The Effect of an Online ACT Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation

The Effect of an Online Acceptance and Commitment Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation: a Randomized Controlled Trial Enhanced With a Single-case Experimental Design

This trial aimed to test internet-based Acceptance and Commitment Therapy (ACT) intervention to induce a meaning-making process in cancer patients following hematopoietic cell transplantation (HCT). ACT includes identifying personal values and engaging in activities consistent with these values, developing acceptance, as well as focusing on the present moment or performing activities with greater awareness. In total, 192 patients following the first (autologous or allogeneic) HCT will be randomly assigned in equal numbers to either the ACT intervention or an education session. Participants in both conditions will take part in 14-day training (about 5-10 minutes a day). The outcomes will be measured at baseline, during the intervention, immediately, 1 month, and 3 months after the intervention. Moreover, 6-9 additional participants will be randomly assigned to pre-intervention measurement length (1-3 weeks) before completing ACT intervention, followed by 7-day observations at the 2nd and 3rd post-intervention measure. The researchers hypothesized that ACT intervention would foster a meaning-making process and thus reduce distress induced by the discrepancy between global and situational meaning as compared to education.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic Cell Transplantation Recipient; Acceptance and Commitment Therapy
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy; Behavioral: Education

Detailed Description

This trial evaluates the feasibility, acceptability, and preliminary efficacy of self-help internet-based Acceptance and Commitment Therapy (ACT) intervention on meaning-related distress as well as secondary outcomes in patients following hematopoietic cell transplantation (HCT). Randomized controlled trial (RCT) will be enhanced with a single-case experimental design (SCED).

Recruitment will take place at a single center, after elective admission to the bone marrow transplantation and oncohematology unit due to HCT before the start of conditioning treatment. Recruitment will take place on average on the 2nd day after admission. Every two days, the transplant coordinator and physician (members of the research team) will review the lists of patients enrolled for HCT. Those who meet the inclusion criteria will be initially informed of the purpose of the study and invited for an extensive briefing by a recruiter (member of the research team). Patients will also be allowed to ask any remaining questions about the aim of the study and the study procedures. After receiving an extensive briefing, all patients who give written informed consent will proceed with baseline. Data will be collected via a self-reported survey on a mobile device. Clinical data will be obtained from the medical records. All participants will receive written user instructions for the daily sessions and measurements.

In RCT, participants will be randomly assigned in a double-blinded manner to ACT intervention and education conditions at a ratio of 1:1 by a trial coordinator (member of the research team). Randomization will be stratified by type of transplant. Participants and researchers analyzing data will be blind to the allocation of the participants to the conditions. Participants allocated to the ACT intervention will receive online ACT-based intervention within 14 days after hospital discharge. Each day's intervention will consist of an educational and practical part (standard ACT activity) followed by a debrief. On some days, participants will also receive additional exercise (optional). The whole intervention will be tailored to the context of the disease and treatment. During the same period, participants allocated to the education will receive an online guide to post-HCT recommendations. The intervention/education will be discontinued by participants at any time without any negative consequences. During the intervention/education, participants will fill in a short questionnaire assessing potential mediator variables each day, at the beginning of every online session. Participants will receive daily reminders about the intervention/education. Also, direct technical support will be available 24/7. If participants fail to complete study assessments, motivational reminders will be sent by email. If participants drop out or stop using the intervention, they will be asked for the reason(s) why they decided to quit the intervention and/or study.

In SCED, all participants will take part in the online ACT intervention and daily surveys at the 2nd and 3rd post-intervention assessments.

Feasibility will be examined via attrition and adherence rates, as well as questions about intervention engagement. Acceptability will be measured by intervention satisfaction and evaluation (attractiveness and easiness).

