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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Cognitive Behavior Therapy

    Behavioral

    Participate in CBCSM group sessions

  • Questionnaire Administration

    Other intervention

    Complete questionnaires

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Group I (CBCSM)Experimental treatment 2 interventions
Group B: Group II (no CBCSM)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
At baseline, 1, 3, 6, and 12 months
2

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).

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

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.

Time frame
Baseline to 12 months
4

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.

Time frame
Baseline to 12 months

Other outcomes

Sponsors and contacts

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