Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients

NCT ID: NCT06015932

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2029-12-31

Brief Summary

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This clinical trial tests how well cognitive behavioral cancer stress management (CBCSM) group sessions work to decrease psychological distress in cancer patients. CBCSM teaches patients how to recognize and reduce the impacts of cancer associated stress on the biological, psychological, and social life domains.

Detailed Description

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PRIMARY OBJECTIVE:

I. To reduce psychological stress.

SECONDARY OBJECTIVES:

I. To increase post-traumatic growth (PTG). II. To increase patient self-efficacy in utilizing therapy skills. III. To estimate patient acceptability and feasibility of conducting CBCSM within the clinical setting.

IV. To estimate differences of conducting CBCSM virtually during the Public Health Emergency (PHE) versus in person pre-PHE.

V. To estimate differences of conducting CBCSM post PHE virtually with limitation to Minnesota patients only.

VI. To explore the difference using the same therapy in patients with advanced, metastatic disease in a individual setting versus patients without the advanced, metastatic disease in a group setting.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.

GROUP II: Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.

Conditions

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Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (CBCSM)

Patients participate in five CBCSM group sessions on study. Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.

Group Type EXPERIMENTAL

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

Participate in CBCSM group sessions

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Group II (no CBCSM)

Patients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months.

Group Type ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Cognitive Behavior Therapy

Participate in CBCSM group sessions

Intervention Type BEHAVIORAL

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Other Intervention Names

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CBT cognitive therapy CT

Eligibility Criteria

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Inclusion Criteria

* Eligible for the cognitive behavioral cancer stress management (CBCSM) clinical service
* Cancer diagnosis with predicted survival \> 1 year
* Cancer treatment within past 1 year or treatment planning in progress
* Age \>= 18-years
* Moderate distress screen, indicated by Impact of Event Scale-Revised (IES-R) score \>= 14 or clinical judgment
* Written informed research consent

Exclusion Criteria

* Inability to actively participate in and learn from group therapy (e.g., psychotic symptoms, neurological condition, personality pathology) as determined by clinical judgment in clinical consultation (Individual therapy or alternative group therapy will be offered)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Shawna L. Ehlers, Ph.D., L.P.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shawna L. Ehlers, Ph.D., L.P.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Deanna Hofschulte

Role: CONTACT

507-255-2972

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Deanna Hofschulte

Role: backup

507-255-2972

Related Links

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Other Identifiers

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NCI-2023-00250

Identifier Type: REGISTRY

Identifier Source: secondary_id

17-000947

Identifier Type: OTHER

Identifier Source: secondary_id

17-000947

Identifier Type: -

Identifier Source: org_study_id

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