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

NCT06266182 | Recruiting

• 1 other identifier: 2020/39/B/HS6/01927
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Distress (Global Meaning Violation Scale; GMVS)

  The GMVS measures meaning-related distress. It is a 12-item questionnaire (from the original, the item "health" was removed due to the context of the study) that assesses belief (5 items) and goal violations (7 items) in response to stressors on a 5-point scale ranging from 1 (not at all) to 5 (very much). The overall score is calculated by summing the scores of all 12 items, with a possible range of 12-60. Higher scores indicate greater meaning-related distress (greater global meaning violation).

  Change from baseline to immediately, 1 month and 3 months after intervention

Secondary Outcomes (17)

• Illness perception (Brief-Illness Perception Questionnaire; B-IPQ)

  Change from baseline to immediately, 1 month and 3 months after intervention

• Global meaning (Meaning in Life Questionnaire; MLQ)

  Change from baseline to immediately, 1 month and 3 months after intervention

• Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9)

  Change from baseline to immediately, 1 month and 3 months after intervention

• Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items)

  Change from baseline to immediately, 1 month and 3 months after intervention

• Deliberate meaning-making (Core Beliefs Inventory; CBI)

  Change from baseline to immediately, 1 month and 3 months after intervention

Study Arms (2)

ACT intervention

EXPERIMENTAL

Participants in the ACT intervention arm will learn new adaptive ways to cope with difficulties (including difficult thoughts or feelings).

Behavioral: Acceptance and Commitment Therapy

Education

OTHER

Participants in the Education arm will become familiar with post-HCT recommendations. This will be a minimally enhanced usual care.

Behavioral: Education

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Also known as: ACT-based intervention, ACT

ACT intervention

Education BEHAVIORAL

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.

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Social Sciences and Humanities, Warsaw: lead
• National Science Centre, Poland: collaborator

Study Sites (1)

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

Gliwice, 44-102, Poland

RECRUITING

Related Publications (1)

• Kroemeke A, Dudek J, Kijowska M, Owen R, Sobczyk-Kruszelnicka M. The effect of an online acceptance and commitment intervention on the meaning-making process in cancer patients following hematopoietic cell transplantation: study protocol for a randomized controlled trial enhanced with single-case experimental design. Trials. 2024 Jun 18;25(1):392. doi: 10.1186/s13063-024-08235-1.

  PMID: 38890709 DERIVED

MeSH Terms

Interventions

Acceptance and Commitment Therapy; Educational Status

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics

Study Officials

• Aleksandra Kroemeke, PhD

  SWPS University (University of Social Sciences and Humanities)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Kroemeke, PhD

CONTACT

011 48 225179824; akroemeke@swps.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 20, 2024
• Study Start: March 6, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months after publication without an end date.
• Access Criteria: All those who will have an open link.

Locations

PL (1)