NCT07585838

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 2, 2026

Last Update Submit

May 9, 2026

Conditions

Keywords

motivational ınterventioncancerhopeself-compassionself-efficacy

Outcome Measures

Primary Outcomes (1)

  • Herth Hope Index

    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 Outcomes (2)

  • Brief Self-Compassion Scale

    Baseline, immediately after the 2-week intervention, and 1 month post-intervention

  • General Self-Efficacy Scale

    Baseline, immediately after the 2-week intervention, and 1 month post-intervention

Study Arms (2)

Experimental

EXPERIMENTAL

Participants in the intervention group will receive an individual-based Hope-Focused Motivational Interviewing program consisting of four sessions delivered twice weekly.

Behavioral: Hope-Focused Motivational Interviewing

Control

NO INTERVENTION

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).

Interventions

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.

Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, Bartın, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Experimental: Intervention Group Participants in the intervention group received the Hope-Focused Motivational Interviewing program, which consisted of four sessions delivered twice weekly. Intervention: Behavioral - Motivational Interviewing Control: Control Group Participants in the control group received routine care and no structured psychosocial intervention during the study period. Data were collected at the same time points as in the intervention group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intervention and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 14, 2026

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations