RecruitingNot ApplicableNCT06266182

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


Sponsor

University of Social Sciences and Humanities, Warsaw

Enrollment

192 participants

Start Date

Mar 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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Interventions

BEHAVIORALAcceptance 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.

BEHAVIORALEducation

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.


Locations(1)

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

Gliwice, Poland

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NCT06266182


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