- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07585838
Hope-Focused Motivational Interviewing in Cancer Patients
May 9, 2026 updated by: 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.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bartın
-
Bartın, Bartın, Turkey (Türkiye), 74100
- Bartın University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Participants in the intervention group will receive an individual-based Hope-Focused Motivational Interviewing program consisting of four sessions delivered twice weekly.
|
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.
|
|
No Intervention: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Herth Hope Index
Time Frame: Baseline, immediately after the 2-week intervention, and 1 month post-intervention
|
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.
|
Baseline, immediately after the 2-week intervention, and 1 month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Self-Compassion Scale
Time Frame: 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.
|
Baseline, immediately after the 2-week intervention, and 1 month post-intervention
|
|
General Self-Efficacy Scale
Time Frame: Baseline, immediately after the 2-week intervention, and 1 month post-intervention
|
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.
|
Baseline, immediately after the 2-week intervention, and 1 month post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
May 2, 2026
First Submitted That Met QC Criteria
May 9, 2026
First Posted (Actual)
May 14, 2026
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 9, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BARU-SBF-DO-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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