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksandra Kroemeke, PhD; Phone Number: 011 48 225179824; Email: akroemeke@swps.edu.pl

Study Locations

• Poland
  • Gliwice, Poland, 44-102
    • Recruiting
    • Maria Skłodowska-Curie National Research Institute of Oncology Gliwice Branch, Department of Bone Marrow Transplantation and Oncohematology
    • Contact: Małgorzata Sobczyk-Kruszelnicka, MD; Phone Number: 011 48 322788520; Email: malgorzata.sobczyk-kruszelnicka@gliwice.nio.gov.pl
    • Sub-Investigator: Małgorzata Sobczyk-Kruszelnicka, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Qualification for the first autologous or allogeneic HCT due to hematologic malignancies or solid tumors
• Age ≥ 18 years
• Signed written informed consent
• Ability to read and write in Polish
• Daily access to the Internet by computer and/or mobile device

Exclusion Criteria:

• Major psychiatric or cognitive disorder that would impede providing informed consent and study participation
• Inability to cooperate and give informed consent
• Hearing, seeing, or movement impairment that precludes participation
• Current participation in any form of psychotherapy
• No access to the Internet
• No access to a computer and/or mobile device
• Inability to use a computer and/or mobile device and the Internet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT intervention; Participants in the ACT intervention arm will learn new adaptive ways to cope with difficulties (including difficult thoughts or feelings).	Behavioral: Acceptance and Commitment Therapy; ACT intervention will start on the second day after hospital discharge and will take 14 days (+ day 0 with organizational information). Each day, participants will receive a web-based intervention consisting of educational and practical tasks/activities. Participants will learn to recognize moments of choice (actions that lead towards values or away from them) and to use attention flexibly to free themselves from the power of thoughts, to open up and accept emotions, and to be able to determine what is important and take action in line with values. All of the tasks will be available in written form and audio. The ACT intervention is built from standard ACT exercises.; Other Names: ACT; ACT-based intervention
Other: Education; Participants in the Education arm will become familiar with post-HCT recommendations. This will be a minimally enhanced usual care.	Behavioral: Education; Education will start on the second day after hospital discharge and will take 14 days (+ day 0 with organizational information). Each day, participants will receive information about post-transplant prescriptions along with exercises to support the implementation. Participants will learn about nutrition, personal hygiene, preventing infections, coping with fatigue, resuming activity, rest and sleep, engaging in social interactions, and sexual health. The content is prepared based on available guides for HCT recipients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distress (Global Meaning Violation Scale; GMVS)	The GMVS measures meaning-related distress. It is a 12-item questionnaire (from the original, the item "health" was removed due to the context of the study) that assesses belief (5 items) and goal violations (7 items) in response to stressors on a 5-point scale ranging from 1 (not at all) to 5 (very much). The overall score is calculated by summing the scores of all 12 items, with a possible range of 12-60. Higher scores indicate greater meaning-related distress (greater global meaning violation).	Change from baseline to immediately, 1 month and 3 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illness perception (Brief-Illness Perception Questionnaire; B-IPQ)	The B-IPQ measures cognitive and emotional representations of illness. It is an 8-item questionnaire that assesses cognitive illness representation, emotional illness representation, and illness comprehensibility representation on a 0-10 point scale. The total score is calculated by summing the scores of all 8 items, with a possible range of 0-80. Higher scores indicate more threatening perception of the illness.	Change from baseline to immediately, 1 month and 3 months after intervention
Global meaning (Meaning in Life Questionnaire; MLQ)	The MLQ measures meaning in life. It is a 10-item questionnaire that assesses the Presence of meaning in life and the Searches for meaning in life on a 7-point scale ranging from 1 (absolutely untrue) to 7 (absolutely true). The subscale scores are calculated by summing the scores of relevant items (5 per subscale), with a possible range of 5-35. Higher scores indicate a greater Presence of meaning in life and Search for meaning in life, respectively.	Change from baseline to immediately, 1 month and 3 months after intervention
Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9)	The CompACT-9 measures psychological flexibility. It is a 9-item questionnaire that assesses Openness to Experience, Behavioral Awareness, and Valued Action on a 7-point scale ranging from 0 (strongly disagree) to 6 (strongly agree). The overall score is calculated by summing the scores of all 9 items, with a possible range of 0-36. Higher scores indicate higher psychological flexibility (greater openness to experience and willingness to experience internal events such as thoughts, feelings, sensations, etc. without trying to control or avoid them; greater behavioral awareness and mindful attention to current actions; greater engagement in valued actions and meaningful activity).	Change from baseline to immediately, 1 month and 3 months after intervention
Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items)	The CSE measures a perceived self-efficacy for coping with challenges and threats. This study used 6 items tailored to the context of the study (2 per subscale: Problem-focused Coping, Emotion-focused Coping, and Social Support Coping) assessed on a 5-point scale ranging from 1 (not at all) to 5 (strongly). The overall score is calculated by summing the scores of all 6 items, with a possible range of 6-30. Higher scores indicate greater coping self-efficacy.	Change from baseline to immediately, 1 month and 3 months after intervention
Deliberate meaning-making (Core Beliefs Inventory; CBI)	The CBI is a 10-item questionnaire that assesses deliberate meaning-making coping on a 6-point scale ranging from 0 (not at all) to 5 (to a very degree). The total score is calculated by summing the scores of all 10 items, with a possible range of 0-45. Higher scores indicate greater deliberate searching for meaning.	Change from baseline to immediately, 1 month and 3 months after intervention
Automatic meaning-making (Event-Related Rumination Inventory; ERRI - intrusive ruminations subscale)	The intrusive ruminations subscale of the ERRI measures automatic meaning-making coping. It is a 10-item subscale that assesses intrusive ruminations on a 4-point scale ranging from 0 (not at all) to 3 (often). The total score is calculated by summing the scores of all 10 items, with a possible range of 0-30. Higher scores indicate greater automatic searching for meaning.	Change from baseline to immediately, 1 month and 3 months after intervention
Post-traumatic growth (the "current standing" Post-Traumatic Growth Inventory-Short Form; C-PTGI-SF )	The C-PTGI-SF measures psychological well-being in cross-sectional assessment, as well as posttraumatic growth (element of meanings made) in multiple assessments. It is a 10-item questionnaire that assesses psychological well-being on a 6-point scale ranging from 0 (not at all) to 5 (to a very great degree). The total score is calculated by summing the scores of all 10 items, with a possible range of 0-50. Higher scores indicate better well-being.	Change from baseline to immediately, 1 month and 3 months after intervention
Meanings made (Meaning of Loss Codebook; MLC)	The MLC evaluates meanings made. It is a 3-item tool that assesses sense made, benefit finding, and sense of identity change on a 5-point scale ranging from 1 (not at all) to 5 (to a very great degree). The overall score is calculated by summing the scores of all 3 items, with a possible range of 3-15. Higher scores indicate greater meanings made.	Change from baseline to immediately, 1 month and 3 months after intervention
Anxiety and depressive symptoms (Patient Health Questionnaire-4; PHQ-4)	The PHQ-4 is a 4-item questionnaire that assesses symptoms of anxiety (2 items) and depression (2 items) on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The subscale scores are calculated by summing the scores of 2 items, with a possible range of 0-6. Higher scores indicate higher levels of anxiety and depression symptoms, respectively. The total PHQ-4 score complements the subscale scores as an overall measure of symptom burden, as well as functional impairment and disability.	Change from baseline to immediately, 1 month and 3 months after intervention
Loneliness (The Revised UCLA Loneliness Scale; R-UCLA - selected items)	The R-UCLA measures perceived social isolation. This study used 5 items that assess the emotional and social aspects of loneliness on a 4-point scale ranging from 1 (never) to 4 (often or always). The total score is calculated by summing the scores of all 5 items, with a possible range of 5-20. Higher scores indicate greater loneliness.	Change from baseline to immediately, 1 month and 3 months after intervention
Loneliness (the Community Life Survey)	A direct question about loneliness from the Community Life Survey is used. The statement is assessed on a 4-point scale ranging from 1 (never) to 4 (often or always). A higher score indicates greater loneliness.	Change from baseline to immediately, 1 month and 3 months after intervention
Health-related quality of life (Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer; EORTC QLQ-C3)	The EORTC QLQ-C30 measures the health-related quality of life of cancer patients. It is a 30-item questionnaire that assesses physical, role, social, emotional, and cognitive functioning, as well as various symptoms, financial impact, and global quality of life. Twenty-eight items are rated on a 4-point scale ranging from 1 (not at all) to 4 (very much), while 2 items are rated on a 7-point scale ranging from 1 (very poor) to 7 (excellent). The overall score is calculated by summing the scores of all items, with a possible range of 0-100. Higher scores indicate better function and a higher quality of life.	Change from baseline to immediately, 1 month and 3 months after intervention
