Advanced Malignant Solid NeoplasmNCT04870788
Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers
A study testing Mindfulness Relaxation, Quality-of-Life Assessment and Questionnaire Administration in people with Advanced Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial develops effective and appropriate mindfulness-based interventions that help meet the needs of Latino cancer patients and their family caregivers. Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and the sensations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm
- What is being tested?
- Mindfulness Relaxation, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 30 Sep 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
- Diagnosed with a stage III-IV solid tumor
- On active treatment
- Self-identify as Hispanic/Latino
- ECOG (Eastern Cooperative Oncology Group) performance status of =< 2
- Willing to participate in the study with a family caregiver (e.g., spouse, adult child) with whom they currently reside and who consents to participate
Who cannot join
- At least 18 years old
- Able to speak English or Spanish
- Have access to the internet
- Able to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cultural Adaptation of a Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers
This clinical trial develops effective and appropriate mindfulness-based interventions that help meet the needs of Latino cancer patients and their family caregivers. Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and the sensations. This study may help improve mental well-being and reduce stress and anxiety associated with having cancer or with a family member's cancer diagnosis.
Read the detailed description
PRIMARY OBJECTIVES:
- Systematically and culturally adapt a mindfulness-based intervention to improve psychological wellbeing in Latino patients with advanced cancer and their family caregivers.
II. Evaluate the feasibility of the adapted mindfulness-based intervention and overall study procedures in Latino patient-family caregiver dyads.
SECONDARY OBJECTIVE:
- Determine the effects of the adapted mindfulness-based intervention on the secondary outcomes of patient and caregiver psychological distress, quality of life (QOL), and patient cancer symptoms, compared to a waitlist control.
OUTLINE: Patients and their partners are randomized to 1 of 32 groups.
GROUP I: Patients and their partners participate in mindfulness program together over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations 1 time per week (QW) for 4 weeks.
GROUP II: Patients and their partners participate in mindfulness program separately over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations 1 time per week (QW) for 4 weeks.
GROUP III: Patients and their partners participate in mindfulness program either separately or together, depending on participants' preferences, as in Group I beginning 12 weeks after starting the study and completing the third study visit.
- Conditions
- Advanced Malignant Solid Neoplasm
- Being tested
- Mindfulness Relaxation, Quality-of-Life Assessment, Questionnaire Administration, Group II (mindfulness waitlist)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness RelaxationBehavioural
Also called MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction
Participate in mindfulness program
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Group II (mindfulness waitlist)Other
Patients and their partners participate in mindfulness program together or separately, depending on their preference, as in Group I beginning 12 weeks after starting the study and completing the third study visit.
| Study group | Role | What they receive |
|---|---|---|
| Group I (mindfulness program) | Experimental | Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks. Receives: Behavioral: Mindfulness Relaxation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Group II (mindfulness waitlist) |
| Group II (mindfulness program) | Experimental | Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks. Receives: Behavioral: Mindfulness Relaxation; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Group II (mindfulness waitlist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall accrual
Will calculate means, frequencies, and 90% confidence intervals (CIs), as applicable.
Measured: Up to 12 weeks
Attrition
Will calculate means, frequencies, and 90% CIs, as applicable.
Measured: Up to 12 weeks
Adherence
Will calculate means, frequencies, and 90% CIs, as applicable.
Measured: Up to 12 weeks
Acceptability
Will calculate means, frequencies, and 90% CIs, as applicable.
Measured: Up to 12 weeks
Secondary outcomes (3)
Patient and caregiver psychological distress
Will examine means, standard deviations (SDs), and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time.
Measured: At 6 and 12 weeks
Quality of life questionnaire
Will examine means, SDs, and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time.
Measured: At 6 and 12 weeks
Patient cancer symptoms
Will examine means, SDs, and distributions of survey measures for ceiling/floor effects and restrictions in range and examine change over time.
