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

NCT06266182 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

  • Hematopoietic Cell Transplantation Recipient
  • Acceptance and Commitment Therapy

Interventions

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.

Sponsors & Collaborators

  • National Science Centre, Poland

    collaborator OTHER_GOV
  • University of Social Sciences and Humanities, Warsaw

    lead OTHER

Principal Investigators

  • Aleksandra Kroemeke, PhD · SWPS University (University of Social Sciences and Humanities)

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2025-12-31
Completion
2026-04-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266182 on ClinicalTrials.gov