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

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Behavioral Intervention: Group Therapy Session

    Behavioral

    Attend virtual group therapy sessions

  • Survey Administration

    Other intervention

    Ancillary study

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Supportive care (group therapy sessions)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
From baseline to 1 month post session 6
2

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).

Time frame
From baseline to 1 month post session 6
3

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.

Time frame
From baseline to 1 month post session 6
4

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.

Time frame
From baseline to 1 month post session 6

Secondary outcomes

1

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).

Time frame
Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
2

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.

Time frame
Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
3

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).

Time frame
Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
4

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.

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

Other outcomes

Sponsors and contacts

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