Measured: At 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start24 Mar 2021
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larkin Strong, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870788
- Sponsor's protocol ID
- 2020-1070
- Other IDs
- NCI-2021-02774, 2020-1070
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2021
- Last updated
- 17 Sep 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation of a Mindfulness-Based Intervention for Latino Cancer Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT04870788
- Acronym / sponsor ID
- 2020-1070
- Conditions
- Advanced Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 3 May 2021 (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 develops effective and appropriate mindfulness-based interventions that help meet the needs of Latino cancer patients and their family caregivers. Mindfulness-based interventions focus on building awareness of thoughts, emotions/feelings, and the sensations. This study may help improve mental well-being and reduce stress and anxiety associated with having cancer or with a family member's cancer diagnosis.
Detailed description
PRIMARY OBJECTIVES:
- Systematically and culturally adapt a mindfulness-based intervention to improve psychological wellbeing in Latino patients with advanced cancer and their family caregivers.
II. Evaluate the feasibility of the adapted mindfulness-based intervention and overall study procedures in Latino patient-family caregiver dyads.
SECONDARY OBJECTIVE:
- Determine the effects of the adapted mindfulness-based intervention on the secondary outcomes of patient and caregiver psychological distress, quality of life (QOL), and patient cancer symptoms, compared to a waitlist control.
OUTLINE: Patients and their partners are randomized to 1 of 32 groups.
GROUP I: Patients and their partners participate in mindfulness program together over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations 1 time per week (QW) for 4 weeks.
GROUP II: Patients and their partners participate in mindfulness program separately over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations 1 time per week (QW) for 4 weeks.
GROUP III: Patients and their partners participate in mindfulness program either separately or together, depending on participants' preferences, as in Group I beginning 12 weeks after starting the study and completing the third study visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (mindfulness program) | Experimental | Behavioral: Mindfulness Relaxation, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Group II (mindfulness waitlist)Patients and their partners participate together in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks. |
| Group II (mindfulness program) | Experimental | Behavioral: Mindfulness Relaxation, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Group II (mindfulness waitlist)Patients and their partners participate separately in mindfulness program over 60 minutes consisting of meeting with a mindfulness coach to build awareness of thoughts, emotions, feelings, and sensations QW for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with a stage III-IV solid tumor
- On active treatment
- Self-identify as Hispanic/Latino
- ECOG (Eastern Cooperative Oncology Group) performance status of =< 2
- Willing to participate in the study with a family caregiver (e.g., spouse, adult child) with whom they currently reside and who consents to participate
Key exclusion criteria (4 listed)
- At least 18 years old
- Able to speak English or Spanish
- Have access to the internet
- Able to provide informed consent
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 |
|---|---|---|
| Mindfulness RelaxationAlso: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress ReductionParticipate in mindfulness program | Behavioural | Group I (mindfulness program), Group II (mindfulness program) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (mindfulness program), Group II (mindfulness program) |
| Questionnaire AdministrationAncillary studies | Other | Group I (mindfulness program), Group II (mindfulness program) |
| Group II (mindfulness waitlist)Patients and their partners participate in mindfulness program together or separately, depending on their preference, as in Group I beginning 12 weeks after starting the study and completing the third study visit. | Other | Group I (mindfulness program), Group II (mindfulness program) |
Primary outcome
Overall accrual
Time frame: Up to 12 weeks
Will calculate means, frequencies, and 90% confidence intervals (CIs), as applicable.
Attrition
Time frame: Up to 12 weeks
Will calculate means, frequencies, and 90% CIs, as applicable.
Adherence
Time frame: Up to 12 weeks
Will calculate means, frequencies, and 90% CIs, as applicable.
Acceptability
Time frame: Up to 12 weeks
Will calculate means, frequencies, and 90% CIs, as applicable.
3 secondary outcomes
Patient and caregiver psychological distress
Time frame: At 6 and 12 weeks
Quality of life questionnaire
Time frame: At 6 and 12 weeks
Patient cancer symptoms
Time frame: At 6 and 12 weeks
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 17 Sep 2026.
- MD Anderson Cancer Center WebsiteLink 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. This study is not recruiting at the moment.
Larkin Strong principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Relaxation, Quality-of-Life Assessment and Questionnaire Administration in people with Advanced Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall accrual (time frame: Up to 12 weeks). 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 17 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.