Daily subjective health (Daily Subjective Health Scale)	Daily subjective health is measured by a single-item statement "Generally, I can say my health today was …" on a 5-point scale ranging from 1 (bad) to 5 (excellent). Higher scores indicate greater daily physical health.	RCT: day-by-dy for 14 days during the intervention. SCED: for 7-21 days before intervention, day-by-dy for 14 days during the intervention, for 7 days immediately, 1 month, and 3 months after intervention
Daily affect (Daily Positive and Negative Affect Scale)	The Daily Positive and Negative Affect Scale is a 4-item questionnaire that consists of two positive (happy, cheerful) and two negative adjectives (sad, gloomy) rated on a 5-point scale ranging from 1 (not at all) to 5 (to a very great degree). The subscale scores are calculated by summing the scores of relevant items, with a possible range of 2-10. Higher scores indicate higher daily positive or negative affect.	RCT: day-by-dy for 14 days during the intervention. SCED: for 7-21 days before intervention, day-by-dy for 14 days during the intervention, for 7 days immediately, 1 month, and 3 months after intervention
Daily meaning-making (Event-Related Rumination Inventory-daily form; ERRI-daily form)	The ERRI-daily form measures deliberate and automatic meaning-making coping. It is a 4-item tool that assesses deliberate and intrusive ruminations on a 4-point scale ranging from 0 (not at all) to 3 (to a very great degree). The subscale scores are calculated by summing the scores of relevant items (2 per subscale), with a possible range of 0-6. Higher scores indicate greater deliberate or automatic searching for meaning.	RCT: day-by-dy for 14 days during the intervention. SCED: for 7-21 days before intervention, day-by-dy for 14 days during the intervention, for 7 days immediately, 1 month, and 3 months after intervention
Daily meanings made (Meaning of Loss Codebook-daily form; MCL-daily form)	The MLC-daily form measures daily meanings made. It is a 3-item tool that assesses daily sense made, benefit finding, and sense of identity change on a 5-point scale ranging from 1 (not at all) to 5 (to a very great degree). The overall score is calculated by summing the scores of all 3 items, with a possible range of 3-15. Higher scores indicate greater daily meanings made.	RCT: day-by-dy for 14 days during the intervention. SCED: for 7-21 days before intervention, day-by-dy for 14 days during the intervention, for 7 days immediately, 1 month, and 3 months after intervention
Daily psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-daily form; CompACT-daily form)	The CompACT-daily form is a 4-item tool that assesses daily psychological flexibility (i.e. daily Openness to experience - 2 items, daily Behavioral awareness - 1 item, and daily Valued action - 1 item) on a 7-point scale ranging from 0 (strongly disagree) to 6 (strongly agree). The overall score is calculated by summing the scores of all 4 items, with a possible range of 0-24. Higher scores indicate higher daily psychological flexibility (i.e. greater daily openness to experience and willingness to experience internal events such as thoughts, feelings, sensations, etc. without trying to control or avoid them; greater daily behavioral awareness and mindful attention to current actions; greater daily engagement in valued actions and meaningful activity).	RCT: day-by-dy for 14 days during the intervention. SCED: for 7-21 days before intervention, day-by-dy for 14 days during the intervention, for 7 days immediately, 1 month, and 3 months after intervention

Collaborators and Investigators

• Sponsor: University of Social Sciences and Humanities, Warsaw
• Collaborators: National Science Centre, Poland
• Investigators: Principal Investigator: Aleksandra Kroemeke, PhD, SWPS University (University of Social Sciences and Humanities)

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 10, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; hematopoietic cell transplantation; subjective well-being; cancer patients; web-based intervention; single-case experimental design; psychological flexibility; ACT-based intervention; meaning-making
• Other Study ID Numbers: 2020/39/B/HS6/01927

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The full protocol, dataset, statistical codes, and outputs will be made available at the Open Science Framework (OSF). Anonymized participant-level datasets will be publicly available, however, without demographics and clinical data due to privacy or ethical restrictions (the possibility of identification of participants).

The data will be stored for at least 5 years after the end of the project unless other regulations lengthen the need to store the data or it is not necessary due to other reasons (e.g. documentation of research results).

• IPD Sharing Time Frame: Beginning 3 months after publication without an end date.
• IPD Sharing Access Criteria: All those who will have an open link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No