Hematopoietic and Lymphoid System NeoplasmNCT06246955
Acceptance and Commitment Therapy and Compassion-Based Virtual Group Therapy to Improve Psychological Wellbeing in Patients With Cancer
A study testing Behavioral Intervention: Group Therapy Session and Survey Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Behavioral Intervention: Group Therapy Session and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Chun Tao, PhD, LP
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Behavioral Intervention: Group Therapy Session, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Intervention: Group Therapy SessionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Attend virtual group therapy sessions
Survey AdministrationOther
Ancillary study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Intervention: Group Therapy Session; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From baseline to 1 month post session 6
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start8 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Tao, PhD, LP, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246955
- Sponsor's protocol ID
- 23-005161
- Other IDs
- NCI-2024-00399, 23-005161
- Status last verified
- May 2026
- First submitted
- 30 Jan 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06246955
- Acronym / sponsor ID
- 23-005161
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (group therapy sessions) | Experimental | Behavioral: Behavioral Intervention: Group Therapy Session, Other: Survey AdministrationPatients attend acceptance and commitment virtual group therapy sessions over 1.5 hours each, once a week for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Intervention: Group Therapy SessionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyAttend virtual group therapy sessions | Behavioural | Supportive care (group therapy sessions) |
| Survey AdministrationAncillary study | Other | Supportive care (group therapy sessions) |
Primary outcome
Participant perceived compassion and understanding by the group therapy provider - SCQ
Time frame: From baseline to 1 month post session 6
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)
Patients' self-reported psychological flexibility - COMPACT-15
Time frame: From baseline to 1 month post session 6
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).
Patients' self-reported psychological flexibility - Psy-Flex
Time frame: From baseline to 1 month post session 6
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.
Physician and psychological distress - PROMIS-29
Time frame: From baseline to 1 month post session 6
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.
4 secondary outcomes
Self reported mindfulness
Time frame: Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
Self-compassion
Time frame: Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
Meaning and purpose
Time frame: Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
Posttraumatic growth
Time frame: Baseline; 1 month post session 6 (not assessed at mid-group to reduce patient survey burden)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chun Tao, PhD, LP principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention: Group Therapy Session and Survey Administration in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant perceived compassion and understanding by the group therapy provider - SCQ (time frame: From baseline to 1 month post session 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.