Clinical trial NCT06266182: The Effect of an Online ACT Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic Cell Transplantation Recipient
Acceptance and Commitment Therapy
Keywords: cancer patients
hematopoietic cell transplantation
ACT-based intervention
web-based intervention
meaning-making
subjective well-being
psychological flexibility
randomized controlled trial
single-case experimental design
Lead sponsor: University of Social Sciences and Humanities, Warsaw
Sponsor class: OTHER
Collaborators: name: National Science Centre, Poland
First posted: 2024-02-20
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is enhanced by a single-case experimental design (SCED), in which all study participants will receive the same intervention (i.e., intervention study model: single group). In SCED, there is no masking. The estimated total number of participants to be enrolled in SCED is 6-9.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Distress (Global Meaning Violation Scale; GMVS)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
Secondary outcomes:
measure: Illness perception (Brief-Illness Perception Questionnaire; B-IPQ)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Global meaning (Meaning in Life Questionnaire; MLQ)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Deliberate meaning-making (Core Beliefs Inventory; CBI)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Automatic meaning-making (Event-Related Rumination Inventory; ERRI - intrusive ruminations subscale)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Post-traumatic growth (the "current standing" Post-Traumatic Growth Inventory-Short Form; C-PTGI-SF )
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Meanings made (Meaning of Loss Codebook; MLC)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Anxiety and depressive symptoms (Patient Health Questionnaire-4; PHQ-4)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Loneliness (The Revised UCLA Loneliness Scale; R-UCLA - selected items)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Loneliness (the Community Life Survey)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Health-related quality of life (Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer; EORTC QLQ-C3)
timeFrame: Change from baseline to immediately, 1 month and 3 months after intervention
measure: Daily subjective health (Daily Subjective Health Scale)
timeFrame: 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
measure: Daily affect (Daily Positive and Negative Affect Scale)
timeFrame: 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
measure: Daily meaning-making (Event-Related Rumination Inventory-daily form; ERRI-daily form)
timeFrame: 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
measure: Daily meanings made (Meaning of Loss Codebook-daily form; MCL-daily form)
timeFrame: 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
measure: Daily psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-daily form; CompACT-daily form)
timeFrame: 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
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Maria Skłodowska-Curie National Research Institute of Oncology Gliwice Branch, Department of Bone Marrow Transplantation and Oncohematology
Study officials:
affiliation: SWPS University (University of Social Sciences and Humanities)
name: Aleksandra Kroemeke, PhD
role: PRINCIPAL_INVESTIGATOR
References: