NCT06015932

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Dec 2017Dec 2029

Study Start

First participant enrolled

December 20, 2017

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

12 years

First QC Date

August 23, 2023

Last Update Submit

July 25, 2025

Conditions

Hematopoietic and Lymphoid System NeoplasmMalignant Solid NeoplasmMetastatic Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Change in post-traumatic stress (PTS) score

    Each item on the PTS is rated on a 5-point scale (0=Not at all; 1=A little bit; 2=Moderately; 3=Quite a bit, and 4=Extremely). The total score can range from 0 to 36 with higher scores indicating greater severity of posttraumatic stress disorder.

    At baseline, 1, 3, 6, and 12 months

Secondary Outcomes (6)

  • Change in post-traumatic growth (PTG) score

    At baseline, 1, 3, 6, and 12 months

  • Change in self-efficacy score

    At baseline, 1, 3, 6, and 12 months

  • Patient acceptability and satisfaction

    Baseline to 12 months

  • Patient attendance and feasibility

    Baseline to 12 months

  • Anxiety

    At baseline, 1, 3, 6, and 12 months

  • +1 more secondary outcomes

Study Arms (2)

Group I (CBCSM)

EXPERIMENTAL

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.

Behavioral: Cognitive Behavior TherapyOther: Questionnaire Administration

Group II (no CBCSM)

ACTIVE COMPARATOR

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

Other: Questionnaire Administration

Interventions

Cognitive Behavior TherapyBEHAVIORAL

Participate in CBCSM group sessions

Also known as: CBT, cognitive therapy, CT
Group I (CBCSM)
Questionnaire AdministrationOTHER

Complete questionnaires

Group I (CBCSM)Group II (no CBCSM)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Shawna L. Ehlers, Ph.D., L.P.

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Deanna Hofschulte

CONTACT

507-255-2972Hofschulte.Deanna@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 29, 2023

Study Start

December 20, 2017

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

July 29, 2025

Record last verified: 2025-07

Locations

US(1)