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Female Breast CancerI-CAN-ACTNCT05374161

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

A study testing Acceptance and Commitment Therapy in people with Female Breast Cancer and Depression, run by University of Cyprus at 1 site in Cyprus.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Female Breast Cancer, Depression, Pain
What is being tested?
Acceptance and Commitment Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteCyprus
Study dates
20 Jan 2022to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Maria Karekla, Ph.D. contact

0035722892100

mkarekla@ucy.ac.cy

Marianna Zacharia, M.Sc. contact

0035799794579

zacharia.marianna@ucy.ac.cy

Cyprus1 site, 1 recruiting

  • University of Cyprus

    Nicosia, Non-US/Non-Canadian, 1678

    Maria Karekla, PhD, 22892100, mkarekla@ucy.ac.cy

    Recruiting

Other trials in Cyprus

About this study

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

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.

Read the 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:

  1. 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
Being tested
Acceptance and Commitment Therapy, Waitlist Control Group
Keywords
Female Breast Cancer, Physical Pain, Depression, Quality of Life, Brief ACT-based Intervention, RCT
Medical subject headings
Depression, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceptance and Commitment TherapyBehavioural

    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.

  • Waitlist Control GroupOther

    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).

Study groups in NCT05374161
Study groupRoleWhat they receive
Brief ACT-based interventionExperimentalA 6- week ACT intervention for depression and physical pain will be delivered.
Receives: Behavioral: Acceptance and Commitment Therapy
Waitlist control group (WL)OtherThe WL control group will receive treatment as usual, just like women in the experimental condition.
Receives: Other: Waitlist Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up

  2. 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.

    Measured: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up

  3. 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.

    Measured: 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).

  4. 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.

    Measured: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up

  5. 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.

    Measured: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up

  6. 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.

    Measured: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up

  7. 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.

    Measured: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up

  8. 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".

    Measured: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up

  9. 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.

    Measured: pre-treatment, mid-intervention assessment, post-treatment, 1-month follow-up, 3-month follow-up

  10. 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.

    Measured: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up

  11. 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.

    Measured: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2022
  2. Study start20 Jan 2022
  3. Primary completion30 May 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

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
A 2-arm RCT will be conducted (brief ACT-based intervention vs waitlist control group).
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05374161
Sponsor's protocol ID
K3_K1_2
Acronym
I-CAN-ACT
Status last verified
May 2022
First submitted
4 Jan 2022
Last updated
16 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22035996

  • 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.

    PubMed 9060536

  • 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.

    PubMed 8445433

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

  • 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.

  • 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

  • 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.

    PubMed 24411117

  • 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

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

  • 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

  • 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

  • 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.

    PubMed 25181605

  • 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.

    PubMed 18325093

  • 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.

    PubMed 26091250

  • 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.

    PubMed 11150906

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy in people with Female Breast Cancer and Depression, run by University of Cyprus at 1 site in Cyprus.

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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2022. 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 Cyprus. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria Karekla, Ph.D. (0035722892100, mkarekla@ucy.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Functional Assessment of Cancer Therapy - Breast (FACT-B; Brady et al., 1997) (time frame: pre-intervention, mid-intervention assessment (at the end of week 3), post-intervention (at 6 weeks), 1-month follow-up, 3-month follow-up). 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 NCT05374161, which also lists 24 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 16 May 2022.

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