protocolSection identificationModule nctId: NCT06266182, orgStudyIdInfo 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, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Social Sciences and Humanities, Warsaw, class: OTHER, collaborators name: National Science Centre, Poland, descriptionModule 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., conditionsModule conditions: Hematopoietic Cell Transplantation Recipient, conditions: Acceptance and Commitment Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 192, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance and Commitment Therapy, interventions name: Education, outcomesModule primaryOutcomes measure: Distress (Global Meaning Violation Scale; GMVS), secondaryOutcomes measure: Illness perception (Brief-Illness Perception Questionnaire; B-IPQ), secondaryOutcomes measure: Global meaning (Meaning in Life Questionnaire; MLQ), secondaryOutcomes measure: Psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-9; CompACT-9), secondaryOutcomes measure: Coping self-efficacy (Coping Self-Efficacy Scale; CSE - selected items), secondaryOutcomes measure: Deliberate meaning-making (Core Beliefs Inventory; CBI), secondaryOutcomes measure: Automatic meaning-making (Event-Related Rumination Inventory; ERRI - intrusive ruminations subscale), secondaryOutcomes measure: Post-traumatic growth (the "current standing" Post-Traumatic Growth Inventory-Short Form; C-PTGI-SF ), secondaryOutcomes measure: Meanings made (Meaning of Loss Codebook; MLC), secondaryOutcomes measure: Anxiety and depressive symptoms (Patient Health Questionnaire-4; PHQ-4), secondaryOutcomes measure: Loneliness (The Revised UCLA Loneliness Scale; R-UCLA - selected items), secondaryOutcomes measure: Loneliness (the Community Life Survey), secondaryOutcomes measure: Health-related quality of life (Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer; EORTC QLQ-C3), secondaryOutcomes measure: Daily subjective health (Daily Subjective Health Scale), secondaryOutcomes measure: Daily affect (Daily Positive and Negative Affect Scale), secondaryOutcomes measure: Daily meaning-making (Event-Related Rumination Inventory-daily form; ERRI-daily form), secondaryOutcomes measure: Daily meanings made (Meaning of Loss Codebook-daily form; MCL-daily form), secondaryOutcomes measure: Daily psychological flexibility (Comprehensive Assessment of Acceptance and Commitment Therapy Processes-daily form; CompACT-daily form), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations 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, contacts name: Małgorzata Sobczyk-Kruszelnicka, MD, role: CONTACT, phone: 011 48 322788520, email: malgorzata.sobczyk-kruszelnicka@gliwice.nio.gov.pl, contacts name: Małgorzata Sobczyk-Kruszelnicka, MD, role: SUB_INVESTIGATOR, geoPoint lat: 50.29761, lon: 18.67658, hasResults: False