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

NCT06246955 | Recruiting

• 2 other identifiers: 23-005161NCI-2024-00399
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Self reported mindfulness

  Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)

• Self-compassion

  Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)

• Meaning and purpose

  Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)

• Posttraumatic growth

  Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)

Study Arms (1)

Supportive care (group therapy sessions)

EXPERIMENTAL

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

Behavioral: Behavioral Intervention: Group Therapy Session; Other: Survey Administration

Interventions

Behavioral Intervention: Group Therapy Session BEHAVIORAL

Attend virtual group therapy sessions

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Supportive care (group therapy sessions)

Survey Administration OTHER

Ancillary study

Supportive care (group therapy sessions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Chun Tao, PhD, LP

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: January 8, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)