Acceptance and Commitment Therapy and Compassion-Based Virtual Group Therapy to Improve Psychological Wellbeing in Patients With Cancer

"Live Fully With Cancer": Assessing the Impact of an Acceptance and Commitment Therapy and Compassion-Based Virtual Group Intervention for Diverse Cancer Patients

This clinical trial tests how well acceptance and commitment therapy and compassion based virtual group therapy works to improve psychological wellbeing, such as compassion, understanding, and flexibility, in patients with cancer. Receiving a cancer diagnosis, undergoing cancer treatment, and living with cancer- or treatment-related symptoms have often been found to be associated with elevated distress and decreased quality of life for individuals, even when the disease is stable or in remission. Acceptance and Commitment Therapy (ACT) has demonstrated considerable benefits on individuals' quality of life, psychological flexibility, and amelioration of psychological distress following a cancer diagnosis and in the face of uncertainty, loss, and challenges associated with cancer.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Behavioral: Behavioral Intervention: Group Therapy Session

Detailed Description

PRIMARY OBJECTIVES:

I. To assess if participants perceive compassion and understanding by the provider who facilitates the virtual group intervention.

II. To assess if participation in the ACT-based group intervention is associated with increases in patients' self-reported psychological flexibility as well as amelioration in psychological and physical distress.

SECONDARY OBJECTIVE:

I. To assess if participation in the ACT-based group intervention is associated with increases in patients' self-reported mindfulness, self-compassion, meaning and purpose, and posttraumatic growth.

OUTLINE:

Patients attend acceptance and commitment virtual group therapy sessions over 1.5 hours each, once a week for 6 weeks.

After completion of study treatment, patients are followed up at 1 month.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Chun Tao, PhD, LP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being an adult (18 years or older)
• Being a patient of Mayo Clinic Arizona
• Having a cancer diagnosis, having treatment planning in progress, undergoing cancer-related treatment, or having completed cancer within the past 2 years (in recent survivorship
• Experiencing stress or challenges related to cancer and having treatment goals that align with the purpose of the group
• Having self reported proficiency to read/write/speak English
• Expressing interest and commitment to attend all six virtual group sessions

Exclusion Criteria:

• Patients' inability to take part in and benefit from the virtual group therapy based on clinical judgment of the psychosocial oncology team member who completes the psychosocial evaluation, which may include having active suicidal or homicidal intent, experiencing uncontrolled psychotic symptoms, having untreated personality disorder/characteristics that are likely disturbing in a group setting, and/or having moderate to severe cognitive impairments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive care (group therapy sessions); Patients attend acceptance and commitment virtual group therapy sessions over 1.5 hours each, once a week for 6 weeks.	Other: Survey Administration; Ancillary study; Behavioral: Behavioral Intervention: Group Therapy Session; Attend virtual group therapy sessions; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant perceived compassion and understanding by the group therapy provider - SCQ	Will be assessed based on average scores using the 5-item Sinclair Compassion Questionnaire (SCQ), answered using a 5-point scale (strongly disagree, disagree, neutral, agree, strongly agree)	From baseline to 1 month post session 6
Patients' self-reported psychological flexibility - COMPACT-15	Will be assessed using the 15-item Comprehensive Assessment of Acceptance and Commitment Therapy Processes (COMPACT-15). Questions are answered on a scale of 0-6 (strongly disagree, moderately disagree, slightly disagree, neither agree nor disagree, slightly agree, moderately agree, strongly agree).	From baseline to 1 month post session 6
Patients' self-reported psychological flexibility - Psy-Flex	Will be assessed using the 6-item Psy-Flex scale. Questions are answered on a 5-point scale (very often, often, from time to time, seldom, very seldom) based on experiences over the past 7 days.	From baseline to 1 month post session 6
Physician and psychological distress - PROMIS-29	Will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS)-29 v2.0 Profile, which assesses pain intensity using a 0-10 numeric rating scale across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain.	From baseline to 1 month post session 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self reported mindfulness	Will be assessed using the 15-item Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF). Questions are answered on a scale of 1-5 (1-never or very rarely true, 2-rarely true, 3-sometimes true, 4-often true, 5-very often or always true).	Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
Self-compassion	Will be assessed using the the 12- item Self-Compassion Scale Short Form (SCS-SF). Questions are answered on a scale of 1-5 where 1 = almost never and 5 = almost always.	Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
Meaning and purpose	Will be assessed using the 5-item Presence of Meaning subscale of the Meaning in Life Questionnaire (MLQ). Questions are answered on a 7-point scale (absolutely untrue, mostly untrue, somewhat untrue, cannot say true or false, somewhat true, mostly true, absolutely true).	Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
Posttraumatic growth	Will be assessed using the 10-item Posttraumatic Growth Inventory - Short Form (PTGI-SF). Questions are answered on a scale of 0-5 where 0 = I did not experience this change following my cancer diagnosis; 1 = I experienced this change to a very small degree following my cancer diagnosis; 2 = I experienced this change to a small degree following my cancer diagnosis; 3 = I experienced this change to a moderate degree following my cancer diagnosis; 4 = I experienced this change to a great degree following my cancer diagnosis; and 5 = I experienced this change to a very great degree following my cancer diagnosis.	Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Chun Tao, PhD, LP, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: 23-005161 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2024-00399 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No