Clinical trial NCT06246955: Acceptance and Commitment Therapy and Compassion-Based Virtual Group Therapy to Improve Psychological Wellbeing in Patients with Cancer
Official title: "Live Fully with Cancer": Assessing the Impact of an Acceptance and Commitment Therapy and Compassion-Based Virtual Group Intervention for Diverse Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant perceived compassion and understanding by the group therapy provider - SCQ
timeFrame: From baseline to 1 month post session 6
measure: Patients' self-reported psychological flexibility - COMPACT-15
timeFrame: From baseline to 1 month post session 6
measure: Patients' self-reported psychological flexibility - Psy-Flex
timeFrame: From baseline to 1 month post session 6
measure: Physician and psychological distress - PROMIS-29
timeFrame: From baseline to 1 month post session 6
Secondary outcomes:
measure: Self reported mindfulness
timeFrame: Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
measure: Self-compassion
timeFrame: Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
measure: Meaning and purpose
timeFrame: Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
measure: Posttraumatic growth
timeFrame: Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Chun Tao, PhD, LP
role: PRINCIPAL_INVESTIGATOR
References: