression; Pain

Keywords

Female Breast Cancer; Physical Pain; Depression; Quality of Life; Brief ACT-based Intervention; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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)

  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)

  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)

  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)

  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)

  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 (3)

• ACT Fidelity Measure (ACT-FM; O'Neill, Latchford, McCracken, & Graham, 2019)

  The research assistant will be asked to complete the ACT-FM at the end of each of the six sessions.

• Change in the Session Rating Scale Version 3 (SRS V.3; Duncan et al., 2003)

  Participants will be asked to complete the SRS V.3 after the end of each of the six sessions.

• Treatment Acceptability and Adherence: Treatment Acceptability/Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)

  post-intervention (at 6 weeks)

Study Arms (2)

Brief ACT-based intervention

EXPERIMENTAL

A 6- week ACT intervention for depression and physical pain will be delivered.

Behavioral: Acceptance and Commitment Therapy

Waitlist control group (WL)

OTHER

The WL control group will receive treatment as usual, just like women in the experimental condition.

Other: Waitlist Control Group

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Brief ACT-based intervention

Waitlist Control Group OTHER

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).

Waitlist control group (WL)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: women with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cyprus: lead

Study Sites (1)

University of Cyprus

Nicosia, Non-US/Non-Canadian, 1678, Cyprus

RECRUITING

Related Publications (24)

• 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.

  PMID: 22035996 BACKGROUND

• 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.

  PMID: 9060536 BACKGROUND

• 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.

  PMID: 8445433 BACKGROUND

• Cleeland, C. S. (1989). Measurement of pain by subjective report. Advances in Pain Research and Therapy, 12, 391-403.

  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24411117 BACKGROUND

• 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

  BACKGROUND

• Kabat-Zinn, J. (2003). Mindfulness-based stress reduction (MBSR). Constructivism in the Human Sciences, 8(2), 73-83.

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25181605 BACKGROUND

• 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.

  PMID: 18325093 BACKGROUND

• 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.

  PMID: 26091250 BACKGROUND

• 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.

  PMID: 11150906 BACKGROUND

• 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.

  PMID: 15480813 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 12614511 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28376231 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

Related Links

• ACThealthy Lab, University of Cyprus

MeSH Terms

Conditions

Depression; Pain

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maria Karekla, Ph.D.

  ACThealthy Lab, University of Cyprus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Karekla, Ph.D.

CONTACT

0035722892100; mkarekla@ucy.ac.cy

Marianna Zacharia, M.Sc.

CONTACT

0035799794579; zacharia.marianna@ucy.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A 2-arm RCT will be conducted (brief ACT-based intervention vs waitlist control group).

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: May 16, 2022
• Study Start: January 20, 2022
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)