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

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

NCT ID: NCT06266182

Condition: Hematopoietic Cell Transplantation Recipient
Acceptance and Commitment Therapy

Conditions: 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

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: Acceptance and Commitment Therapy
Description: 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.
Arm group label: ACT intervention

Other name: ACT-based intervention

Other name: ACT

Intervention type: Behavioral
Intervention name: Education
Description: 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.
Arm group label: Education

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).

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Maria Skłodowska-Curie National Research Institute of Oncology Gliwice Branch, Department of Bone Marrow Transplantation and Oncohematology

Address:
City: Gliwice
Zip: 44-102
Country: Poland

Status: Recruiting

Contact:
Last name: Małgorzata Sobczyk-Kruszelnicka, MD

Phone: 011 48 322788520
Email: malgorzata.sobczyk-kruszelnicka@gliwice.nio.gov.pl

Investigator:
Last name: Małgorzata Sobczyk-Kruszelnicka, MD
Email: Sub-Investigator

Start date: March 6, 2024

Completion date: April 2026

Lead sponsor:
Agency: University of Social Sciences and Humanities, Warsaw
Agency class: Other

Collaborator:
Agency: National Science Centre, Poland
Agency class: Other

Source: University of Social Sciences and Humanities, Warsaw

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06266182