NCT06266182

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: University of Social Sciences and Humanities, Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hematopoietic Cell Transplantation Recipient
• Acceptance and Commitment Therapy

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-03-06
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2024-02-20
• Last updated: 2024-05-16

Locations

1 site across 1 country: Poland