nctId: NCT06266182 id: 2020/39/B/HS6/01927 briefTitle: The Effect of an Online ACT Intervention on Meaning-Making Process in Cancer Patients Following Hematopoietic Cell Transplantation overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2026-04 date: 2024-02-20 date: 2024-02-22 name: University of Social Sciences and Humanities, Warsaw class: OTHER name: National Science Centre, Poland briefSummary: 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 each 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 conditions: Acceptance and Commitment Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 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. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 192 type: ESTIMATED name: Acceptance and Commitment Therapy name: Education measure: Distress (Global Meaning Violation Scale; GMVS) measure: Illness perception (Brief-Illness Perception Questionnaire; B-IPQ) measure: Global meaning (Meaning in Life Questionnaire; MLQ) measure: Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9) measure: Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items) measure: Deliberate meaning-making (Core Beliefs Inventory; CBI) measure: Automatic meaning-making (Event-Related Rumination Inventory; ERRI - intrusive ruminations subscale) measure: Post-traumatic growth (the "current standing" Post-Traumatic Growth Inventory-Short Form; C-PTGI-SF ) measure: Meanings made (Meaning of Loss Codebook; MLC) measure: Anxiety and depressive symptoms (Patient Health Questionnaire-4; PHQ-4) measure: Loneliness (The Revised UCLA Loneliness Scale; R-UCLA - selected items) measure: Loneliness (the Community Life Survey) measure: Health-related quality of life (Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer; EORTC QLQ-C3) measure: Daily subjective health (Daily Subjective Health Scale) measure: Daily affect (Daily Positive and Negative Affect Scale) measure: Daily meaning-making (Event-Related Rumination Inventory-daily form; ERRI-daily form) measure: Daily meanings made (Meaning of Loss Codebook-daily form; MCL-daily form) measure: Daily psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-daily form; CompACT-daily form) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maria Skłodowska-Curie National Research Institute of Oncology Gliwice Branch, Department of Bone Marrow Transplantation and Oncohematology city: Gliwice zip: 44-102 country: Poland name: Małgorzata Sobczyk-Kruszelnicka, MD role: CONTACT phone: 011 48 322788520 email: malgorzata.sobczyk-kruszelnicka@gliwice.nio.gov.pl name: Małgorzata Sobczyk-Kruszelnicka, MD role: SUB_INVESTIGATOR lat: 50.29761 lon: 18.67658 hasResults: False