- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07585838
Hope-Focused Motivational Interviewing in Cancer Patients
9. Mai 2026 aktualisiert von: Duygu Özer, PhD, Saglik Bilimleri Universitesi
Effects of Hope-Focused Motivational Interviewing on Hope, Self-Efficacy, and Self-Compassion in Cancer Patients Undergoing Radiotherapy: A Randomized Controlled Trial
This study aims to examine the effects of hope-focused motivational interviewing on levels of hope, self-efficacy, and self-compassion in patients with cancer receiving radiotherapy, using a randomized controlled design.
Studienübersicht
Status
Anmeldung auf Einladung
Intervention / Behandlung
Detaillierte Beschreibung
This study is designed as a randomized controlled experimental study with a pretest-posttest and follow-up design.
It will be conducted with individuals diagnosed with cancer who are receiving inpatient care in the Radiation Oncology unit of a City Hospital.
According to the G*Power analysis, a minimum of 46 participants (intervention = 23, control = 23) will be included in the study.
The computer-aided https://www.random.org/integers/
program will be used to assign the intervention and control groups without bias.
The intervention group will receive a "Hope-Focused Motivational Interviewing" program consisting of four sessions delivered twice weekly, while the control group will receive routine treatment and care.
Data will be collected using the "Information Form," "Herth Hope Index," "Brief Self-Compassion Scale," and "General Self-Efficacy Scale."
Measurements will be obtained before and after the intervention.
To minimize bias, data will be collected via Google Forms.
The first page of the form will include information about the study along with an informed consent statement, and participants will be required to provide their consent before proceeding.
Participants who agree to take part in the study will complete the questionnaires within approximately 15-20 minutes.
Studientyp
Interventionell
Einschreibung (Geschätzt)
46
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Bartın
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Bartın, Bartın, Türkei (türkiye), 74100
- Bartın University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- Being 18 years of age or older
- Having a diagnosis of Stage I-III cancer according to the TNM staging system Receiving radiotherapy at the study center (including adjuvant, neoadjuvant, or definitive RT)
- Being in the first week of the radiotherapy process
- Being able to read and understand Turkish and communicate at a level sufficient to participate in interviews
- Agreeing to attend the intervention sessions at scheduled times and providing written informed consent
Exclusion Criteria:
- Presence of metastatic disease (Stage IV) or recurrent cancer
- Receiving concurrent chemotherapy during the radiotherapy process
- Presence of severe psychiatric conditions that may interfere with participation or the safe implementation of the intervention (e.g., psychotic disorders, bipolar disorder in the manic phase, or severe major depression)
- Presence of moderate to severe cognitive impairment/dementia, significant attention or concentration problems, or neurological conditions that may compromise the reliability of responses
- Severe hearing or speech impairments or communication difficulties that would prevent participation in interviews or completion of questionnaires (if appropriate support cannot be provided)
- Participation in another structured psychosocial intervention program (e.g., hope-based, psychoeducational, or psychotherapeutic programs) during the study period
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Experimental
Participants in the intervention group will receive an individual-based Hope-Focused Motivational Interviewing program consisting of four sessions delivered twice weekly.
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Participants in the intervention group will receive an individual-based Hope-Focused Motivational Interviewing program consisting of four sessions delivered twice weekly.
Each session will last approximately 30-40 minutes.
The program includes the following components: (1) exploration of hope and goal setting, (2) enhancement of self-efficacy, (3) development of self-compassion, and (4) coping with barriers and creating a sustainable coping plan.
Assessments will be conducted at baseline (pre-test), post-intervention, and at 1-month follow-up.
|
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Kein Eingriff: Control
Participants in the control group will receive routine care only and will not be exposed to any structured psychosocial intervention during the study period.
Data will be collected at the same time points as the intervention group (baseline, post-test, and 1-month follow-up).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Herth Hope Index
Zeitfenster: Baseline, immediately after the 2-week intervention, and 1 month post-intervention
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The scale consists of 12 items and three subscales: (1) temporality and future, (2) positive readiness and expectancy, and (3) interconnectedness with self and others.
Items are rated on a 4-point Likert scale ranging from 0 (strongly disagree) to 3 (strongly agree).
The "temporality and future" subscale (items 1, 2, 6, and 11) assesses the temporal dimension of hope; the "positive readiness and expectancy" subscale (items 4, 7, 10, and 12) reflects the emotional-behavioral aspects of hope; and the "interconnectedness" subscale (items 3, 5, 8, and 9) measures relational and contextual aspects of hope.
Items 3 and 6 are negatively worded and are reverse scored.
The total scale score is obtained by summing responses to all items, while subscale scores are calculated by summing the corresponding items.
Total scores range from 12 to 48, with higher scores indicating greater levels of hope.
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Baseline, immediately after the 2-week intervention, and 1 month post-intervention
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Brief Self-Compassion Scale
Zeitfenster: Baseline, immediately after the 2-week intervention, and 1 month post-intervention
|
The Brief Self-Compassion Scale consists of 12 items rated on a 5-point Likert scale.
Items 1, 4, 8, 9, 11, and 12 are reverse scored.
The scale comprises two factors: self-compassion and self-criticism (or maladaptive self-compassion).
Total scores range from 12 to 60, with higher scores indicating greater levels of self-compassion.
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Baseline, immediately after the 2-week intervention, and 1 month post-intervention
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General Self-Efficacy Scale
Zeitfenster: Baseline, immediately after the 2-week intervention, and 1 month post-intervention
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The General Self-Efficacy Scale consists of 17 items rated on a 5-point Likert scale.
Items 2, 4, 5, 6, 7, 10, 11, 12, 14, 16, and 17 are reverse scored.
The scale includes three subscales: initiation, persistence, and maintenance effort.
Total scores range from 17 to 85, with higher scores indicating higher levels of self-efficacy.
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Baseline, immediately after the 2-week intervention, and 1 month post-intervention
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
15. Juni 2026
Primärer Abschluss (Geschätzt)
30. Oktober 2026
Studienabschluss (Geschätzt)
30. Dezember 2026
Studienanmeldedaten
Zuerst eingereicht
2. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Mai 2026
Zuerst gepostet (Tatsächlich)
14. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
14. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BARU-SBF-DO-2
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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