Hematopoietic and Lymphoid System NeoplasmNCT06015932
Group Cognitive Behavior Sessions (CBCSM) to Decrease Distress in Cancer Patients
A study testing Cognitive Behavior Therapy and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Cognitive Behavior Therapy and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Deanna Hofschulte, 507-255-2972, Hofschulte.Deanna@mayo.edu
About this study
Official title: A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To reduce psychological stress.
SECONDARY OBJECTIVES:
- 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.
- 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
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- Being tested
- Cognitive Behavior Therapy, Questionnaire Administration
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior TherapyBehavioural
Also called CBT, cognitive therapy, CT
Participate in CBCSM group sessions
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavior Therapy; Other: 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. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, 1, 3, 6, and 12 months
Secondary outcomes (6)
Change in post-traumatic growth (PTG) score
PTG will be assessed using the Patient-Reported Outcomes Measurement System (PROMIS®)-Psychosocial Impact Scale-Positive. The PROMIS assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain.
Measured: At baseline, 1, 3, 6, and 12 months
Change in self-efficacy score
Will examine predicted increase in self-efficacy associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Scores will be assessed using the Measure of Current Status-Part A (MOCS-A), which measures participants' current self-perceived status on several skills: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, express anger effectively and appropriately, and choose appropriate coping responses as needed. Ratings are made on a scale from I cannot do this at all (0) to I can do this extremely well (4).
Measured: At baseline, 1, 3, 6, and 12 months
Patient acceptability and satisfaction
Will be assessed by simple percentage, based on scores from an Institute for Healthcare Improvement 10-point Likert scale (0-10, "Would you recommend this program to your friends and family?" A score ≥7 indicates high individual satisfaction.
Measured: Baseline to 12 months
Patient attendance and feasibility
Will be assessed by simple percentage. Attendance and feasibility will be determined by the number of patients attending ≥3 sessions out of five.
Measured: Baseline to 12 months
Anxiety
Will examine predicted reductions in anxiety symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Anxiety will be measured using General Anxiety Disorder-7 (GAD-7) symptom scores, an 8-question survey. Seven questions are answered on a 0-3 scale where 0=Not at all and 3=Nearly every day. The final question is answered on a 4-point scale from Not Difficult at All to Extremely Difficult.
Measured: At baseline, 1, 3, 6, and 12 months
Depression
Will examine predicted reductions in depression symptoms associated with Cognitive Behavioral Cancer Stress Management (CBCSM) from pre-intervention to post-intervention. Level of depression will be determined using the Patient Health Questionnaire-8 (PHQ-8). The PHQ-8 is an 8-item questionnaire answered on a scale of 0-3 where 0=Not at all and 3=Nearly every day.
Measured: At baseline, 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start20 Dec 2017
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shawna L. Ehlers, Ph.D., L.P., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015932
- Sponsor's protocol ID
- 17-000947
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized Translational Trial of Cognitive Behavioral Cancer Stress Management (CBCSM) and Its Effects on Cancer Distress
- ClinicalTrials.gov ID
- NCT06015932
- Acronym / sponsor ID
- 17-000947
- Conditions
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVE:
- To reduce psychological stress.
SECONDARY OBJECTIVES:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (CBCSM) | Experimental | Behavioral: Cognitive Behavior Therapy, Other: Questionnaire AdministrationPatients 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 (no CBCSM) | Active comparator | Other: Questionnaire AdministrationPatients complete questionnaires throughout the trial and during follow-up at 1, 3, 6, and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior TherapyAlso: CBT, cognitive therapy, CTParticipate in CBCSM group sessions | Behavioural | Group I (CBCSM) |
| Questionnaire AdministrationComplete questionnaires | Other | Group I (CBCSM), Group II (no CBCSM) |
Primary outcome
Change in post-traumatic stress (PTS) score
Time frame: At baseline, 1, 3, 6, and 12 months
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.
6 secondary outcomes
Change in post-traumatic growth (PTG) score
Time frame: At baseline, 1, 3, 6, and 12 months
Change in self-efficacy score
Time frame: At baseline, 1, 3, 6, and 12 months
Patient acceptability and satisfaction
Time frame: Baseline to 12 months
Patient attendance and feasibility
Time frame: Baseline to 12 months
Anxiety
Time frame: At baseline, 1, 3, 6, and 12 months
Depression
Time frame: At baseline, 1, 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shawna L. Ehlers, Ph.D., L.P. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy and Questionnaire Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-traumatic stress (PTS) score (time frame: At baseline, 1, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.